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terugval","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11153274,"uuid":"297d783e-9f27-4d59-a97e-df9781544069","attributeTranslation":"Lucha contra el Osteosarcoma desde el diagnóstico hasta la recaída a través de una plataforma de estudio evolutiva de investigación europea","language":7,"languageDescription":"Spanish"},{"id":11153276,"uuid":"297d783e-9f27-4d59-a97e-df9781544069","attributeTranslation":"Combattre l’ostéosarcome avec une étude plateforme évolutive européenne, du diagnostic à la rechute de la maladie","language":34,"languageDescription":"French (France)"}],"publicTitle":"Fight Osteosarcoma Through European Research evolving study platform from diagnosis to relapse (FOSTER evolving study platform)","publicTitleTranslations":[{"id":11153393,"uuid":"c9745777-1a54-4b02-bad8-e2617dd76123","attributeTranslation":"Razem przeciw kostniakomięsakowi - od diagnozy do nawrotu choroby - Europejska Platforma Badawcza 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(Netherlands)"},{"id":11153392,"uuid":"c9745777-1a54-4b02-bad8-e2617dd76123","attributeTranslation":"Combattre l’ostéosarcome avec une étude plateforme évolutive européenne, du diagnostic à la rechute de la maladie","language":34,"languageDescription":"French (France)"}],"shortTitle":"2025/4106","secondaryIdentifyingNumbers":{"additionalRegistries":[]}},"trialInformation":{"trialCategory":{"isLowIntervention":false,"trialPhase":"5","trialCategory":"2","justificationForTrialCategory":"Being phases III clinical trial, the category according to the European Regulation is 2.","trialCategoryId":122742},"medicalCondition":{"partIMedicalConditions":[{"id":139163,"medicalCondition":"Osteosarcoma","medicalConditionTranslations":[{"id":11153010,"uuid":"54ef58e2-51a4-4b9f-a2e4-035e611206e9","attributeTranslation":"Osteosarcoom","language":37,"languageDescription":"Dutch 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event-free survival (EFS) rate of the cohort overalldifferent treatment sequences.\nFor FOSTER-CabOS (first randomization) : To assess efficacy in terms of EFS of cabozantinib compared to best supportive care (BSC) as maintenance therapy after first-line chemotherapy considering EFS improvement in one or both of the following datasets : \n- patients in complete remission (CR) at the end of first-line therapy (stratum-1), \n- the whole randomised dataset, including patients with residual persistent stable disease after first-line treatment (non-resectable primary tumour, or metastatic disease not be completely resected), i.e. strata 1 and 2.","mainObjectiveTranslations":[{"id":11153385,"uuid":"203dce11-8757-4b06-a417-32c04df5890a","attributeTranslation":"De l’étude évolutive plateforme FOSTER : Evaluer le taux de Survie Sans Evènement (SSE) à 3 ans de la cohorte sur l'ensemble des différents traitements séquentiels.\nPour FOSTER-CabOS (première randomisation) : Évaluer l'efficacité en termes de SSE du cabozantinib par rapport aux soins de support en tant que traitement d'entretien après une chimiothérapie de première ligne, en tenant compte de l'amélioration de la SSE dans l'un ou les deux ensembles de données suivants: \n- les patients en rémission complète (RC) à la fin du traitement de première ligne (strate 1), \n- l'ensemble des données randomisées, y compris les patients présentant une maladie résiduelle persistante et stable après le traitement de première ligne (tumeur primaire non résécable ou maladie métastatique dont la résection est incomplète), c’est-à-dire strate 1 et 2.","language":34,"languageDescription":"French (France)"},{"id":11153386,"uuid":"203dce11-8757-4b06-a417-32c04df5890a","attributeTranslation":"Para la plataforma del estudio FOSTER-evolving: Evaluar la eficacia de la cohorte en su conjunto de los tratamientos secuenciales en términos de supervivencia libre de eventos (SLE) a 3 años.\nPara FOSTER-CabOS (primera aleatorización) : Evaluar eficacia en terminos de Supervivencia libre de Enfermedad (EFS en inglés) de Cabozantinib comparado con la Mejor Atención de Apoyo como tratamiento de mantenimiento tras la quimioterapia de primera linea considerando mejora en la EFS de uno o dos de los siguientes datos: pacientes en completa remisión (CR) al final del tratamiento de primera línea (estrato-1). Todo el conjunto de datos aleatorizados, incluidos los pacientes con enfermedad residual estable tras el tratamiento de primera línea (tumor primario no resecable o enfermedad metastásica no resecada por completo), es decir, los estratos 1 y 2.","language":7,"languageDescription":"Spanish"},{"id":11153388,"uuid":"203dce11-8757-4b06-a417-32c04df5890a","attributeTranslation":"W ramach platformy badawczej FOSTER-Evolving: Ocena 3-letniego wskaźnika przeżycia wolnego od zdarzeń (EFS) w całej kohorcie w różnych sekwencjach leczenia.\nW ramach FOSTER-CabOS (pierwsza randomizacja) :Ocena skuteczności kabozantynibu pod względem czasu przeżycia wolnego od zdarzeń EFS w porównaniu ze standardową opieką medyczną (BSC) jako leczenia podtrzymującego po chemioterapii pierwszej linii, z uwzględnieniem poprawy EFS w jednym lub obu z następujących zbiorów danych: \n– pacjenci w całkowitej remisji (CR) na zakończenie terapii pierwszej linii (stratum 1),\n– cała randomizowana populacja badania, obejmująca pacjentów z chorobą resztkową utrzymującą się stabilną po leczeniu pierwszej linii (nieoperacyjny guz pierwotny lub choroba przerzutowa której nie można całkowicie usunąć chirurgicznie), tj.stratum 1 i stratum 2","language":19,"languageDescription":"Polish"},{"id":11153387,"uuid":"203dce11-8757-4b06-a417-32c04df5890a","attributeTranslation":"Per lo studio evolutivo della piattaforma FOSTER : Valutare il tasso di sopravvivenza libera da eventi (EFS) a 3 anni della coorte nel suo complesso in base diverse sequenze di trattamento.\nPer FOSTER-CabOS (prima randomizzazione) : Valutare l'efficacia in termini di EFS di cabozantinib rispetto alla migliore terapia di supporto (BSC) come terapia di mantenimento dopo chemioterapia di prima linea, considerando il miglioramento dell'EFS in uno o entrambi i seguenti set di dati: ● pazienti in remissione completa (CR) alla fine della terapia di prima linea (strato 1); ● l'intero set di dati randomizzato, inclusi i pazienti con malattia residua stabile dopo il trattamento di prima linea (tumore primario non resecabile o malattia metastatica non completamente resecabile), ovvero strati 1 e 2.","language":14,"languageDescription":"Italian"},{"id":11153384,"uuid":"203dce11-8757-4b06-a417-32c04df5890a","attributeTranslation":"Voor het FOSTER onderzoeksplatform: Het beoordelen van het percentage 3-jaars veranderingsvrije overleving (EFS) van het cohort als geheel de verschillende behandelingsreeks\nVoor FOSTER-CabOS,(eerste randomisatie) : Het beoordelen van de werkzaamheid in termen van EFS van cabozantinib in vergelijking met de beste standaard zorg als onderhoudsbehandeling na eerstelijns chemotherapie kijkend naar de verbetering in EFS in een of beide van de volgende datasets:\n- patienten met complete remissie (CR) aan het eind van de eerstelijns therapie (stratum-1)\n- de gehele gerandomiseerde dataset, inclusief patienten met resterende, stabiele ziekte na de eerstelijns therapie (niet-opereerbare primaire tumor, of gemetastaseerde ziekte niet volledig kan worden verwijderd), d.w.z. strata 1 en 2","language":37,"languageDescription":"Dutch (Netherlands)"}],"secondaryObjectives":[{"id":473635,"number":1,"secondaryObjective":"For FOSTER evolving study platform : To evaluate the feasibility of and compliance with the first line conventional chemotherapy.","secondaryObjectiveTranslations":[{"id":11153396,"uuid":"4f941f21-2e2a-4084-918b-d0ae074e726c","attributeTranslation":"De l’étude évolutive plateforme FOSTER : Evaluer la faisabilité et l'observance des traitements de chimiothérapie standard de première ligne","language":34,"languageDescription":"French (France)"},{"id":11153395,"uuid":"4f941f21-2e2a-4084-918b-d0ae074e726c","attributeTranslation":"W ramach platformy badawczej FOSTER-Evolving : Ocena wykonalności i zgodności ze standardową chemioterapią pierwszego rzutu.","language":19,"languageDescription":"Polish"},{"id":11153394,"uuid":"4f941f21-2e2a-4084-918b-d0ae074e726c","attributeTranslation":"Per lo studio evolutivo della piattaforma FOSTER : Valutare la fattibilità e l'aderenza alla chemioterapia convenzionale di prima linea.","language":14,"languageDescription":"Italian"},{"id":11153398,"uuid":"4f941f21-2e2a-4084-918b-d0ae074e726c","attributeTranslation":"Voor het FOSTER onderzoeksplatform: De haalbaarheid van en naleving van de eerstelijns conventionele chemotherapie evalueren.","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11153397,"uuid":"4f941f21-2e2a-4084-918b-d0ae074e726c","attributeTranslation":"Para la plataforma del estudio FOSTER-evolving: Evaluar la viabilidad y la adherencia a los tratamientos quimioterápicos convencionales de primera linea.","language":7,"languageDescription":"Spanish"}]},{"id":473636,"number":2,"secondaryObjective":"For FOSTER evolving study platform : To estimate the proportion of EFS and alive patients after the first line conventional chemotherapy.","secondaryObjectiveTranslations":[{"id":11153399,"uuid":"3e06de75-bd84-4894-8be0-be5760c0cd91","attributeTranslation":"Voor het FOSTER onderzoeksplatform : Het percentage ziektevrije en EFS na de eerstelijns conventionele chemotherapie schatten.","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11153402,"uuid":"3e06de75-bd84-4894-8be0-be5760c0cd91","attributeTranslation":"Para la plataforma del estudio FOSTER-evolving: Estimar la proporción de EFS de enfermedad y vivos tras el tratamiento quimioterápico convencional de primera linea.","language":7,"languageDescription":"Spanish"},{"id":11153401,"uuid":"3e06de75-bd84-4894-8be0-be5760c0cd91","attributeTranslation":"W ramach platformy badawczej FOSTER-Evolving : Oszacowanie odsetka EFS od choroby i żyjących po standardowej chemioterapii pierwszego rzutu.","language":19,"languageDescription":"Polish"},{"id":11153400,"uuid":"3e06de75-bd84-4894-8be0-be5760c0cd91","attributeTranslation":"Per lo studio evolutivo della piattaforma FOSTER : Stimare la percentuale di EFS e liberi da malattia dopo la chemioterapia convenzionale di prima linea.","language":14,"languageDescription":"Italian"},{"id":11153403,"uuid":"3e06de75-bd84-4894-8be0-be5760c0cd91","attributeTranslation":"De l’étude évolutive plateforme FOSTER :Estimer la proportion de EFS et en vie après le traitement de chimiothérapie standard de 1ère ligne.","language":34,"languageDescription":"French (France)"}]},{"id":473637,"number":3,"secondaryObjective":"For FOSTER evolving study platform : To assess the 3-year overall survival (OS) rate of the cohort overall different treatment sequences.","secondaryObjectiveTranslations":[{"id":11153404,"uuid":"b9974c45-3b7d-4de7-90a8-68c954e3a96a","attributeTranslation":"Voor het FOSTER onderzoeksplatform : Het beoordelen van het percentage 3-jaars totale overleving (OS) van het cohort als geheel te beoordelen, rekening houdend met alle behandelingssequenties.","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11153406,"uuid":"b9974c45-3b7d-4de7-90a8-68c954e3a96a","attributeTranslation":"De l’étude évolutive plateforme FOSTER : Évaluer le taux de survie globale (SG) à 3 ans sur l'ensemble de la cohorte en considérant les différentes traitements séquentiels.","language":34,"languageDescription":"French (France)"},{"id":11153407,"uuid":"b9974c45-3b7d-4de7-90a8-68c954e3a96a","attributeTranslation":"Per lo studio evolutivo della piattaforma FOSTER : Valutare il tasso di sopravvivenza globale (OS) a 3 anni dell'intera coorte, tenendo conto di diverse sequenze di trattamento.","language":14,"languageDescription":"Italian"},{"id":11153408,"uuid":"b9974c45-3b7d-4de7-90a8-68c954e3a96a","attributeTranslation":"W ramach platformy badawczej FOSTER-Evolving : Ocena 3-letniego wskaźnika przeżycia całkowitego (OS) w całej kohorcie, biorąc pod uwagę wszystkie sekwencji leczenia.","language":19,"languageDescription":"Polish"},{"id":11153405,"uuid":"b9974c45-3b7d-4de7-90a8-68c954e3a96a","attributeTranslation":"Para la plataforma del estudio FOSTER-evolving: Evaluar la tasa de supervivencia global (SG) a 3 años de la cohorte en su conjunto, teniendo en cuenta todas las secuencias de tratamiento.","language":7,"languageDescription":"Spanish"}]},{"id":473638,"number":4,"secondaryObjective":"For FOSTER evolving study platform : To assess the 5-year event-free survival (EFS) rate of the cohort overall different treatment sequences.","secondaryObjectiveTranslations":[{"id":11153413,"uuid":"0bb41f5b-25df-4b0c-adc7-d2f04bf132e5","attributeTranslation":"Per lo studio evolutivo della piattaforma FOSTER : Valutare l'EFS a 5 anni dell'intera coorte, tenendo conto di diverse sequenze di trattamento.","language":14,"languageDescription":"Italian"},{"id":11153410,"uuid":"0bb41f5b-25df-4b0c-adc7-d2f04bf132e5","attributeTranslation":"Voor het FOSTER onderzoeksplatform : Het beoordelen van het percentage 5-jaars veranderingsvrije overleving (EFS) van het cohort als geheel te beoordelen, rekening houdend met alle behandelingssequenties.","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11153412,"uuid":"0bb41f5b-25df-4b0c-adc7-d2f04bf132e5","attributeTranslation":"W ramach platformy badawczej FOSTER-Evolving : Ocena 5-letniego odsetka przeżycia wolnego od zdarzeń (EFS) w całej kohorcie, biorąc pod uwagę wszystkie sekwencji leczenia.","language":19,"languageDescription":"Polish"},{"id":11153409,"uuid":"0bb41f5b-25df-4b0c-adc7-d2f04bf132e5","attributeTranslation":"De l’étude évolutive plateforme FOSTER : Evaluer le taux de Survie Sans Evènement (SSE) à 5 ans sur l'ensemble en considérant les différents traitements séquentiels.","language":34,"languageDescription":"French (France)"},{"id":11153411,"uuid":"0bb41f5b-25df-4b0c-adc7-d2f04bf132e5","attributeTranslation":"Para la plataforma del estudio FOSTER-evolving: Evaluar la tasa de supervivencia libre de eventos (EFS) a 5 años de la cohorte en su conjunto, teniendo en cuenta todas las secuencias de tratamiento.","language":7,"languageDescription":"Spanish"}]},{"id":473639,"number":5,"secondaryObjective":"For FOSTER evolving study platform : To describe treatment sequences in relation to OS, EFS, and adverse events.","secondaryObjectiveTranslations":[{"id":11153417,"uuid":"33711874-8a74-47c6-a2d0-f2f7db7b0422","attributeTranslation":"De l’étude évolutive plateforme FOSTER : Décrire les traitements séquentiels en relation avec la SG, la SSE et les évènements indésirables","language":34,"languageDescription":"French (France)"},{"id":11153415,"uuid":"33711874-8a74-47c6-a2d0-f2f7db7b0422","attributeTranslation":"Per lo studio evolutivo della piattaforma FOSTER : Descrivere le sequenze di trattamento in relazione a OS, EFS ed eventi avversi (AE)","language":14,"languageDescription":"Italian"},{"id":11153414,"uuid":"33711874-8a74-47c6-a2d0-f2f7db7b0422","attributeTranslation":"Para la plataforma del estudio FOSTER-evolving: Describir secuencias de tratamiento en relacion a la SG, SLE y eventos adversos.","language":7,"languageDescription":"Spanish"},{"id":11153418,"uuid":"33711874-8a74-47c6-a2d0-f2f7db7b0422","attributeTranslation":"W ramach platformy badawczej FOSTER-Evolving : Opis sekwencji leczenia w odniesieniu do OS, EFS i zdarzeń niepożądanych.","language":19,"languageDescription":"Polish"},{"id":11153416,"uuid":"33711874-8a74-47c6-a2d0-f2f7db7b0422","attributeTranslation":"Voor het FOSTER onderzoeksplatform : Het beschrijven van behandelingsreeksen in relatie tot OS, EFS en bijwerkingen.","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":473640,"number":6,"secondaryObjective":"For FOSTER evolving study platform : To evaluate quality of life (QoL) using validated instruments, including: • European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), • Pediatric Quality of Life Inventory (PedsQL), • Functional outcome assessed by the Toronto Extremity Salvage Score (TESS).","secondaryObjectiveTranslations":[{"id":11153420,"uuid":"ca6fe060-2789-4586-abcd-88e1d36a5998","attributeTranslation":"W ramach platformy badawczej FOSTER-Evolving : Ocena jakości życia (QoL) przy użyciu sprawdzonych narzędzi, w tym:\n• Kwestionariusz jakości życia Europejskiej Organizacji Badań i Leczenia Raka Core 30 (EORTC QLQ-C30),\n• Inwentarz jakości życia dzieci (PedsQL),\n• Wynik funkcjonalny oceniany za pomocą skali Toronto Extremity Salvage Score (TESS).","language":19,"languageDescription":"Polish"},{"id":11153422,"uuid":"ca6fe060-2789-4586-abcd-88e1d36a5998","attributeTranslation":"Para la plataforma del estudio FOSTER-evolving: Evaluar la calidad de vida mediante cuestioniarios de Calidad de vida de la European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30, Pediatric Quality of Life Inventory (PaedsQL), resultados funcionales (Toronto Extremity Salvage score (TESS))","language":7,"languageDescription":"Spanish"},{"id":11153419,"uuid":"ca6fe060-2789-4586-abcd-88e1d36a5998","attributeTranslation":"Voor het FOSTER onderzoeksplatform : De kwaliteit van leven (QoL) evalueren met behulp van gevalideerde instrumenten, waaronder:\n• European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30),\n• Pediatric Quality of Life Inventory (PedsQL),\n• Functionele uitkomst beoordeeld door de Toronto Extremity Salvage Score (TESS).","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11153421,"uuid":"ca6fe060-2789-4586-abcd-88e1d36a5998","attributeTranslation":"Per lo studio evolutivo della piattaforma FOSTER : Valutare la qualità della vita (QoL) utilizzando strumenti validati, tra cui: ● Questionario sulla qualità della vita dell'Organizzazione europea per la ricerca e il trattamento del cancro Core 30 (EORTC QLQ-C30); ● Inventario sulla qualità della vita pediatrica (PedsQL); ● Risultato funzionale valutato dal Toronto Extremity Salvage Score (TESS).","language":14,"languageDescription":"Italian"},{"id":11153423,"uuid":"ca6fe060-2789-4586-abcd-88e1d36a5998","attributeTranslation":"De l’étude évolutive plateforme FOSTER : Évaluer la qualité de vie (QoL) à l'aide d'outils validés, notamment :\n• Questionnaire de qualité de vie Core 30 de l'Organisation européenne pour la recherche et le traitement du cancer (EORTC QLQ-C30),\n• Inventaire de qualité de vie pédiatrique (PedsQL),\n• le score fonctionnel évalué par le Toronto Extremity Salvage Score (TESS).","language":34,"languageDescription":"French (France)"}]},{"id":473641,"number":7,"secondaryObjective":"For FOSTER evolving study platform : To evaluate the prognostic value of clinical and biological factors, including but not limited to the G1/G2 signature determined at diagnosis, assessed by RNA sequencing or by simpler methods (e.g., immunohistochemistry on FFPE blocks).","secondaryObjectiveTranslations":[{"id":11153425,"uuid":"0e68a056-0906-42f8-933b-b08c96a954b4","attributeTranslation":"De l’étude évolutive plateforme FOSTER : Évaluer la valeur pronostique des facteurs cliniques et biologiques, y compris, mais sans s'y limiter, la signature G1/G2 déterminée au moment du diagnostic, évaluée par séquençage de l'ARN ou par des méthodes plus simples (par exemple, immunohistochimie sur des blocs FFPE).","language":34,"languageDescription":"French (France)"},{"id":11153428,"uuid":"0e68a056-0906-42f8-933b-b08c96a954b4","attributeTranslation":"Voor het FOSTER onderzoeksplatform : De prognostische waarde van klinische en biologische factoren evalueren, met inbegrip van maar niet beperkt tot de G1/G2-signatuur die bij de diagnose wordt vastgesteld, beoordeeld door middel van RNA-sequencing of eenvoudigere methoden (bijv. immunohistochemie op FFPE-blokken).","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11153426,"uuid":"0e68a056-0906-42f8-933b-b08c96a954b4","attributeTranslation":"W ramach platformy badawczej FOSTER-Evolving : Ocena wartości prognostycznej czynników klinicznych i biologicznych, w tym między innymi sygnatury G1/G2 określonej w momencie diagnozy, ocenianej za pomocą sekwencjonowania RNA lub prostszych metod (np. immunohistochemii na blokach FFPE).","language":19,"languageDescription":"Polish"},{"id":11153424,"uuid":"0e68a056-0906-42f8-933b-b08c96a954b4","attributeTranslation":"Per lo studio evolutivo della piattaforma FOSTER : Esaminare il valore prognostico dei fattori clinici e biologici, tra cui, a titolo esemplificativo ma non esaustivo, la signature G1/G2 determinata alla diagnosi, valutata mediante sequenziamento dell'RNA o mediante metodi più semplici (ad esempio, immunoistochimica su blocchi FFPE).","language":14,"languageDescription":"Italian"},{"id":11153427,"uuid":"0e68a056-0906-42f8-933b-b08c96a954b4","attributeTranslation":"Para la plataforma del estudio FOSTER-evolving: Evaluar el valor pronóstico de factores clinicos y biológicos, incluyendo pero no limitado a la firma G1/G2 determinada en el diagnóstico, evaluada mediante secuenciación del RNA o mediante métodos mas simples ( ej. Inmunohistoquímica en bloques de parafina).","language":7,"languageDescription":"Spanish"}]},{"id":473642,"number":8,"secondaryObjective":"For FOSTER evolving study platform : To explore potential differences in OS and EFS between the different sequential treatment regimens, should emerging evidence from upcoming publications suggest a differential effect.","secondaryObjectiveTranslations":[{"id":11153432,"uuid":"cc5ff734-0d2a-456f-aa65-1e3e53f6cb86","attributeTranslation":"Para la plataforma del estudio FOSTER-evolving: Explorar las posibles diferencias en la SG y la SSE entre los distintos regímenes de tratamiento secuencial, en caso de que las pruebas emergentes de las próximas publicaciones sugieran un efecto diferencial.","language":7,"languageDescription":"Spanish"},{"id":11153429,"uuid":"cc5ff734-0d2a-456f-aa65-1e3e53f6cb86","attributeTranslation":"Voor het FOSTER onderzoeksplatform : Het onderzoeken van potentiële verschillen in algehele overleving (OS) en gebeurtenisvrije overleving (EFS) tussen de verschillende behandelingsschema's, mocht nieuw bewijs uit toekomstige publicaties een werkelijk effect suggereren.","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11153430,"uuid":"cc5ff734-0d2a-456f-aa65-1e3e53f6cb86","attributeTranslation":"Per lo studio evolutivo della piattaforma FOSTER : Esplorare le potenziali differenze in termini di OS ed EFS tra i diversi regimi di trattamento sequenziali, qualora le prove emergenti dalle prossime pubblicazioni suggerissero un effetto differenziale.","language":14,"languageDescription":"Italian"},{"id":11153431,"uuid":"cc5ff734-0d2a-456f-aa65-1e3e53f6cb86","attributeTranslation":"De l’étude évolutive plateforme FOSTER : Explorer les différences potentielles en termes de survie globale (SG) et de survie sans événement (SSE) entre les différents schémas thérapeutiques séquentiels, si les données émergentes issues des prochaines publications suggèrent un effet différentiel.","language":34,"languageDescription":"French (France)"},{"id":11153433,"uuid":"cc5ff734-0d2a-456f-aa65-1e3e53f6cb86","attributeTranslation":"W ramach platformy badawczej FOSTER-Evolving : Zbadanie potencjalnych różnic w OS i EFS pomiędzy różnymi sekwencyjnymi schematami leczenia, w przypadku gdy nowe dane z publikacji będą wskazywać na zróżnicowany efekt.","language":19,"languageDescription":"Polish"}]},{"id":473643,"number":9,"secondaryObjective":"For FOSTER evolving study platform : To implement biological sample collection (tumor tissue, blood, plasma) from primary tumors and metastases before and during surgery, and at relapse/progression, for the study of circulating tumor components (e.g., ctDNA, circulating proteins).","secondaryObjectiveTranslations":[{"id":11153436,"uuid":"e1df884a-8f6f-4044-910c-2563530ac633","attributeTranslation":"Voor het FOSTER onderzoeksplatform : Het implementeren van biologische materialen (tumorweefsel, bloed, plasma) verzamelen van primaire tumoren en uitzaaiingen voorafgaand en tijdens de operatie en bij terugkeer/verergering van de tumor, voor het bestuderen van tumoronderdelen in de circulatie (bijv. ctDNA, eiwitten in de circulatie)","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11153437,"uuid":"e1df884a-8f6f-4044-910c-2563530ac633","attributeTranslation":"De l’étude évolutive plateforme FOSTER : Mettre en place un système de prélèvement d'échantillons biologiques (tissu tumoral, sang, plasma) provenant de tumeurs primaires et de métastases avant, pendant la chirurgie et lors de la rechute/progression, afin d'étudier les composants tumoraux circulants (par exemple, l'ADNct, les protéines circulantes).","language":34,"languageDescription":"French (France)"},{"id":11153438,"uuid":"e1df884a-8f6f-4044-910c-2563530ac633","attributeTranslation":"W ramach platformy badawczej FOSTER-Evolving : Pobieranie próbek biologicznych (tkanki nowotworowej, krwi, osocza) z guzów pierwotnych i przerzutów przed operacją, i w jej trakcie oraz w przypadku nawrotu/progresji choroby w celu zbadania krążących składników nowotworowych (np. ctDNA, białek krążących).","language":19,"languageDescription":"Polish"},{"id":11153434,"uuid":"e1df884a-8f6f-4044-910c-2563530ac633","attributeTranslation":"Per lo studio evolutivo della piattaforma FOSTER : Implementare la raccolta di campioni biologici (tessuto tumorale, sangue, plasma) da tumori primari e metastasi prima e durante l'intervento chirurgico e in caso di recidiva/progressione, per lo studio dei componenti tumorali circolanti (ad esempio, ctDNA, proteine circolanti).","language":14,"languageDescription":"Italian"},{"id":11153435,"uuid":"e1df884a-8f6f-4044-910c-2563530ac633","attributeTranslation":"Para la plataforma del estudio FOSTER-evolving: Implementar recogida de muestras (tejido de tumor, sangre, plasma) de tumores primarios y metástasis antes, y durante la cirugía, y en la recaída/progresión, para el estudio de componentes circulantes del tumor (ej. ctDNA, proteínas circulantes).","language":7,"languageDescription":"Spanish"}]},{"id":473644,"number":10,"secondaryObjective":"For FOSTER evolving study platform : To establish an imaging repository for future radiological and radiomic studies from diagnosis to relapse.","secondaryObjectiveTranslations":[{"id":11153441,"uuid":"a22a41c2-dc0e-4f98-9612-83ac6a2dfd43","attributeTranslation":"Voor het FOSTER onderzoeksplatform : Het opzetten van een beelvormingsarchief voor toekomstig radiologisch en radiomisch onderzoek van diagnose tot terugval.","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11153439,"uuid":"a22a41c2-dc0e-4f98-9612-83ac6a2dfd43","attributeTranslation":"W ramach platformy badawczej FOSTER-Evolving : Stworzenie repozytorium obrazów do przyszłych badań radiologicznych i radiomicznych od momentu diagnozy do nawrotu choroby.","language":19,"languageDescription":"Polish"},{"id":11153443,"uuid":"a22a41c2-dc0e-4f98-9612-83ac6a2dfd43","attributeTranslation":"De l’étude évolutive plateforme FOSTER : Créer une banque d'images pour les futures études radiologiques et radiomiques, du diagnostic à la rechute.","language":34,"languageDescription":"French (France)"},{"id":11153440,"uuid":"a22a41c2-dc0e-4f98-9612-83ac6a2dfd43","attributeTranslation":"Para la plataforma del estudio FOSTER-evolving: Establecer un repositorio de imagen para futuros estudios radiológicos y radiómicos desde diagnóstico hasta recaída.","language":7,"languageDescription":"Spanish"},{"id":11153442,"uuid":"a22a41c2-dc0e-4f98-9612-83ac6a2dfd43","attributeTranslation":"Per lo studio evolutivo della piattaforma FOSTER : Creare un archivio di immagini per futuri studi radiologici e radiomici dalla diagnosi alla recidiva.","language":14,"languageDescription":"Italian"}]},{"id":473645,"number":11,"secondaryObjective":"For FOSTER evolving study platform : To evaluate the prognostic value of imaging and new biological biomarkers from diagnosis to relapse, including, at minimum: -minimally invasive plasma assays (e.g., ctDNA, proteins), -radiomic features of primary tumor MRI at diagnosis and during treatment.","secondaryObjectiveTranslations":[{"id":11153448,"uuid":"d0863c82-efc5-4118-b7e6-ff7cb9f32f53","attributeTranslation":"Para la plataforma del estudio FOSTER-evolving: Evaluar el valor pronóstico de las imágenes y los nuevos biomarcadores biológicos desde el diagnóstico hasta la recaída, como, al menos:\n- tecnologías menos invasivas (dosis plasmáticas; por ejemplo, ctADN, proteínas)\n- características radiómicas de la RMN del tumor primario en el diagnóstico y durante el tratamiento","language":7,"languageDescription":"Spanish"},{"id":11153447,"uuid":"d0863c82-efc5-4118-b7e6-ff7cb9f32f53","attributeTranslation":"Per lo studio evolutivo della piattaforma FOSTER : Analizzare il valore prognostico dell'imaging e dei nuovi biomarcatori biologici dalla diagnosi alla recidiva, inclusi, come minimo: ● analisi plasmatiche minimamente invasive (ad esempio, ctDNA, proteine); ● caratteristiche radiomiche dell'imaging da RM del tumore primario alla diagnosi e durante il trattamento.","language":14,"languageDescription":"Italian"},{"id":11153444,"uuid":"d0863c82-efc5-4118-b7e6-ff7cb9f32f53","attributeTranslation":"W ramach platformy badawczej FOSTER-Evolving : Ocena wartości prognostycznej obrazowania i nowych biomarkerów biologicznych od momentu diagnozy do nawrotu, w tym co najmniej:\n•\tminimalnie inwazyjne badania osocza (np. ctDNA, białka),\n•\tcechy radiomiczne pierwotnego guza w badaniu MRI w momencie diagnozy i podczas leczenia.","language":19,"languageDescription":"Polish"},{"id":11153445,"uuid":"d0863c82-efc5-4118-b7e6-ff7cb9f32f53","attributeTranslation":"De l’étude évolutive plateforme FOSTER : D’évaluer la valeur pronostique de facteurs d’imagerie et de nouveaux biomarqueurs du diagnostic à la rechute, y compris au minimum:\n - les tests plasmatiques mini-invasifs (par exemple ADN ct , proteines)\n - les caractéristiques radiomics de l'IRM de la tumeur primaire au moment du diagnotics et pendant le traitement","language":34,"languageDescription":"French (France)"},{"id":11153446,"uuid":"d0863c82-efc5-4118-b7e6-ff7cb9f32f53","attributeTranslation":"Voor het FOSTER onderzoeksplatform : Het evalueren van de voorspellende waarde van beeldvorming en nieuwe biologische biomarkers van diagnose tot terugval, zoals, tenminste:\n- minimaal invasieve plasma analysen (bijv. ctDNA, eiwitten),\n- radiomische eigenschappen van primaire tumor MRI bij diagnose en tijdens de behandeling","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":473646,"number":12,"secondaryObjective":"For FOSTER evolving study platform : To improve the characterization of lung nodules using artificial intelligence.","secondaryObjectiveTranslations":[{"id":11153449,"uuid":"fe83c75d-dc99-43aa-9a23-572c69b29d66","attributeTranslation":"De l’étude évolutive plateforme FOSTER : Définir la nature des nodules pulmonaires à l’aide de l’intelligence artificielle","language":34,"languageDescription":"French (France)"},{"id":11153452,"uuid":"fe83c75d-dc99-43aa-9a23-572c69b29d66","attributeTranslation":"W ramach platformy badawczej FOSTER-Evolving : Poprawa identyfikacji guzków płucnych przy użyciu sztucznej inteligencji.","language":19,"languageDescription":"Polish"},{"id":11153450,"uuid":"fe83c75d-dc99-43aa-9a23-572c69b29d66","attributeTranslation":"Per lo studio evolutivo della piattaforma FOSTER : Migliorare la caratterizzazione dei noduli polmonari utilizzando l'intelligenza artificiale.","language":14,"languageDescription":"Italian"},{"id":11153451,"uuid":"fe83c75d-dc99-43aa-9a23-572c69b29d66","attributeTranslation":"Voor het FOSTER onderzoeksplatform : Het verbeteren van de karakterisatie van longnodules met behulp van kunstmatige intelligentie","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11153453,"uuid":"fe83c75d-dc99-43aa-9a23-572c69b29d66","attributeTranslation":"Para la plataforma del estudio FOSTER-evolving: Definir mejor la naturaleza de los nódulos pulmonares con ayuda de la inteligencia artificial","language":7,"languageDescription":"Spanish"}]},{"id":473647,"number":13,"secondaryObjective":"For FOSTER evolving study platform : To evaluate the impact of standard treatments on height velocity and growth plate for the pediatric population with persistent potential of growth (Tanner stage 1-2)","secondaryObjectiveTranslations":[{"id":11153458,"uuid":"5d0871bf-412b-469c-a20c-ee7146dbde67","attributeTranslation":"Per lo studio evolutivo della piattaforma FOSTER : Valutare l'impatto dei trattamenti standard sulla velocità di crescita e sulla cartilagine di accrescimento nella popolazione pediatrica con potenziale di crescita persistente (stadio di Tanner 1-2).","language":14,"languageDescription":"Italian"},{"id":11153456,"uuid":"5d0871bf-412b-469c-a20c-ee7146dbde67","attributeTranslation":"De l’étude évolutive plateforme FOSTER : Évaluer l'impact des traitements standard sur la vitesse de croissance et le cartilage de croissance chez les enfants présentant un potentiel de croissance persistant (stade Tanner 1-2).","language":34,"languageDescription":"French (France)"},{"id":11153457,"uuid":"5d0871bf-412b-469c-a20c-ee7146dbde67","attributeTranslation":"Voor het FOSTER onderzoeksplatform : Het evalueren van de impact van standaard zorg op de groeisnelheid en groeischijven bij kinderen met aanhoudend groeipotentieel (Tanner stadium 1 en 2)","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11153454,"uuid":"5d0871bf-412b-469c-a20c-ee7146dbde67","attributeTranslation":"W ramach platformy badawczej FOSTER-Evolving : Ocena wpływu standardowych metod leczenia na tempo wzrostu i chrząstki wzrostowe u dzieci z utrzymującym się potencjałem wzrostu (stopień 1-2 w skali Tannera).","language":19,"languageDescription":"Polish"},{"id":11153455,"uuid":"5d0871bf-412b-469c-a20c-ee7146dbde67","attributeTranslation":"Para la plataforma del estudio FOSTER-evolving: Evaluar el impacto de los tratamientos estándar en la velocidad de crecimiento y la placa de crecimiento en la población pediátrica con potencial de crecimiento persistente (etapa 1-2 de Tanner).","language":7,"languageDescription":"Spanish"}]},{"id":473648,"number":14,"secondaryObjective":"For FOSTER evolving study platform : To implement and compare the impact of more detailed patient-reported outcomes using the Patient-Reported Outcomes Measurement Information System (PROMIS; including pain, anxiety, and fatigue) and the Body Image Scale (BIS).","secondaryObjectiveTranslations":[{"id":11153460,"uuid":"032a19f2-d4e5-4957-973f-cb587d21db26","attributeTranslation":"Per lo studio evolutivo della piattaforma FOSTER : Implementare e confrontare l'impatto di risultati più dettagliati riferiti dai pazienti utilizzando il Patient-Reported Outcomes Measurement Information System (PROMIS; inclusi dolore, ansia e affaticamento) e la Body Image Scale (BIS).","language":14,"languageDescription":"Italian"},{"id":11153459,"uuid":"032a19f2-d4e5-4957-973f-cb587d21db26","attributeTranslation":"Voor het FOSTER onderzoeksplatform : Het implementeren en vergelijken van de impact van een meer gedetailleerde door patiënten gerapporteerde uitkomst, door het gebruik van het Patient-Reported Outcomes Measurement Information System (PROMIS; inclusief pijn, angst en vermoeidheid) en de Body Image Scale (BIS).","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11153461,"uuid":"032a19f2-d4e5-4957-973f-cb587d21db26","attributeTranslation":"De l’étude évolutive plateforme FOSTER : De mettre en œuvre et comparer l'impact de résultats plus détaillés rapportés par les patients à l'aide du système d'information sur la mesure des résultats rapportés par les patients (PROMIS ; incluant la douleur, l'anxiété et la fatigue) et de l'échelle d'image corporelle (BIS).","language":34,"languageDescription":"French (France)"},{"id":11153463,"uuid":"032a19f2-d4e5-4957-973f-cb587d21db26","attributeTranslation":"W ramach platformy badawczej FOSTER-Evolving : Wdrożenie i porównanie wpływu bardziej szczegółowych wyników zgłaszanych przez pacjentów przy użyciu systemu pomiaru wyników zgłaszanych przez pacjentów (PROMIS; w tym ból, lęk i zmęczenie) oraz skali obrazu ciała (BIS).","language":19,"languageDescription":"Polish"},{"id":11153462,"uuid":"032a19f2-d4e5-4957-973f-cb587d21db26","attributeTranslation":"Para la plataforma del estudio FOSTER-evolving: Aplicar y comparar el impacto de un resultado más detallado comunicado por el paciente con el Sistema de Información de Medición de Resultados Comunicados por el Paciente (Patient-Reported Outcomes Measurement Information System, PROMIS) para el dolor, la ansiedad y la fatiga, la Escala de Imagen Corporal (Body Image Scale, BIS) para la imagen corporal.","language":7,"languageDescription":"Spanish"}]},{"id":473649,"number":15,"secondaryObjective":"For FOSTER evolving study platform : To build a broad European collaboration facilitating further collaborative projects.","secondaryObjectiveTranslations":[{"id":11153468,"uuid":"74588b8c-57df-46e3-8d15-863edd61bf02","attributeTranslation":"W ramach platformy badawczej FOSTER-Evolving : Budowa szerokiej współpracy europejskiej ułatwiającej dalsze wspólne projekty.","language":19,"languageDescription":"Polish"},{"id":11153467,"uuid":"74588b8c-57df-46e3-8d15-863edd61bf02","attributeTranslation":"Voor het FOSTER onderzoeksplatform : Een brede Europese samenwerking opbouwen om verdere samenwerkingsprojecten te vergemakkelijken","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11153465,"uuid":"74588b8c-57df-46e3-8d15-863edd61bf02","attributeTranslation":"Para la plataforma del estudio FOSTER-evolving: Crear una amplia colaboración europea que facilite nuevos proyectos de colaboración.","language":7,"languageDescription":"Spanish"},{"id":11153466,"uuid":"74588b8c-57df-46e3-8d15-863edd61bf02","attributeTranslation":"Per lo studio evolutivo della piattaforma FOSTER : Creare un'ampia collaborazione europea che faciliti ulteriori progetti collaborativi.","language":14,"languageDescription":"Italian"},{"id":11153464,"uuid":"74588b8c-57df-46e3-8d15-863edd61bf02","attributeTranslation":"De l’étude évolutive plateforme FOSTER : De mettre en place une collaboration européenne afin de faciliter la mise en place de futurs projets collaboratifs à l’échelle européenne.","language":34,"languageDescription":"French (France)"}]},{"id":473650,"number":16,"secondaryObjective":"For FOSTER-CabOS (first randomization) : To evaluate safety of Cabozantinib, in particular safety when combined with mifamurtide","secondaryObjectiveTranslations":[{"id":11153471,"uuid":"c3e619cf-d597-498a-88e9-1eb424a4b033","attributeTranslation":"Para FOSTER-CabOS (primera aleatorización) : Evaluar la seguridad de cabozantinib, en particular su seguridad cuando se combina con mifamurtida.","language":7,"languageDescription":"Spanish"},{"id":11153472,"uuid":"c3e619cf-d597-498a-88e9-1eb424a4b033","attributeTranslation":"Voor FOSTER-CabOS,(eerste randomisatie) : Evalueren van de veiligheid van cabozantinib, met name de veiligheid in combinatie met mifamurtide","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11153470,"uuid":"c3e619cf-d597-498a-88e9-1eb424a4b033","attributeTranslation":"Pour FOSTER-CabOS (première randomisation) : Evaluer la sécurité du cabozantinib, en particulier lorsqu'il est associé au mifamurtide","language":34,"languageDescription":"French (France)"},{"id":11153473,"uuid":"c3e619cf-d597-498a-88e9-1eb424a4b033","attributeTranslation":"Per FOSTER-CabOS (prima randomizzazione) : valutare la sicurezza di cabozantinib, in particolare la sicurezza quando combinato con mifamurtide","language":14,"languageDescription":"Italian"},{"id":11153469,"uuid":"c3e619cf-d597-498a-88e9-1eb424a4b033","attributeTranslation":"W ramach FOSTER-CabOS (pierwsza randomizacja) : Ocena bezpieczeństwa kabozantynibu, w szczególności jego bezpieczeństwa w skojarzeniu z mifamurtydem.","language":19,"languageDescription":"Polish"}]},{"id":473651,"number":17,"secondaryObjective":"For FOSTER-CabOS (first randomization) : To define the benefit/risk ratio associated with Cabozantinib-versus-control using the Q-TWiST approach (Quality-adjusted Time Without Symptoms of disease recurrence or Toxicity of treatment) and the net treatment benefit, combining efficacy and safety endpoints","secondaryObjectiveTranslations":[{"id":11153474,"uuid":"81be6460-4dbc-48cc-8200-39d5eeeb0a16","attributeTranslation":"Per FOSTER-CabOS (prima randomizzazione) :definire il rapporto rischio/beneficio associato a cabozantinib rispetto al controllo utilizzando l'approccio Q-TWiST (tempo senza sintomi di recidiva di malattia o tossicità del trattamento aggiustato per la qualità) e il beneficio netto del trattamento, combinando endpoint di efficacia e sicurezza","language":14,"languageDescription":"Italian"},{"id":11153475,"uuid":"81be6460-4dbc-48cc-8200-39d5eeeb0a16","attributeTranslation":"Voor FOSTER-CabOS,(eerste randomisatie) : Definieren van het voordeel/risico ratio dat geassocieerd is met cabozantinib versus controle door middel van de QTWIST benadering (Quality-adjusted Time Without Symptoms of disease recurrence or Toxicity of treatment [Voor kwaliteit gecorrigeerde tijd zonder symptomen van terugkeer van de ziekte of toxiciteit van de behandeling]) en het netto behandelingsvoordeel, waarbij werkzaamheid- en veiligheidseindpunten worden gecombineerd","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11153477,"uuid":"81be6460-4dbc-48cc-8200-39d5eeeb0a16","attributeTranslation":"W ramach FOSTER-CabOS (pierwsza randomizacja) : Określenie stosunku korzyści do ryzyka związanego ze stosowaniem kabozantynibu w porównaniu z grupą kontrolną przy użyciu metody Q-TWiST (czas przeżycia skorygowany o jakość życia, wolny od objawów nawrotu choroby i toksyczności leczenia) oraz netto korzyści z leczenia łącząc punkty końcowe dotyczące skuteczności i bezpieczeństwa.","language":19,"languageDescription":"Polish"},{"id":11153476,"uuid":"81be6460-4dbc-48cc-8200-39d5eeeb0a16","attributeTranslation":"Para FOSTER-CabOS (primera aleatorización) : Definir la relación beneficio/riesgo asociada con cabozantinib frente al control utilizando el enfoque Q-TWiST (tiempo ajustado por calidad sin síntomas de recurrencia de la enfermedad o toxicidad del tratamiento) y el beneficio neto del tratamiento, combinando los criterios de valoración de eficacia y seguridad.","language":7,"languageDescription":"Spanish"},{"id":11153478,"uuid":"81be6460-4dbc-48cc-8200-39d5eeeb0a16","attributeTranslation":"Pour FOSTER-CabOS (première randomisation) : Définir le rapport bénéfice/risque associé au cabozantinib par rapport au groupe témoin selon l'approche Q-TWiST (Quality-adjusted Time Without Symptoms of disease recurrence or Toxicity of treatment) et le bénéfice net du traitement, en combinant les critères d'efficacité et de sécurité","language":34,"languageDescription":"French (France)"}]},{"id":473652,"number":18,"secondaryObjective":"For FOSTER-CabOS (first randomization) : To evaluate the prognostic value in terms of EFS of various clinical, radiological and biological factors, as well as their predictive value, i.e to define whether the treatment effect of Cabozantinib on EFS differs between subgroups of patients (disease status, histological response of the primary tumour; biological subgroups in particular G1/G2 diagnostic RNAseq signature; type of first line chemotherapy; use of mifamurtide ; age, metastatic status at diagnosis)) Note that the determination of G1/G2 signature requires the implementation of biology sample collections of the primary tumour.","secondaryObjectiveTranslations":[{"id":11153480,"uuid":"9579fb36-6ec8-40a5-ac13-f57009deef40","attributeTranslation":"W ramach FOSTER-CabOS (pierwsza randomizacja) : Ocena wartości prognostycznej różnych czynników klinicznych, radiologicznych i biologicznych w odniesieniu do EFS oraz ich wartości predykcyjnej, tj. określenie, czy efekt leczenia kabozantynibem w odniesieniu do EFS różni się pomiędzy podgrupami pacjentów ( stan choroby i odpowiedź histologiczną; podgrupy biologiczne, w szczególności sygnatura RNAseq G1/G2; rodzaj chemioterapii pierwszego rzutu; zastosowanie mifamurtydu; wiek, obecność przerzutów w momencie rozpoznania).\nNależy zaznaczyć, że określenie sygnatury G1/G2 wymaga pobrania próbek biologicznych z guza pierwotnego.","language":19,"languageDescription":"Polish"},{"id":11153483,"uuid":"9579fb36-6ec8-40a5-ac13-f57009deef40","attributeTranslation":"Per FOSTER-CabOS (prima randomizzazione) : valutare il valore prognostico in termini di EFS di vari fattori clinici, radiologici e biologici, nonché il loro valore predittivo, per definire se l'effetto del trattamento di cabozantinib sull'EFS differisce tra sottogruppi di pazienti ( stato della malattia, risposta istologica del tumore primario; sottogruppi biologici in particolare la firma diagnostica di RNAseq G1/G2; tipo di chemioterapia di prima linea; uso di mifamurtide; età, stato metastatico alla diagnosi). \nSi noti che la determinazione della firma G1/G2 richiede l'implementazione di raccolte di campioni biologici del tumore primario;","language":14,"languageDescription":"Italian"},{"id":11153481,"uuid":"9579fb36-6ec8-40a5-ac13-f57009deef40","attributeTranslation":"Pour FOSTER-CabOS (première randomisation) : D’évaluer la valeur pronostique en terme de SSE des différents facteurs cliniques, radiologiques et facteurs biologiques, ainsi que la valeur prédictive, par exemple : D’évaluer si l'effet du cabozantinib sur la SSE diffère entre les sous-groupes de patients (statut de la maladie, réponse histologique de la tumeur primaire, sous groupe biologique en particulier la signature G1/G2 par RNAseq ; type de chimiothérapie de première ligne, utilisation de mifamurtide (age, statut métastatique au diagnostic).\nA noter que la détermination de la signature G1/G2 requiert l’implémentation des prélèvements biologiques de la tumeur primaire.","language":34,"languageDescription":"French (France)"},{"id":11153482,"uuid":"9579fb36-6ec8-40a5-ac13-f57009deef40","attributeTranslation":"Voor FOSTER-CabOS,(eerste randomisatie) : Evalueren van de prognostische waarde in termen van EFS van verschillende klinische, radiologische en biologische factoren, als ook hun voorspellende waarde, d.w.z. definieren of het effect van behandeling met cabozantinib op EFS verschilt tussen de subgroepen patiënten ( ziektesstatus , histologische response van de primaire tumor; biologische subgroepen in met name G1/G2 diagnostische RNAseq signatuur; type eerstelijns chemotherapie; gebruik van mifamurtide: leeftijd, aanwezigheid van uitzaaiingen bij de diagnose). Merk op dat er voor de bepaling van de G1/G2 signatuur, de implementatie van het verzamelen van de biologische lichaamsmaterialen van de primaire tumor ten tijde van de diagnose nodig is.","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11153479,"uuid":"9579fb36-6ec8-40a5-ac13-f57009deef40","attributeTranslation":"Para FOSTER-CabOS (primera aleatorización) : Evaluar el valor pronóstico en términos de EFS de diversos factores clínicos, radiológicos y biológicos, así como su valor predictivo, es decir, definir si el efecto del tratamiento con cabozantinib sobre la EFS difiere entre los subgrupos de pacientes estado de la enfermedad, de la la respuesta histológica del tumor primario; subgrupos biológicos, en particular la firma diagnóstica G1/G2 de RNAseq; tipo de quimioterapia de primera línea; uso de mifamurtida; edad y estado metastásico en el momento del diagnóstico). Cabe señalar que la determinación de la firma G1/G2 requiere la recogida de muestras biológicas del tumor primario.","language":7,"languageDescription":"Spanish"}]},{"id":473653,"number":19,"secondaryObjective":"For FOSTER-CabOS (first randomization) : To evaluate wether cabozantnib affects the longitudinal growth in Pediatric population .","secondaryObjectiveTranslations":[{"id":11153486,"uuid":"1c8ca700-71c5-4547-b24e-571a6ecf9f31","attributeTranslation":"Voor FOSTER-CabOS,(eerste randomisatie) : Evalueren of cabozantinib de groeisnelheid bij kinderen beinvloed","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11153485,"uuid":"1c8ca700-71c5-4547-b24e-571a6ecf9f31","attributeTranslation":"Pour FOSTER-CabOS (première randomisation) : Évaluer si le cabozantinib affecte la croissance longitudinale dans la population pédiatrique.","language":34,"languageDescription":"French (France)"},{"id":11153484,"uuid":"1c8ca700-71c5-4547-b24e-571a6ecf9f31","attributeTranslation":"W ramach FOSTER-CabOS (pierwsza randomizacja) : Ocena, czy kabozantynib wpływa na przyrost długości/wysokości w populacji pediatrycznej.","language":19,"languageDescription":"Polish"},{"id":11153488,"uuid":"1c8ca700-71c5-4547-b24e-571a6ecf9f31","attributeTranslation":"Per FOSTER-CabOS (prima randomizzazione) : valutare se cabozantinib influisce sulla crescita longitudinale nella popolazione pediatrica","language":14,"languageDescription":"Italian"},{"id":11153487,"uuid":"1c8ca700-71c5-4547-b24e-571a6ecf9f31","attributeTranslation":"Para FOSTER-CabOS (primera aleatorización) : Evaluar si el cabozantinib afecta al crecimiento longitudinal en la población pediátrica.","language":7,"languageDescription":"Spanish"}]},{"id":473654,"number":20,"secondaryObjective":"For FOSTER-CabOS (first randomization) : To evaluate the impact of Cabozantinib vs BSC on surgical procedures wound healing and postoperative complications rates.","secondaryObjectiveTranslations":[{"id":11153489,"uuid":"b3fbf478-8ce0-4917-995d-eb0fab788448","attributeTranslation":"Para FOSTER-CabOS (primera aleatorización) : Evaluar el impacto del cabozantinib frente al BSC en los procedimientos quirúrgicos, la cicatrización de heridas y las tasas de complicaciones postoperatorias.","language":7,"languageDescription":"Spanish"},{"id":11153493,"uuid":"b3fbf478-8ce0-4917-995d-eb0fab788448","attributeTranslation":"W ramach FOSTER-CabOS (pierwsza randomizacja) : Ocena wpływu kabozantynibu w porównaniu z BSC na gojenie ran po zabiegach chirurgicznych oraz częstość powikłań pooperacyjnych.","language":19,"languageDescription":"Polish"},{"id":11153491,"uuid":"b3fbf478-8ce0-4917-995d-eb0fab788448","attributeTranslation":"Per FOSTER-CabOS (prima randomizzazione) : valutare l'impatto di cabozantinib rispetto a BSC sulla guarigione delle ferite chirurgiche e sui tassi di complicanze postoperatorie.","language":14,"languageDescription":"Italian"},{"id":11153490,"uuid":"b3fbf478-8ce0-4917-995d-eb0fab788448","attributeTranslation":"Pour FOSTER-CabOS (première randomisation) : D’évaluer l’impact du cabozantinib versus soins de support sur les procédures chirurgicales, la cicatrisation des plaies et les taux de complications post-opératoires.","language":34,"languageDescription":"French (France)"},{"id":11153492,"uuid":"b3fbf478-8ce0-4917-995d-eb0fab788448","attributeTranslation":"Voor FOSTER-CabOS,(eerste randomisatie) : Evalueren van de impact van cabozantinib in vergelijking met de beste standaardzorg op de wondgenezing van chirurgische procedures en postoperatieve complicaties.","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":473655,"number":21,"secondaryObjective":"For FOSTER-CabOS (first randomization) : To evaluate the efficacy/resistance to cabozantinib compared to the best supportive care according to G1/G2 diagnostic RNAseq signature","secondaryObjectiveTranslations":[{"id":11153497,"uuid":"eceb687e-ca4e-4fae-8bee-2a07739648f3","attributeTranslation":"Pour FOSTER-CabOS (première randomisation) : Evaluer l'efficacité/la résistance au cabozantinib par rapport aux soins de support selon la signature diagnostique RNAseq G1/G2","language":34,"languageDescription":"French (France)"},{"id":11153498,"uuid":"eceb687e-ca4e-4fae-8bee-2a07739648f3","attributeTranslation":"Per FOSTER-CabOS (prima randomizzazione) :valutare l'efficacia/resistenza a cabozantinib rispetto alla migliore terapia di supporto in base alla firma diagnostica RNAseq G1/G2","language":14,"languageDescription":"Italian"},{"id":11153494,"uuid":"eceb687e-ca4e-4fae-8bee-2a07739648f3","attributeTranslation":"Para FOSTER-CabOS (primera aleatorización) : Evaluar la eficacia/resistencia al cabozantinib en comparación con el mejor tratamiento de apoyo según la firma diagnóstica G1/G2 de secuenciación del ARN.","language":7,"languageDescription":"Spanish"},{"id":11153495,"uuid":"eceb687e-ca4e-4fae-8bee-2a07739648f3","attributeTranslation":"Voor FOSTER-CabOS,(eerste randomisatie) : Evalueren van de werkzaamheid/resistentie tegen cabozantinib in vergelijking met beste standaard zorg volgens G1/G2 diagnostische RNAseq signatuur","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11153496,"uuid":"eceb687e-ca4e-4fae-8bee-2a07739648f3","attributeTranslation":"W ramach FOSTER-CabOS (pierwsza randomizacja) : Ocena skuteczności/oporności na kabozantynib w porównaniu ze standardową opieką medyczną (BSC) zgodnie z sygnaturą RNAseq G1/G2.","language":19,"languageDescription":"Polish"}]},{"id":473656,"number":22,"secondaryObjective":"For FOSTER-CabOS (first randomization) : to define the role of ctDNA follow-up as a predictive biomarker of efficacy/ resistance of cabozantinib compared the best supportive care","secondaryObjectiveTranslations":[{"id":11153500,"uuid":"1f75cc65-b8f5-4129-8d05-59a1f5600db7","attributeTranslation":"Pour FOSTER-CabOS (première randomisation) : définir le rôle du suivi du ctDNA en tant que biomarqueur prédictif de l'efficacité/la résistance au cabozantinib par rapport aux soins de support","language":34,"languageDescription":"French (France)"},{"id":11153502,"uuid":"1f75cc65-b8f5-4129-8d05-59a1f5600db7","attributeTranslation":"Para FOSTER-CabOS (primera aleatorización) : Definir el papel del seguimiento del ADN libre circulante como biomarcador predictivo de la eficacia/resistencia al cabozantinib en comparación con el mejor tratamiento de apoyo.","language":7,"languageDescription":"Spanish"},{"id":11153499,"uuid":"1f75cc65-b8f5-4129-8d05-59a1f5600db7","attributeTranslation":"Per FOSTER-CabOS (prima randomizzazione) : definire il ruolo del follow-up del ctDNA come biomarcatore predittivo dell'efficacia/resistenza al cabozantinib rispetto alla migliore terapia di supporto","language":14,"languageDescription":"Italian"},{"id":11153501,"uuid":"1f75cc65-b8f5-4129-8d05-59a1f5600db7","attributeTranslation":"W ramach FOSTER-CabOS (pierwsza randomizacja) : Określenie roli monitorowania ctDNA jako biomarkera predykcyjnego skuteczności/oporności na kabozantynib w porównaniu z BSC.","language":19,"languageDescription":"Polish"},{"id":11153503,"uuid":"1f75cc65-b8f5-4129-8d05-59a1f5600db7","attributeTranslation":"Voor FOSTER-CabOS,(eerste randomisatie) : Definieren van de rol van ctDNA follow-up als voorspellende biomarker van werkzaamheid/resistentie van cabozantinib in vergelijking met beste standaard zorg","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":473657,"number":23,"secondaryObjective":"For FOSTER-CabOS (first randomization) : to identify Tumor and TME resistance phenotype to cabozantinib by comparing tumour at diagnosis and at relapse","secondaryObjectiveTranslations":[{"id":11153505,"uuid":"9eadbd13-7436-47a1-b3ca-bef5c8aa071e","attributeTranslation":"Pour FOSTER-CabOS (première randomisation) : identifier le phénotype de résistance de la tumeur et du TME au cabozantinib en comparant la tumeur au moment du diagnostic et au moment de la rechute.","language":34,"languageDescription":"French (France)"},{"id":11153507,"uuid":"9eadbd13-7436-47a1-b3ca-bef5c8aa071e","attributeTranslation":"Para FOSTER-CabOS (primera aleatorización) : Identificar el fenotipo de resistencia del tumor y del microambiente tumoral al cabozantinib comparando el tumor en el momento del diagnóstico y en el momento de la recaída.","language":7,"languageDescription":"Spanish"},{"id":11153504,"uuid":"9eadbd13-7436-47a1-b3ca-bef5c8aa071e","attributeTranslation":"Voor FOSTER-CabOS,(eerste randomisatie) : Tumor- en TME-resistentiefenotype tegen cabozantinib identificeren door tumor bij diagnose en bij terugval te vergelijken","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11153506,"uuid":"9eadbd13-7436-47a1-b3ca-bef5c8aa071e","attributeTranslation":"W ramach FOSTER-CabOS (pierwsza randomizacja) : Identyfikacja fenotypu oporności guza i TME na kabozantynib poprzez porównanie guza w momencie rozpoznania i nawrotu choroby.","language":19,"languageDescription":"Polish"},{"id":11153508,"uuid":"9eadbd13-7436-47a1-b3ca-bef5c8aa071e","attributeTranslation":"Per FOSTER-CabOS (prima randomizzazione) : identificare il fenotipo di resistenza del tumore e della microambiente tumorale (TME) al cabozantinib confrontando il tumore alla diagnosi e alla recidiva","language":14,"languageDescription":"Italian"}]},{"id":474080,"number":24,"secondaryObjective":"For FOSTER-CabOS (first randomization) : to evaluate whether the cabozantinib affects the growth plate maturation and morphology","secondaryObjectiveTranslations":[{"id":11169438,"uuid":"5069e227-8bd8-42b8-992b-8a9009e16594","attributeTranslation":"Per FOSTER-CabOS (prima randomizzazione) : valutare se cabozantinib influisce sulla maturazione e sulla morfologia della cartilagine di accrescimento;","language":14,"languageDescription":"Italian"},{"id":11169436,"uuid":"5069e227-8bd8-42b8-992b-8a9009e16594","attributeTranslation":"Voor FOSTER-CabOS(eerste randomisatie) : om te onderzoeken of cabozantinib invloed heeft op de rijping en morfologie van de groeischijf","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11169437,"uuid":"5069e227-8bd8-42b8-992b-8a9009e16594","attributeTranslation":"W ramach FOSTER-CabOS (pierwsza randomizacja) : Ocena,\tczy\tkabozantynib\twpływa\tna dojrzewanie i morfologię chrząstki wzrostowej.","language":19,"languageDescription":"Polish"},{"id":11169435,"uuid":"5069e227-8bd8-42b8-992b-8a9009e16594","attributeTranslation":"Para FOSTER-CabOS (primera aleatorización) : Evaluar si el cabozantinib afecta a la maduración y la morfología de la placa de crecimiento.","language":7,"languageDescription":"Spanish"},{"id":11169434,"uuid":"5069e227-8bd8-42b8-992b-8a9009e16594","attributeTranslation":"Pour FOSTER-CabOS (première randomisation) : déterminer si le cabozantinib a une incidence sur la maturation et la morphologie du cartilage de croissance","language":34,"languageDescription":"French (France)"}]},{"id":474089,"number":25,"secondaryObjective":"For FOSTER-CabOS (first randomization) : to evaluate whether the cabozantinib affects growth biology.","secondaryObjectiveTranslations":[{"id":11169505,"uuid":"e1e04083-bbd5-4ce9-9be7-51754e0ff334","attributeTranslation":"Voor FOSTER-CabOS(eerste randomisatie) : om te onderzoeken of cabozantinib invloed heeft op de groeibiologie.","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11169506,"uuid":"e1e04083-bbd5-4ce9-9be7-51754e0ff334","attributeTranslation":"W ramach FOSTER-CabOS (pierwsza randomizacja) : Ocena, czy kabozantynib wpływa na biologię wzrostu.","language":19,"languageDescription":"Polish"},{"id":11169503,"uuid":"e1e04083-bbd5-4ce9-9be7-51754e0ff334","attributeTranslation":"Pour FOSTER-CabOS (première randomisation) : déterminer si le cabozantinib a une incidence sur la biologie de la croissance.","language":34,"languageDescription":"French (France)"},{"id":11169507,"uuid":"e1e04083-bbd5-4ce9-9be7-51754e0ff334","attributeTranslation":"Per FOSTER-CabOS (prima randomizzazione) : valutare se cabozantinib influisce sulla biologia della crescita.","language":14,"languageDescription":"Italian"},{"id":11169504,"uuid":"e1e04083-bbd5-4ce9-9be7-51754e0ff334","attributeTranslation":"Para FOSTER-CabOS (primera aleatorización) : Evaluar si el cabozantinib afecta a la biología del crecimiento.","language":7,"languageDescription":"Spanish"}]}]},"eligibilityCriteria":{"principalInclusionCriteria":[{"id":903257,"number":1,"principalInclusionCriteria":"For FOSTER evolving study platform - 1. Newly diagnosed, biopsy-proven, high-grade osteosarcoma","principalInclusionCriteriaTranslations":[{"id":11153280,"uuid":"45528205-9785-4964-8ce4-a610f5f5768c","attributeTranslation":"W ramach badania FOSTER - 1. Nowo zdiagnozowany, potwierdzony biopsją, kostniakomięsak o wysokim stopniu złośliwości","language":19,"languageDescription":"Polish"},{"id":11153279,"uuid":"45528205-9785-4964-8ce4-a610f5f5768c","attributeTranslation":"1. De l’étude évolutive plateforme FOSTER : Ostéosarcome de haut grade ou à petites cellules nouvellement diagnostiqué et confirmé par biopsie","language":34,"languageDescription":"French (France)"},{"id":11153281,"uuid":"45528205-9785-4964-8ce4-a610f5f5768c","attributeTranslation":"Para la plataforma del estudio FOSTER-evolving - 1. Osteosarcoma de alto grado recién diagnosticado y probado mediante biopsia","language":7,"languageDescription":"Spanish"},{"id":11153283,"uuid":"45528205-9785-4964-8ce4-a610f5f5768c","attributeTranslation":"Per lo studio evolutivo della piattaforma FOSTER - 1. Osteosarcoma di alto grado di nuova diagnosi, confermato da biopsia.","language":14,"languageDescription":"Italian"},{"id":11153282,"uuid":"45528205-9785-4964-8ce4-a610f5f5768c","attributeTranslation":"Voor het FOSTER onderzoeksplatfom - 1. Nieuw gediagnosticeerd hooggradig osteosarcoom, bevestigd door middel van een biopsie","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":903258,"number":10,"principalInclusionCriteria":"For FOSTER-CabOS (first randomization) - 5. Performance status < 2 for patient adult, or >70 using Karnofsky or Lansky performance scores.","principalInclusionCriteriaTranslations":[{"id":11153284,"uuid":"af50d86c-ed08-42fe-a781-fbbee95ac011","attributeTranslation":"Per FOSTER-CabOS (prima randomizzazione) - 5. Stato di performance < 2 per il paziente adulto o > 70 utilizzando i punteggi di performance di Karnofsky o Lansky.","language":14,"languageDescription":"Italian"},{"id":11153287,"uuid":"af50d86c-ed08-42fe-a781-fbbee95ac011","attributeTranslation":"W ramach FOSTER-CabOS (pierwsza randomizacja) - 5. Stan ogólny: < 2 dla pacjenta dorosłego lub > 70 według skali Karnofsky'ego lub Lansky'ego.","language":19,"languageDescription":"Polish"},{"id":11153288,"uuid":"af50d86c-ed08-42fe-a781-fbbee95ac011","attributeTranslation":"Voor FOSTER-CabOS,(eerste randomisatie) - 5. Prestatiestatus < 2 voor volwassen patiënt, of > 70 bij gebruik van Karnofsky- of Lansky-prestatiescores.","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11153285,"uuid":"af50d86c-ed08-42fe-a781-fbbee95ac011","attributeTranslation":"Pour FOSTER-CabOS (première randomisation) - 5. Indice de performance < 2 pour les patients adultes, ou > 70 selon les scores de performance de Karnofsky ou Lansky.","language":34,"languageDescription":"French (France)"},{"id":11153286,"uuid":"af50d86c-ed08-42fe-a781-fbbee95ac011","attributeTranslation":"Para FOSTER-CabOS (primera aleatorización) - 5. Estado funcional < 2 para pacientes adultos, o > 70 según las puntuaciones de Karnofsky o Lansky.","language":7,"languageDescription":"Spanish"}]},{"id":903259,"number":11,"principalInclusionCriteria":"For FOSTER-CabOS (first randomization) - 6. Interval between the last treatment either chemotherapy administration or surgical procedures or radiotherapy or thermoablation, (whichever occurred last) and the date of randomisation should be at least 4 weeks but no longer than 2 months","principalInclusionCriteriaTranslations":[{"id":11153289,"uuid":"f308e954-a680-42ef-bdbf-b3dc3368b353","attributeTranslation":"Voor FOSTER-CabOS,(eerste randomisatie) - 6. Het interval tussen de laatste behandeling, hetzij toediening van chemotherapie of chirurgische ingrepen, hetzij bestraling van de primaire tumor (afhankelijk van welke behandeling het laatst heeft plaatsgevonden) en de datum van randomisatie moet ten minste 4 weken, maar niet langer dan 2 maanden zijn;","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11153293,"uuid":"f308e954-a680-42ef-bdbf-b3dc3368b353","attributeTranslation":"W ramach FOSTER-CabOS (pierwsza randomizacja) - 6. Odstęp między ostatnim leczeniem – chemioterapią, zabiegami chirurgicznymi, radioterapią lub termoablacją (w zależności od tego, które wystąpiło jako ostatnie) – a datą randomizacji powinien wynosić co najmniej 4 tygodnie, ale nie więcej niż 2 miesiące;","language":19,"languageDescription":"Polish"},{"id":11153291,"uuid":"f308e954-a680-42ef-bdbf-b3dc3368b353","attributeTranslation":"Per FOSTER-CabOS (prima randomizzazione) - 6. L'intervallo tra l'ultimo trattamento, sia esso di chemioterapia, intervento chirurgico, radioterapia o termoablazione (a seconda di quale si sia verificato per ultimo) e la data di randomizzazione deve essere di almeno 4 settimane ma non superiore a 2 mesi.","language":14,"languageDescription":"Italian"},{"id":11153292,"uuid":"f308e954-a680-42ef-bdbf-b3dc3368b353","attributeTranslation":"Para FOSTER-CabOS (primera aleatorización) - 6. El intervalo entre el último tratamiento, ya sea la administración de quimioterapia, procedimientos quirúrgicos, radioterapia o termoablación (lo que haya ocurrido en último lugar) y la fecha de aleatorización debe ser de al menos 4 semanas, pero no más de 2 meses.","language":7,"languageDescription":"Spanish"},{"id":11153290,"uuid":"f308e954-a680-42ef-bdbf-b3dc3368b353","attributeTranslation":"Pour FOSTER-CabOS (première randomisation) - 6. L'intervalle entre le dernier traitement, qu'il s'agisse d'une chimiothérapie, d'une intervention chirurgicale, d'une radiothérapie ou d'une thermoablation (selon la dernière intervention effectuée), et la date de randomisation doit être d'au moins 4 semaines, mais ne doit pas dépasser 2 mois.","language":34,"languageDescription":"French (France)"}]},{"id":903260,"number":12,"principalInclusionCriteria":"For FOSTER-CabOS (first randomization) - 7. Disease in complete remission or with residual persistent stable disease according to RECIST criteria before randomisation (please refer 7.3.4 for the definition of the residual persistent stable disease)","principalInclusionCriteriaTranslations":[{"id":11153298,"uuid":"a05f9a56-eb63-4a2e-835b-2d97530a1e04","attributeTranslation":"Para FOSTER-CabOS (primera aleatorización) -7. Enfermedad en remisión completa o con enfermedad residual persistente estable según los criterios RECIST antes de la aleatorización. (véase el apartado 7.3.4 para la definición de «enfermedad residual persistente estable»)","language":7,"languageDescription":"Spanish"},{"id":11153295,"uuid":"a05f9a56-eb63-4a2e-835b-2d97530a1e04","attributeTranslation":"Pour FOSTER-CabOS (première randomisation) - 7. Maladie en rémission complète ou maladie résiduelle persistante et stable selon les critères RECIST avant la randomisation (merci de vous référer à la section 7.3.4 pour la définition de maladie résiduelle persistante et stable).","language":34,"languageDescription":"French (France)"},{"id":11153297,"uuid":"a05f9a56-eb63-4a2e-835b-2d97530a1e04","attributeTranslation":"W ramach FOSTER-CabOS (pierwsza randomizacja) - 7. Choroba w całkowitej remisji lub choroba w fazie stabilnej z resztkowymi ogniskami zgodnie z kryteriami RECIST przed randomizacją (definicja resztkowej, utrzymującej się stabilnej choroby znajduje się w punkcie 7.3.4)","language":19,"languageDescription":"Polish"},{"id":11153296,"uuid":"a05f9a56-eb63-4a2e-835b-2d97530a1e04","attributeTranslation":"Voor FOSTER-CabOS,(eerste randomisatie) - 7. Ziekte in volledige remissie of met resterende, aanhoudende, stabiele ziekte volgens RECIST-criteria vóór de randomisatie (zie paragraaf 7.3.4 voor de definitie van de resterende, aanhoudende, stabiele ziekte)","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11153294,"uuid":"a05f9a56-eb63-4a2e-835b-2d97530a1e04","attributeTranslation":"Per FOSTER-CabOS (prima randomizzazione) - 7. Malattia in remissione completa o con malattia residua stabile e persisrenrte secondo i criteri RECIST prima della randomizzazione (per la definizione di «malattia residua stabile e persistente», si veda il punto 7.3.4).","language":14,"languageDescription":"Italian"}]},{"id":903261,"number":13,"principalInclusionCriteria":"For FOSTER-CabOS (first randomization) - 8. Patient fit to undergo protocol treatment and follow-up","principalInclusionCriteriaTranslations":[{"id":11153300,"uuid":"67efa9a8-2ed0-4227-b708-bd43fc5a8e78","attributeTranslation":"Para FOSTER-CabOS (primera aleatorización) - 8. Paciente apto para someterse al tratamiento del protocolo y al seguimiento.","language":7,"languageDescription":"Spanish"},{"id":11153299,"uuid":"67efa9a8-2ed0-4227-b708-bd43fc5a8e78","attributeTranslation":"W ramach FOSTER-CabOS (pierwsza randomizacja) - 8. Pacjent kwalifikujący się do leczenia i obserwacji zgodnie z protokołem","language":19,"languageDescription":"Polish"},{"id":11153303,"uuid":"67efa9a8-2ed0-4227-b708-bd43fc5a8e78","attributeTranslation":"Per FOSTER-CabOS (prima randomizzazione) - 8. Paziente idoneo a sottoporsi al trattamento del protocollo e al follow-up.","language":14,"languageDescription":"Italian"},{"id":11153302,"uuid":"67efa9a8-2ed0-4227-b708-bd43fc5a8e78","attributeTranslation":"Voor FOSTER-CabOS,(eerste randomisatie) - 8. Patiënt geschikt voor protocollaire behandeling en follow-up","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11153301,"uuid":"67efa9a8-2ed0-4227-b708-bd43fc5a8e78","attributeTranslation":"Pour FOSTER-CabOS (première randomisation) - 8. Patient apte à suivre le traitement et le suivi prévus par le protocole.","language":34,"languageDescription":"French (France)"}]},{"id":903262,"number":14,"principalInclusionCriteria":"For FOSTER-CabOS (first randomization) -9. Adequate cardiac function: Left Ventricular Ejection Fraction (LVEF) ≥50% and/or fractional shortening (FS) >28% at baseline as determined by echocardiography or multigated acquisition (MUGA) scan (performed only if echocardiography is not feasible)","principalInclusionCriteriaTranslations":[{"id":11153305,"uuid":"843ed05a-e98b-4d60-8c28-bc1c1947846e","attributeTranslation":"Per FOSTER-CabOS (prima randomizzazione) -9. Funzione cardiaca adeguata: frazione di eiezione ventricolare sinistra (LVEF) ≥50% e/o accorciamento frazionale (FS) >28% al basale come determinato dall'ecocardiografia o acquisizione in scansione multigated (MUGA) (da eseguire solo se non è possibile effettuare un'ecocardiografia)","language":14,"languageDescription":"Italian"},{"id":11153306,"uuid":"843ed05a-e98b-4d60-8c28-bc1c1947846e","attributeTranslation":"Voor FOSTER-CabOS,(eerste randomisatie) - 9. Adequate hartfunctie: Linkerventrikel ejectiefractie (LVEF) ≥50% en/of fractionele verkorting (FS) >28% bij baseline zoals bepaald door echocardiografie of multigated acquisitie (MUGA) scan. (wordt alleen uitgevoerd als echocardiografie niet mogelijk is)","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11153307,"uuid":"843ed05a-e98b-4d60-8c28-bc1c1947846e","attributeTranslation":"W ramach FOSTER-CabOS (pierwsza randomizacja) - 9. Prawidłowa czynność serca: frakcja wyrzutowa lewej komory (LVEF) ≥50% i/lub frakcja skracania (FS) >28% w badaniu wyjściowym, ocenione w echokardiografii lub badaniu MUGA (wykonywane wyłącznie w przypadku, gdy nie ma możliwości wykonania badania echokardiograficznego)","language":19,"languageDescription":"Polish"},{"id":11153304,"uuid":"843ed05a-e98b-4d60-8c28-bc1c1947846e","attributeTranslation":"Pour FOSTER-CabOS (première randomisation) - 9. Fonction cardiaque adéquate : fraction d'éjection ventriculaire gauche (FEVG) ≥ 50 % et/ou fraction de raccourcissement (FR) > 28 % au départ, telle que déterminée par échocardiographie ou par scintigraphie multigated acquisition (MUGA) (réalisé seulement si l'échocardiographie n'est pas faisable).","language":34,"languageDescription":"French (France)"},{"id":11153308,"uuid":"843ed05a-e98b-4d60-8c28-bc1c1947846e","attributeTranslation":"Para FOSTER-CabOS (primera aleatorización) - 9. Función cardíaca adecuada: fracción de eyección del ventrículo izquierdo (FEVI) ≥50 % y/o acortamiento fraccional (AF) >28 % en la línea de base, según lo determinado por ecocardiografía o gammagrafía multigated (MUGA).(performed only if echocardiography is not feasible)","language":7,"languageDescription":"Spanish"}]},{"id":903263,"number":15,"principalInclusionCriteria":"For FOSTER-CabOS (first randomization) - 10. Adequately controlled blood pressure (BP) with or without antihypertensive medications: BP 95th percentile for sex, age and height/length at screening (as per NHLBI (National Heart, Lung and Blood Institute) guidelines) and no change in antihypertensive medications within 1 week prior to start of treatment (C1D1). Patients aged >18 years should have a BP ≤150/90 mmHg at screening and no change in antihypertensive therapy within 1 week prior to C1D1","principalInclusionCriteriaTranslations":[{"id":11153313,"uuid":"31c068fc-ea3f-4d3d-b363-b83d0117f214","attributeTranslation":"W ramach FOSTER-CabOS (pierwsza randomizacja) - 10. Odpowiednio kontrolowane ciśnienie krwi (BP) z lub bez leków przeciwnadciśnieniowych: BP 95. percentyl dla płci, wieku i wzrostu/długości w momencie badania przesiewowego (zgodnie z wytycznymi NHLBI (National Heart, Lung and Blood Institute)) i brak zmian w przyjmowaniu leków przeciwnadciśnieniowych w ciągu 1 tygodnia przed rozpoczęciem leczenia (C1D1). Pacjenci w wieku >18 lat powinni mieć ciśnienie krwi ≤150/90 mmHg podczas badania przesiewowego i brak zmian w leczeniu przeciwnadciśnieniowym w ciągu 1 tygodnia przed C1D1.","language":19,"languageDescription":"Polish"},{"id":11153311,"uuid":"31c068fc-ea3f-4d3d-b363-b83d0117f214","attributeTranslation":"Voor FOSTER-CabOS,(eerste randomisatie) - 10. Adequaat gecontroleerde bloeddruk (BP) met of zonder antihypertensiva: BP 95e percentiel voor geslacht, leeftijd en lengte/lengte bij screening (volgens NHLBI-richtlijnen (National Heart, Lung and Blood Institute)) en geen verandering in antihypertensieve medicatie binnen 1 week voor aanvang van de behandeling (C1D1). Patiënten ouder dan 18 jaar moeten een bloeddruk ≤150/90 mmHg hebben bij de screening en geen verandering in antihypertensieve behandeling binnen 1 week voorafgaand aan C1D1.","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11153309,"uuid":"31c068fc-ea3f-4d3d-b363-b83d0117f214","attributeTranslation":"Para FOSTER-CabOS (primera aleatorización) - 10. Presión arterial (PA) adecuadamente controlada con o sin medicamentos antihipertensivos: PA en el percentil 95 para el sexo, la edad y la altura/longitud en la selección (según las directrices del NHLBI [Instituto Nacional del Corazón, los Pulmones y la Sangre]) y sin cambios en los medicamentos antihipertensivos en la semana anterior al inicio del tratamiento (C1D1). Los pacientes mayores de 18 años deben tener una PA ≤ 150/90 mmHg en la selección y no haber cambiado la terapia antihipertensiva en la semana anterior al C1D1.","language":7,"languageDescription":"Spanish"},{"id":11153310,"uuid":"31c068fc-ea3f-4d3d-b363-b83d0117f214","attributeTranslation":"Per FOSTER-CabOS (prima randomizzazione) - 10. Pressione arteriosa (PA) adeguatamente controllata con o senza farmaci antipertensivi: PA 95° percentile per sesso, età e altezza/lunghezza allo screening (secondo le linee guida NHLBI (National Heart, Lung and Blood Institute)) e nessuna modifica dei farmaci antipertensivi entro 1 settimana prima dell'inizio del trattamento (C1D1). I pazienti di età > 18 anni devono avere una PA ≤ 150/90 mmHg allo screening e nessuna modifica della terapia antipertensiva entro 1 settimana prima di C1D1.","language":14,"languageDescription":"Italian"},{"id":11153312,"uuid":"31c068fc-ea3f-4d3d-b363-b83d0117f214","attributeTranslation":"Pour FOSTER-CabOS (première randomisation) - 10. Tension artérielle (TA) correctement contrôlée avec ou sans médicaments antihypertenseurs : TA au 95e percentile pour le sexe, l'âge et la taille/longueur lors de la sélection (conformément aux directives du NHLBI (National Heart, Lung and Blood Institute)) et aucun changement dans les médicaments antihypertenseurs dans la semaine précédant le début du traitement (C1D1). Les patients âgés de plus de 18 ans doivent avoir une PA ≤ 150/90 mmHg lors du dépistage et aucun changement dans le traitement antihypertenseur dans la semaine précédant le C1D1.","language":34,"languageDescription":"French (France)"}]},{"id":903264,"number":16,"principalInclusionCriteria":"For FOSTER-CabOS (first randomization) - 11. Screening laboratory values must meet the following criteria (according to CTCAE v5) and should be obtained within 7 days prior to randomisation - Absolute neutrophil count ≥ 1 x 109/L - Platelets ≥ 100 x 109/L - Haemoglobin ≥ 8.0 g/dL (a hemoglobin of less than 8.0 g/dl is acceptable if it is corrected by growth factor or transfusion before C1D1) - Serum creatinine ≤ 1.5 x ULN or based on age/gender. If serum creatinine is greater than maximum serum creatinine for age/gender as described, then creatinine clearance (or radioisotope Glomerular Filtration Rate (GFR)) must be >60 ml/min/1.73 m2 - Urine dipstick < 2+ for proteinuria. Patients who have ≥2+ proteinuria on dipstick urinalysis should undergo a spot Protein/Creatinine ratio test that should be grade 2 per CTCAE v5.0 - No clinical evidence of nephrotic syndrome - Alanine Aminotransferase/Aspartate Aminotransferase (ALT/AST) ≤ 2.5 x Upper limit of normal (ULN) in the absence of liver metastases or ≤ 5.0 x ULN in the presence of liver metastases - Total bilirubin ≤ 1.5 x ULN (except Gilbert Syndrome: < 3.0 mg/dL) or ≤ 5.0 x ULN in the presence of liver metastases - Alkaline phosphatase (PAL) ≤2.5 x ULN (≤5 x ULN in patient with liver involvement of their cancer). If Alkaline phosphatase > 2.5 ULN, Gamma-Glutamyl Transferase GGT tests must be performed; GGT < 1.5 x ULN - Lipase ≤1.5 x ULN - INR (International Normalized Ratio) /PTT (Partial Thromboplatin Time) ≤1.5 x ULN","principalInclusionCriteriaTranslations":[{"id":11153314,"uuid":"de4d1dbc-11be-4fc6-9cc8-0171abc3d2e4","attributeTranslation":"Pour FOSTER-CabOS (première randomisation) - 11. Les valeurs de laboratoire doivent répondre aux critères suivants (selon la version 5 du CTCAE) et être obtenues dans les 7 jours précédant la randomisation\n- Numération absolue des neutrophiles ≥ 1 x 109/L\n- Plaquettes ≥ 100 x 109/L\n- Hémoglobine ≥ 8,0 g/dL (une hémoglobine inférieure à 8,0 g/dl est acceptable si elle est corrigée par un facteur de croissance ou une transfusion avant le C1D1)\n- Créatinine sérique ≤ 1,5 x LSN ou en fonction de l'âge/du sexe. Si la créatinine sérique est supérieure à la créatinine sérique maximale pour l'âge/le sexe décrit, alors la clairance de la créatinine (ou le débit de filtration glomérulaire (DFG) radio-isotopique) doit être > 60 ml/min/1,73 m2\n- Bandelette urinaire < 2+ pour la protéinurie. Les patients présentant une protéinurie ≥ 2+ à l'analyse d'urine par bandelette doivent subir un test ponctuel du rapport protéines/créatinine qui doit être de grade 2 selon le CTCAE v5.0\n- Aucun signe clinique de syndrome néphrotique\n- Alanine aminotransférase/aspartate aminotransférase (ALT/AST) ≤ 2,5 x limite supérieure de la normale (LSN) en l'absence de métastases hépatiques ou ≤ 5,0 x LSN en présence de métastases hépatiques\n- Bilirubine totale ≤ 1,5 x LSN (sauf syndrome de Gilbert : < 3,0 mg/dL) ou ≤ 5,0 x LSN en présence de métastases hépatiques\n- Phosphatase alcaline (PAL) ≤ 2,5 x LSN (≤ 5 x LSN chez les patients présentant une atteinte hépatique par leur cancer). Si la phosphatase alcaline est > 2,5 ULN, des tests de gamma-glutamyl transférase GGT doivent être effectués ; GGT < 1,5 x ULN\n- Lipase ≤ 1,5 x ULN\n- INR (rapport international normalisé) / PTT (temps de thromboplateine partiel) ≤ 1,5 x ULN","language":34,"languageDescription":"French (France)"},{"id":11153315,"uuid":"de4d1dbc-11be-4fc6-9cc8-0171abc3d2e4","attributeTranslation":"Para FOSTER-CabOS (primera aleatorización) - 11. Los valores de laboratorio de selección deben cumplir los siguientes criterios (según el CTCAE v5) y deben obtenerse en los 7 días previos a la aleatorización\n- Recuento absoluto de neutrófilos ≥ 1 x 109/L\n- Plaquetas ≥ 100 x 109/L\n- Hemoglobina ≥ 8,0 g/dL (se acepta una hemoglobina inferior a 8,0 g/dl si se corrige con factor de crecimiento o transfusión antes del C1D1)\n- Creatinina sérica ≤ 1,5 x LSN o según la edad/sexo. Si la creatinina sérica es superior a la creatinina sérica máxima para la edad/sexo descrita, entonces el aclaramiento de creatinina (o la tasa de filtración glomerular (TFG) radioisotópica) debe ser >60 ml/min/1,73 m2\n- Tira reactiva de orina < 2+ para proteinuria. Los pacientes que tengan ≥2+ proteinuria en el análisis de orina con tira reactiva deben someterse a una prueba de relación proteína/creatinina puntual que debe ser de grado 2 según el CTCAE v5.0\n- Sin evidencia clínica de síndrome nefrótico.\n- Alanina aminotransferasa/aspartato aminotransferasa (ALT/AST) ≤ 2,5 x límite superior de lo normal (LSN) en ausencia de metástasis hepáticas o ≤ 5,0 x LSN en presencia de metástasis hepáticas.\n- Bilirrubina total ≤ 1,5 x LSN (excepto síndrome de Gilbert: < 3,0 mg/dl) o ≤ 5,0 x LSN en presencia de metástasis hepáticas.\n- Fosfatasa alcalina (PAL) ≤ 2,5 x LSN (≤ 5 x LSN en pacientes con afectación hepática del cáncer). Si la fosfatasa alcalina es > 2,5 ULN, se deben realizar pruebas de gamma-glutamil transferasa GGT; GGT < 1,5 x ULN\n- Lipasa ≤1,5 x ULN\n- INR (índice internacional normalizado) /PTT (tiempo de tromboplastina parcial) ≤1,5 x ULN","language":7,"languageDescription":"Spanish"},{"id":11153316,"uuid":"de4d1dbc-11be-4fc6-9cc8-0171abc3d2e4","attributeTranslation":"Per FOSTER-CabOS (prima randomizzazione) - 11. I valori di laboratorio dello screening devono soddisfare i seguenti criteri (secondo CTCAE v5) e devono essere ottenuti entro 7 giorni, prima della randomizzazione: - Conta assoluta dei neutrofili ≥ 1 x 109/L; - Piastrine ≥ 100 x 109/L; - Emoglobina ≥ 8,0 g/dL (un'emoglobina inferiore a 8,0 g/dL è accettabile se corretta con fattore di crescita o trasfusione prima di C1D1); - Creatinina sierica ≤ 1,5 x ULN o in base a età/sesso. Se la creatinina sierica è superiore alla creatinina sierica massima per età/sesso come descritto, la clearance della creatinina (o velocità di filtrazione glomerulare (GFR) radioisotopica) deve essere >60 ml/min/1,73 m2; - Striscia urinaria < 2+ per proteinuria. I pazienti che presentano proteinuria ≥2+ all'analisi delle urine con dipstick devono sottoporsi a un test spot del rapporto proteine/creatinina che deve essere di grado 2 secondo CTCAE v5.0; - Nessuna evidenza clinica di sindrome nefrosica; - Alanina aminotransferasi/Aspartato aminotransferasi (ALT/AST) ≤ 2,5 x limite superiore della norma (ULN) in assenza di metastasi epatiche o ≤ 5,0 x ULN in presenza di metastasi epatiche; - Bilirubina totale ≤ 1,5 x ULN (eccetto sindrome di Gilbert: < 3,0 mg/dL) o ≤ 5,0 x ULN in presenza di metastasi epatiche; - Fosfatasi alcalina (PAL) ≤2,5 x ULN (≤5 x ULN nei pazienti con coinvolgimento epatico del tumore). Se la fosfatasi alcalina > 2,5 ULN, devono essere eseguiti i test della gamma-glutamil transferasi GGT; GGT < 1,5 x ULN; - Lipasi ≤1,5 x ULN; - INR (rapporto internazionale normalizzato) /PTT (tempo di tromboplatino parziale) ≤1,5 x ULN","language":14,"languageDescription":"Italian"},{"id":11153318,"uuid":"de4d1dbc-11be-4fc6-9cc8-0171abc3d2e4","attributeTranslation":"Voor FOSTER-CabOS,(eerste randomisatie) - 11.Screeninglaboratoriumwaarden moeten aan de volgende criteria voldoen (volgens CTCAE v5) en moeten binnen 7 dagen voor de randomisatie worden verkregen\n- Absoluut aantal neutrofielen ≥ 1 x 109/L\n- Bloedplaatjes ≥ 100 x 109/L \n- Hemoglobine ≥ 8,0 g/dl (een hemoglobinegehalte van minder dan 8,0 g/dl is aanvaardbaar als dit wordt gecorrigeerd door groeifactor of transfusie vóór C1D1)\n- Serumcreatinine ≤ 1,5 x ULN of gebaseerd op leeftijd/geslacht. Als de serumcreatinine hoger is dan de maximale serumcreatinine voor leeftijd/geslacht zoals beschreven, dan moet de creatinineklaring (of de glomerulaire filtratiesnelheid (GFR) met radioisotopen) >60 ml/min/1,73 m2 zijn.\n- Urinedipstick < 2+ voor proteïnurie. Patiënten met ≥2+ proteïnurie op dipstick urineonderzoek moeten een spot Protein/Creatinine ratio test ondergaan die graad 2 moet zijn volgens CTCAE v5.0.\n- Geen klinisch bewijs van nefrotisch syndroom\n- Alanine Aminotransferase/Aspartaat Aminotransferase (ALT/AST) ≤ 2,5 x de bovengrens van normaal (ULN) in afwezigheid van levermetastasen of ≤ 5,0 x ULN in aanwezigheid van levermetastasen\n- Totale bilirubine ≤ 1,5 x ULN (behalve Gilbert Syndroom: < 3,0 mg/dL) of ≤ 5,0 x ULN in aanwezigheid van levermetastasen\n- Alkalische fosfatase (PAL) ≤ 2,5 x ULN (≤ 5 x ULN bij patiënten met leverbetrokkenheid van hun kanker). Als alkalische fosfatase > 2,5 ULN, moeten gammaglutamyltransferase GGT-tests worden uitgevoerd; GGT < 1,5 x ULN\n- Lipase ≤ 1,5 x ULN\n- INR (International Normalized Ratio) /PTT (Partial Thromboplatin Time) ≤1,5 x ULN","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11153317,"uuid":"de4d1dbc-11be-4fc6-9cc8-0171abc3d2e4","attributeTranslation":"W ramach FOSTER-CabOS (pierwsza randomizacja) - 11. Wyniki badań laboratoryjnych muszą spełniać następujące kryteria (zgodnie z CTCAE v5) i powinny być uzyskane w ciągu 7 dni przed randomizacją\n- Bezwzględna liczba neutrofili ≥ 1 x 109/l\n- Płytki krwi ≥ 100 x 109/l\n- Hemoglobina ≥ 8,0 g/dl (hemoglobina poniżej 8,0 g/dl jest dopuszczalna, jeśli zostanie skorygowana czynnikiem wzrostu lub transfuzją przed C1D1)\n- Stężenie kreatyniny w surowicy ≤ 1,5 x ULN lub w oparciu o wiek/płeć. Jeśli stężenie kreatyniny w surowicy jest większe niż maksymalne stężenie kreatyniny w surowicy dla danego wieku/płci, jak opisano, wówczas klirens kreatyniny (lub radioizotopowa szybkość przesączania kłębuszkowego (GFR)) musi wynosić >60 ml/min/1,73 m2\n- Wynik badania testu paskowego moczu < 2+ dla białkomoczu. Pacjenci, u których wynik badania testem paskowym wynosi ≥2+, powinni zostać poddani badaniu stosunku białka do kreatyniny, które powinno wynosić 2 zgodnie z CTCAE v5.0\n- Brak klinicznych objawów zespołu nerczycowego.\n- Aminotransferaza alaninowa/aminotransferaza asparaginianowa (ALT/AST) ≤ 2,5 x górna granica normy (GGN) przy braku przerzutów do wątroby lub ≤ 5,0 x GGN przy obecności przerzutów do wątroby.\n- Bilirubina całkowita ≤ 1,5 x ULN (z wyjątkiem zespołu Gilberta: < 3,0 mg/dl) lub ≤ 5,0 x ULN w przypadku przerzutów do wątroby\n- Fosfataza alkaliczna (PAL) ≤2,5 x ULN (≤5 x ULN u pacjentów z zajęciem wątroby przez nowotwór). Jeśli fosfataza alkaliczna > 2,5 ULN, należy wykonać badania gamma-glutamylotransferazy GGT; GGT < 1,5 x ULN\n- Lipaza ≤1,5 x ULN\n- INR (międzynarodowy współczynnik znormalizowany) /PTT (częściowy czas tromboplastyny) ≤1,5 x ULN","language":19,"languageDescription":"Polish"}]},{"id":903265,"number":17,"principalInclusionCriteria":"For FOSTER-CabOS (first randomization) - 12. Patients who are therapeutically treated with an agent such as warfarin or heparin/ Low-molecular-weight heparin (LMWH) will be allowed to participate provided that no prior evidence of underlying abnormality in coagulation parameters exists.","principalInclusionCriteriaTranslations":[{"id":11153322,"uuid":"32cc2d0f-28e7-493f-9f96-d3b8f7a16d59","attributeTranslation":"Pour FOSTER-CabOS (première randomisation) - 12. Les patients traités par un agent tel que la warfarine ou l'héparine/héparine de bas poids moléculaire (HBPM) seront autorisés à participer à condition qu'il n'existe aucune preuve préalable d'anomalie sous-jacente des paramètres de coagulation.","language":34,"languageDescription":"French (France)"},{"id":11153320,"uuid":"32cc2d0f-28e7-493f-9f96-d3b8f7a16d59","attributeTranslation":"Para FOSTER-CabOS (primera aleatorización) - 12. Los pacientes que estén recibiendo tratamiento terapéutico con un agente como warfarina o heparina/heparina de bajo peso molecular (HBPM) podrán participar siempre que no existan pruebas previas de anomalías subyacentes en los parámetros de coagulación.","language":7,"languageDescription":"Spanish"},{"id":11153321,"uuid":"32cc2d0f-28e7-493f-9f96-d3b8f7a16d59","attributeTranslation":"Voor FOSTER-CabOS,(eerste randomisatie) - 12. Patiënten die therapeutisch worden behandeld met een middel als warfarine of heparine/heparine met laag moleculair gewicht (LMWH) mogen deelnemen op voorwaarde dat er geen eerdere aanwijzingen zijn voor onderliggende afwijkingen in stollingsparameters.","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11153323,"uuid":"32cc2d0f-28e7-493f-9f96-d3b8f7a16d59","attributeTranslation":"Per FOSTER-CabOS (prima randomizzazione) - 12. I pazienti sottoposti a trattamento terapeutico con un agente come warfarin o eparina/eparina a basso peso molecolare (LMWH) potranno partecipare a condizione che non vi siano precedenti evidenze di anomalie sottostanti nei parametri della coagulazione.","language":14,"languageDescription":"Italian"},{"id":11153319,"uuid":"32cc2d0f-28e7-493f-9f96-d3b8f7a16d59","attributeTranslation":"W ramach FOSTER-CabOS (pierwsza randomizacja) - 12. Pacjenci leczeni terapeutycznie środkami takimi jak warfaryna lub heparyna/heparyna drobnocząsteczkowa (LMWH) będą mogli uczestniczyć w badaniu, pod warunkiem że nie ma wcześniejszych dowodów na występowanie nieprawidłowości w parametrach krzepnięcia.","language":19,"languageDescription":"Polish"}]},{"id":903266,"number":18,"principalInclusionCriteria":"For FOSTER-CabOS (first randomization) - 13. Women of childbearing potential or young women of chilbearing potential and who started their puberty (menarche) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of Human Chorionic Gonadotropin (HCG)) done within 7 days prior to randomisation.","principalInclusionCriteriaTranslations":[{"id":11153328,"uuid":"25d30871-2458-4fe1-90bb-7a2c1db29d1f","attributeTranslation":"Per FOSTER-CabOS (prima randomizzazione) - 13. Le donne in età fertile o le ragazze in età fertile che hanno raggiunto la pubertà (menarca) devono avere un test di gravidanza negativo su siero o urine (sensibilità minima 25 UI/L o unità equivalenti di gonadotropina corionica umana (HCG)) effettuato entro 7 giorni prima della randomizzazione.","language":14,"languageDescription":"Italian"},{"id":11153327,"uuid":"25d30871-2458-4fe1-90bb-7a2c1db29d1f","attributeTranslation":"Para FOSTER-CabOS (primera aleatorización) - 13. Las mujeres en edad fértil o mujeres jóvenes en edad fértil que hayan iniciado la pubertad (menarquia) deben someterse a una prueba de embarazo en suero o en orina con resultado negativo (sensibilidad mínima de 25 UI/L o unidades equivalentes de gonadotropina coriónica humana [HCG]) realizada en los 7 días previos a la aleatorización.","language":7,"languageDescription":"Spanish"},{"id":11153324,"uuid":"25d30871-2458-4fe1-90bb-7a2c1db29d1f","attributeTranslation":"Pour FOSTER-CabOS (première randomisation) - 13. Les femmes en âge de procréer ou les jeunes femmes en age de procréer et qui ont débuté leur puberté (prémières règles) doivent présenter un test de grossesse sérique ou urinaire négatif (sensibilité minimale de 25 UI/L ou unités équivalentes de gonadotrophine chorionique humaine (HCG)) effectué dans les 7 jours précédant la randomisation.","language":34,"languageDescription":"French (France)"},{"id":11153325,"uuid":"25d30871-2458-4fe1-90bb-7a2c1db29d1f","attributeTranslation":"Voor FOSTER-CabOS,(eerste randomisatie) - 13. Vrouwen in de vruchtbare leeftijd of jonge vrouwen in de vruchtbare leeftijd die de puberteit hebben bereikt (menarche) moeten een negatieve serum- of urinezwangerschapstest (minimale gevoeligheid 25 IU/L of equivalente eenheden humaan choriongonadotrofine (HCG)) hebben gedaan binnen 7 dagen voorafgaand aan de randomisatie.","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11153326,"uuid":"25d30871-2458-4fe1-90bb-7a2c1db29d1f","attributeTranslation":"W ramach FOSTER-CabOS (pierwsza randomizacja) - 13. Kobiety w wieku rozrodczym lub młode kobiety w wieku rozrodczym, które weszły w okres dojrzewania (pierwsza miesiączka) muszą uzyskać ujemny wynik testu ciążowego w surowicy lub moczu (minimalna czułość 25 IU/l lub równoważne jednostki ludzkiej gonadotropiny kosmówkowej (HCG)) wykonanego w ciągu 7 dni przed randomizacją.","language":19,"languageDescription":"Polish"}]},{"id":903267,"number":19,"principalInclusionCriteria":"For FOSTER-CabOS (first randomization) - 14.Effective methods of contraception should be used by male and female patients and their partners during therapy, and for at least 4 months after completing therapy. Because oral contraceptives might not be considered as “effective methods of contraception”, they should be used together with another method, such as a barrier method, according to age and gynaecologist advice.","principalInclusionCriteriaTranslations":[{"id":11153329,"uuid":"c450827e-8efc-48c4-b9cd-8ee551c81527","attributeTranslation":"W ramach FOSTER-CabOS (pierwsza randomizacja) - 14. Pacjenci płci męskiej i żeńskiej oraz ich partnerzy powinni stosować skuteczne metody antykoncepcji podczas terapii oraz przez co najmniej 4 miesiące po jej zakończeniu. Ponieważ doustne środki antykoncepcyjne mogą nie być uznawane za „skuteczne metody antykoncepcji”, należy je stosować łącznie z inną metodą, taką jak metoda barierowa, zgodnie z wiekiem i zaleceniami ginekologa (patrz przykłady poniżej).","language":19,"languageDescription":"Polish"},{"id":11153333,"uuid":"c450827e-8efc-48c4-b9cd-8ee551c81527","attributeTranslation":"Voor FOSTER-CabOS,(eerste randomisatie) - 14. Effectieve anticonceptiemethoden moeten door mannelijke en vrouwelijke patiënten en hun partners worden gebruikt tijdens de therapie en gedurende ten minste 4 maanden na beëindiging van de therapie. Omdat orale anticonceptiemiddelen mogelijk niet als “effectieve anticonceptiemethoden” worden beschouwd, moeten ze samen met een andere methode worden gebruikt, zoals een barrièremethode, afhankelijk van de leeftijd en het advies van de gynaecoloog (zie onderstaande voorbeelden).","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11153331,"uuid":"c450827e-8efc-48c4-b9cd-8ee551c81527","attributeTranslation":"Para FOSTER-CabOS (primera aleatorización) - 14. Los pacientes masculinos y femeninos y sus parejas deben utilizar métodos anticonceptivos eficaces durante el tratamiento y durante al menos 4 meses después de finalizarlo. Dado que los anticonceptivos orales podrían no considerarse «métodos anticonceptivos eficaces», deben utilizarse junto con otro método, como un método de barrera, según la edad y el consejo del ginecólogo (véanse los ejemplos a continuación).","language":7,"languageDescription":"Spanish"},{"id":11153330,"uuid":"c450827e-8efc-48c4-b9cd-8ee551c81527","attributeTranslation":"Pour FOSTER-CabOS (première randomisation) - 14. Des méthodes contraceptives efficaces doivent être utilisées par les patients masculins et féminins et leurs partenaires pendant le traitement et pendant au moins 4 mois après la fin du traitement. Les contraceptifs oraux pouvant ne pas être considérés comme des « méthodes contraceptives efficaces », ils doivent être utilisés en association avec une autre méthode, telle qu'une méthode barrière, en fonction de l'âge et des conseils du gynécologue","language":34,"languageDescription":"French (France)"},{"id":11153332,"uuid":"c450827e-8efc-48c4-b9cd-8ee551c81527","attributeTranslation":"Per FOSTER-CabOS (prima randomizzazione) - 14. I pazienti di entrambi i sessi e i loro partner devono utilizzare metodi contraccettivi efficaci durante la terapia e per almeno 4 mesi dopo il suo completamento. Poiché i contraccettivi orali potrebbero non essere considerati \"metodi contraccettivi efficaci\", devono essere utilizzati insieme a un altro metodo, come un metodo di barriera, in base all'età e al parere del ginecologo (vedere esempi di seguito).","language":14,"languageDescription":"Italian"}]},{"id":903268,"number":2,"principalInclusionCriteria":"For FOSTER evolving study platform - 2. Patient considered medically fit to receive systemic treatment","principalInclusionCriteriaTranslations":[{"id":11153337,"uuid":"f27beb7e-f8f5-4da1-b799-00116ca6aae7","attributeTranslation":"Para la plataforma del estudio FOSTER-evolving -2. Paciente considerado médicamente apto para recibir tratamiento sistémico","language":7,"languageDescription":"Spanish"},{"id":11153338,"uuid":"f27beb7e-f8f5-4da1-b799-00116ca6aae7","attributeTranslation":"De l’étude évolutive plateforme FOSTER - 2. Patient considéré comme médicalement apte à recevoir un traitement systémique","language":34,"languageDescription":"French (France)"},{"id":11153335,"uuid":"f27beb7e-f8f5-4da1-b799-00116ca6aae7","attributeTranslation":"W ramach badania FOSTER - 2. Pacjent uznany za zdolnego z medycznego punktu widzenia do leczenia systemowego","language":19,"languageDescription":"Polish"},{"id":11153336,"uuid":"f27beb7e-f8f5-4da1-b799-00116ca6aae7","attributeTranslation":"Voor het FOSTER onderzoeksplatfom - 2. Patiënt wordt medisch geschikt geacht voor systemische behandeling,","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11153334,"uuid":"f27beb7e-f8f5-4da1-b799-00116ca6aae7","attributeTranslation":"Per lo studio evolutivo della piattaforma FOSTER - 2. Paziente ritenuto clinicamente idoneo a ricevere un trattamento sistemico.","language":14,"languageDescription":"Italian"}]},{"id":903269,"number":20,"principalInclusionCriteria":"For FOSTER-CabOS (first randomization) - 15. Provision of dated and signed written informed consent for the randomised trial prior to any study specific procedures, sampling and analyses.","principalInclusionCriteriaTranslations":[{"id":11153343,"uuid":"f737045e-ad90-4f82-9113-b586dbf18c1b","attributeTranslation":"Para FOSTER-CabOS (primera aleatorización) - 15. Presentación del consentimiento informado por escrito, fechado y firmado, para el ensayo aleatorio antes de cualquier procedimiento específico del estudio, muestreo y análisis.","language":7,"languageDescription":"Spanish"},{"id":11153339,"uuid":"f737045e-ad90-4f82-9113-b586dbf18c1b","attributeTranslation":"Pour FOSTER-CabOS (première randomisation) - 15. Fourniture d'un consentement éclairé écrit, daté et signé, pour l'essai randomisé avant toute procédure, tout prélèvement et toute analyse spécifiques à l'étude.","language":34,"languageDescription":"French (France)"},{"id":11153341,"uuid":"f737045e-ad90-4f82-9113-b586dbf18c1b","attributeTranslation":"W ramach FOSTER-CabOS (pierwsza randomizacja) - 15. Dostarczenie datowanej i podpisanej pisemnej świadomej zgody na udział w badaniu z randomizacją przed podjęciem jakichkolwiek procedur związanych z badaniem, pobieraniem próbek i analizami.","language":19,"languageDescription":"Polish"},{"id":11153340,"uuid":"f737045e-ad90-4f82-9113-b586dbf18c1b","attributeTranslation":"Per FOSTER-CabOS (prima randomizzazione) - 15. Fornitura del consenso informato scritto, datato e firmato per la sperimentazione randomizzata prima di qualsiasi procedura, campionamento e analisi specifica dello studio.","language":14,"languageDescription":"Italian"},{"id":11153342,"uuid":"f737045e-ad90-4f82-9113-b586dbf18c1b","attributeTranslation":"Voor FOSTER-CabOS,(eerste randomisatie) - 15.Voorlegging van gedateerde en ondertekende schriftelijke geïnformeerde toestemming voor de gerandomiseerde studie voorafgaand aan alle studiespecifieke procedures, bemonstering en analyses.","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":903270,"number":21,"principalInclusionCriteria":"For FOSTER-CabOS (first randomization) - 16. Affiliation to a social insurance or equivalent regimen (if required in the country).","principalInclusionCriteriaTranslations":[{"id":11153347,"uuid":"fc42e704-8e25-46b5-b548-180b98612501","attributeTranslation":"W ramach FOSTER-CabOS (pierwsza randomizacja) - 16. Przynależność do systemu ubezpieczeń społecznych lub równoważnego systemu (jeśli jest to wymagane w danym kraju).","language":19,"languageDescription":"Polish"},{"id":11153344,"uuid":"fc42e704-8e25-46b5-b548-180b98612501","attributeTranslation":"Per FOSTER-CabOS (prima randomizzazione) - 16. Iscrizione a un regime previdenziale o equivalente (se richiesto nel Paese).","language":14,"languageDescription":"Italian"},{"id":11153345,"uuid":"fc42e704-8e25-46b5-b548-180b98612501","attributeTranslation":"Para FOSTER-CabOS (primera aleatorización) - 16. Afiliación a un régimen de seguridad social o equivalente (si es obligatorio en el país).","language":7,"languageDescription":"Spanish"},{"id":11153348,"uuid":"fc42e704-8e25-46b5-b548-180b98612501","attributeTranslation":"Voor FOSTER-CabOS,(eerste randomisatie) - 16.Aansluiting bij een sociale verzekering of gelijkwaardig stelsel (indien vereist in het land).","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11153346,"uuid":"fc42e704-8e25-46b5-b548-180b98612501","attributeTranslation":"Pour FOSTER-CabOS (première randomisation) - 16. Affiliation à un régime d'assurance sociale ou équivalent (si requis dans le pays).","language":34,"languageDescription":"French (France)"}]},{"id":903271,"number":3,"principalInclusionCriteria":"For FOSTER evolving study platform - 3. Planned systemic therapy according to national guidelines and age","principalInclusionCriteriaTranslations":[{"id":11153352,"uuid":"9b127bb1-55d0-434e-b064-1c0b3017b5df","attributeTranslation":"Para la plataforma del estudio FOSTER-evolving - 3. Terapia sistémica planificada de acuerdo con las directrices nacionales y la edad","language":7,"languageDescription":"Spanish"},{"id":11153350,"uuid":"9b127bb1-55d0-434e-b064-1c0b3017b5df","attributeTranslation":"W ramach badania FOSTER - 3. Planowane leczenie systemowe zgodnie z wytycznymi krajowymi i wiekiem","language":19,"languageDescription":"Polish"},{"id":11153349,"uuid":"9b127bb1-55d0-434e-b064-1c0b3017b5df","attributeTranslation":"De l’étude évolutive plateforme FOSTER - 3. Traitement systémique prévu conformément aux directives nationales et à l'âge du patient","language":34,"languageDescription":"French (France)"},{"id":11153351,"uuid":"9b127bb1-55d0-434e-b064-1c0b3017b5df","attributeTranslation":"Per lo studio evolutivo della piattaforma FOSTER - 3. Terapia sistemica pianificata secondo le linee guida nazionali e l'età.","language":14,"languageDescription":"Italian"},{"id":11153353,"uuid":"9b127bb1-55d0-434e-b064-1c0b3017b5df","attributeTranslation":"Voor het FOSTER onderzoeksplatfom - 3. Geplande systemische therapie volgens nationale richtlijnen en leeftijd","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":903272,"number":4,"principalInclusionCriteria":"For FOSTER evolving study platform - 4. Written informed consent from patients and/or their parents/ guardians before enrolment and any study-related procedure.","principalInclusionCriteriaTranslations":[{"id":11153354,"uuid":"d27cbd0b-05b6-4780-aec3-7f1c5b1f5f67","attributeTranslation":"De l’étude évolutive plateforme FOSTER - 4. Consentement éclairé écrit des patients et/ou de leurs parents/tuteurs avant l'inscription et toute procédure liée à l'étude.","language":34,"languageDescription":"French (France)"},{"id":11153356,"uuid":"d27cbd0b-05b6-4780-aec3-7f1c5b1f5f67","attributeTranslation":"Voor het FOSTER onderzoeksplatfom - 4. Schriftelijke geïnformeerde toestemming van patiënten en/of hun ouders/voogden vóór deelname en elke studiegerelateerde procedure.","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11153358,"uuid":"d27cbd0b-05b6-4780-aec3-7f1c5b1f5f67","attributeTranslation":"W ramach badania FOSTER - 4. Pisemna świadoma zgoda pacjentów i/lub ich rodziców/opiekunów przed włączeniem do badania i jakąkolwiek procedurą związaną z badaniem","language":19,"languageDescription":"Polish"},{"id":11153355,"uuid":"d27cbd0b-05b6-4780-aec3-7f1c5b1f5f67","attributeTranslation":"Per lo studio evolutivo della piattaforma FOSTER - 4. Consenso informato scritto ottenuto dai pazienti e/o dei loro genitori/tutori prima dell'arruolamento e di qualsiasi procedura correlata allo studio.","language":14,"languageDescription":"Italian"},{"id":11153357,"uuid":"d27cbd0b-05b6-4780-aec3-7f1c5b1f5f67","attributeTranslation":"Para la plataforma del estudio FOSTER-evolving - 4. Consentimiento informado por escrito de los pacientes y/o sus padres/tutores antes de la inscripción y de cualquier procedimiento relacionado con el estudio.","language":7,"languageDescription":"Spanish"}]},{"id":903273,"number":5,"principalInclusionCriteria":"For FOSTER evolving study platform - 5. Affiliation to a social insurance or equivalent regimen (if required in the country)","principalInclusionCriteriaTranslations":[{"id":11153361,"uuid":"d6caff08-eb7c-41ff-99ac-8e61e7576162","attributeTranslation":"Para la plataforma del estudio FOSTER-evolving - 5. Afiliación a un seguro social o régimen equivalente (si se exige en el país).","language":7,"languageDescription":"Spanish"},{"id":11153360,"uuid":"d6caff08-eb7c-41ff-99ac-8e61e7576162","attributeTranslation":"Per lo studio evolutivo della piattaforma FOSTER - 5. Iscrizione a un regime previdenziale o equivalente (se richiesto nel Paese).","language":14,"languageDescription":"Italian"},{"id":11153362,"uuid":"d6caff08-eb7c-41ff-99ac-8e61e7576162","attributeTranslation":"De l’étude évolutive plateforme FOSTER - 5. Affiliation à la sécurité sociale ou régime équivalent (si requis dans le pays)","language":34,"languageDescription":"French (France)"},{"id":11153363,"uuid":"d6caff08-eb7c-41ff-99ac-8e61e7576162","attributeTranslation":"Voor het FOSTER onderzoeksplatfom - 5. Aansluiting bij een sociale verzekering of gelijkwaardig regeling (indien vereist in het land).","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11153359,"uuid":"d6caff08-eb7c-41ff-99ac-8e61e7576162","attributeTranslation":"W ramach badania FOSTER - 5. Przynależność do ubezpieczenia społecznego lub równoważnego systemu (jeśli jest to wymagane w danym kraju)","language":19,"languageDescription":"Polish"}]},{"id":903274,"number":6,"principalInclusionCriteria":"For FOSTER-CabOS (first randomization)- 1. Patient with a histologically proven and confirmed high-grade osteosarcoma, according to the criteria described in the last World Health Organization (WHO) classification of Soft Tissue and Bone Tumours, after the exclusion of all potential differential diagnoses, either by local pathologists with expertise in bone sarcomas, or through centralized revision in a referral centre, according to national rules.","principalInclusionCriteriaTranslations":[{"id":11153368,"uuid":"fe1c9f04-877f-4c96-b921-b8b4d313a08f","attributeTranslation":"Pour FOSTER-CabOS (première randomisation) - 1. Patient présentant un ostéosarcome de haut grade confirmé par examen histologique, selon les critères décrits dans la dernière classification de l'Organisation mondiale de la santé (OMS) des tumeurs des tissus mous et des os, après exclusion de tous les diagnostics différentiels potentiels, soit par des pathologistes locaux spécialisés dans les sarcomes osseux, soit par une révision centralisée dans un centre de référence, conformément aux règles nationales.","language":34,"languageDescription":"French (France)"},{"id":11153364,"uuid":"fe1c9f04-877f-4c96-b921-b8b4d313a08f","attributeTranslation":"Para FOSTER-CabOS (primera aleatorización) - 1. Paciente con osteosarcoma de alto grado confirmado y demostrado histológicamente, según los criterios descritos en la última clasificación de la Organización Mundial de la Salud (OMS) de tumores de tejidos blandos y huesos, tras la exclusión de todos los posibles diagnósticos diferenciales, ya sea por patólogos locales con experiencia en sarcomas óseos o mediante revisión centralizada en un centro de referencia, de acuerdo con la normativa nacional.","language":7,"languageDescription":"Spanish"},{"id":11153366,"uuid":"fe1c9f04-877f-4c96-b921-b8b4d313a08f","attributeTranslation":"W ramach FOSTER-CabOS (pierwsza randomizacja) - 1. Pacjent z histologicznie potwierdzonym kostniakomięsakiem wysokiego ryzyka, zgodnie z kryteriami opisanymi w najnowszej klasyfikacji Światowej Organizacji Zdrowia (WHO) guzów tkanek miękkich i kości, po wykluczeniu wszystkich innych potencjalnych rozpoznań, albo przez lokalnych patologów specjalizujących się w mięsakach kości, albo poprzez scentralizowaną rewizję w ośrodku referencyjnym, zgodnie z przepisami krajowymi.","language":19,"languageDescription":"Polish"},{"id":11153365,"uuid":"fe1c9f04-877f-4c96-b921-b8b4d313a08f","attributeTranslation":"Voor FOSTER-CabOS,(eerste randomisatie) - 1. Patiënt met een histologisch bewezen en bevestigd hooggradig osteosarcoom, volgens de criteria beschreven in de laatste classificatie van de Wereldgezondheidsorganisatie (WHO) van weke delen en bottumoren, na uitsluiting van alle mogelijke differentiële diagnoses, ofwel door lokale pathologen met expertise in botsarcomen, ofwel door middel van gecentraliseerde revisie in een referentiecentrum, volgens nationale regels.","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11153367,"uuid":"fe1c9f04-877f-4c96-b921-b8b4d313a08f","attributeTranslation":"Per FOSTER-CabOS (prima randomizzazione) - 1. Paziente con osteosarcoma ad alto grado confermato e provato istologicamente, secondo i criteri descritti nell'ultima classificazione dell'Organizzazione Mondiale della Sanità (OMS) dei tumori ossei e dei tessuti molli, dopo l'esclusione di tutte le potenziali diagnosi differenziali, sia da parte di patologi locali esperti in sarcomi ossei, sia tramite revisione centralizzata in un centro di riferimento, secondo le norme nazionali.","language":14,"languageDescription":"Italian"}]},{"id":903275,"number":7,"principalInclusionCriteria":"For FOSTER-CabOS (first randomization) - 2. Age ≥ 4 years old (when able to swallow tablet) ; no upper age limit","principalInclusionCriteriaTranslations":[{"id":11153370,"uuid":"921e68f4-1f8d-4b5d-afe5-245236071369","attributeTranslation":"W ramach FOSTER-CabOS (pierwsza randomizacja) - 2. Wiek ≥ 4 lata (pod warunkiem gdy pacjent jest w stanie połknąć tabletkę); brak górnej granicy wieku","language":19,"languageDescription":"Polish"},{"id":11153372,"uuid":"921e68f4-1f8d-4b5d-afe5-245236071369","attributeTranslation":"Pour FOSTER-CabOS (première randomisation) - 2. Âge ≥ 4 ans (lorsque le patient est capable d'avaler des comprimés) ; pas de limite d'âge supérieure.","language":34,"languageDescription":"French (France)"},{"id":11153371,"uuid":"921e68f4-1f8d-4b5d-afe5-245236071369","attributeTranslation":"Voor FOSTER-CabOS,(eerste randomisatie) - 2. Leeftijd ≥ 4 jaar (wanneer tablet doorgeslikt kan worden); geen boven leeftijdsgrens","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11153369,"uuid":"921e68f4-1f8d-4b5d-afe5-245236071369","attributeTranslation":"Para FOSTER-CabOS (primera aleatorización) - 2. Edad ≥ 4 años (cuando se pueda tragar comprimidos); sin límite de edad máxima.","language":7,"languageDescription":"Spanish"},{"id":11153373,"uuid":"921e68f4-1f8d-4b5d-afe5-245236071369","attributeTranslation":"Per FOSTER-CabOS (prima randomizzazione) - 2. Età ≥ 4 anni (quando è in grado di deglutire la compressa); nessun limite di età superiore.","language":14,"languageDescription":"Italian"}]},{"id":903276,"number":8,"principalInclusionCriteria":"For FOSTER-CabOS (first randomization) - 3. First line systemic and local treatment of primary tumour (and metastasis when present) for localised or metastatic osteosarcoma must have been completed according to national guidelines (Mifamurtide is allowed according to centre’s practices)","principalInclusionCriteriaTranslations":[{"id":11153375,"uuid":"3b88ba5a-9ce1-4e45-9a65-c296dc2cb447","attributeTranslation":"Pour FOSTER-CabOS (première randomisation) - 3. Le traitement systémique et local de première intention de la tumeur primaire (et des métastases, le cas échéant) pour un ostéosarcome localisé ou métastatique doit avoir été achevé conformément aux directives nationales (le mifamurtide est autorisé selon les pratiques du centre).","language":34,"languageDescription":"French (France)"},{"id":11153376,"uuid":"3b88ba5a-9ce1-4e45-9a65-c296dc2cb447","attributeTranslation":"W ramach FOSTER-CabOS (pierwsza randomizacja) - 3.Pierwsza linia leczenia ogólnoustrojowego i miejscowego guza pierwotnego (oraz przerzutów, jeśli występują) w przypadku zlokalizowanego lub przerzutowego osteosarcoma musi zostać zakończona zgodnie z krajowymi wytycznymi (stosowanie mifamurtidu jest dozwolone zgodnie z praktyką ośrodka).","language":19,"languageDescription":"Polish"},{"id":11153374,"uuid":"3b88ba5a-9ce1-4e45-9a65-c296dc2cb447","attributeTranslation":"Para FOSTER-CabOS (primera aleatorización) - 3. El tratamiento sistémico y local de primera línea del tumor primario (y de las metástasis, si las hay) para el osteosarcoma localizado o metastásico debe haberse completado de acuerdo con las directrices nacionales (se permite el uso de mifamurtida según las prácticas del centro).","language":7,"languageDescription":"Spanish"},{"id":11153378,"uuid":"3b88ba5a-9ce1-4e45-9a65-c296dc2cb447","attributeTranslation":"Voor FOSTER-CabOS,(eerste randomisatie) - 3. Eerstelijns systemische en lokale behandeling van de primaire tumor (en metastasen indien aanwezig) voor gelokaliseerd of gemetastaseerd osteosarcoom moet zijn afgerond volgens de nationale richtlijnen (Mifamurtide is toegestaan volgens de praktijken van het centrum).","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11153377,"uuid":"3b88ba5a-9ce1-4e45-9a65-c296dc2cb447","attributeTranslation":"Per FOSTER-CabOS (prima randomizzazione) - 3. Il trattamento sistemico e locale di prima linea del tumore primario (e delle metastasi, se presenti) per l'osteosarcoma localizzato o metastatico deve essere completato secondo le linee guida nazionali (la mifamurtide è consentita esclusivamente in base alle pratiche del centro).","language":14,"languageDescription":"Italian"}]},{"id":903277,"number":9,"principalInclusionCriteria":"For FOSTER-CabOS (first randomization) - 4. Recovery to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5 Grade 0 or 1 level or recovery to baseline health status preceding the prior treatment from any previous drug/procedure related toxicity (except alopecia, anaemia, and hypothyroidism)","principalInclusionCriteriaTranslations":[{"id":11153383,"uuid":"92f47526-99b2-4627-9dbe-33d79bbc8666","attributeTranslation":"Para FOSTER-CabOS (primera aleatorización) - 4. Recuperación hasta el nivel 0 o 1 de los Criterios Comunes de Terminología para Eventos Adversos del Instituto Nacional del Cáncer (NCI-CTCAE) v5 o recuperación hasta el estado de salud basal anterior al tratamiento previo de cualquier toxicidad relacionada con fármacos o procedimientos anteriores (excepto alopecia, anemia e hipotiroidismo).","language":7,"languageDescription":"Spanish"},{"id":11153382,"uuid":"92f47526-99b2-4627-9dbe-33d79bbc8666","attributeTranslation":"Pour FOSTER-CabOS (première randomisation) - 4. Rétablissement conforme aux critères communs de terminologie des événements indésirables du National Cancer Institute (NCI-CTCAE) v5 de niveau 0 ou 1 ou rétablissement de l'état de santé de base précédant le traitement antérieur à partir de toute toxicité liée à un médicament/une procédure antérieure (à l'exception de l'alopécie, de l'anémie et de l'hypothyroïdie)","language":34,"languageDescription":"French (France)"},{"id":11153380,"uuid":"92f47526-99b2-4627-9dbe-33d79bbc8666","attributeTranslation":"Per FOSTER-CabOS (prima randomizzazione) - 4. Recupero al livello 0 o 1 secondo i criteri terminologici comuni del National Cancer Institute (NCI-CTCAE) v5 per gli eventi avversi o recupero allo stato di salute basale precedente al trattamento precedente da qualsiasi precedente tossicità correlata a farmaci/procedure (eccetto alopecia, anemia e ipotiroidismo)","language":14,"languageDescription":"Italian"},{"id":11153379,"uuid":"92f47526-99b2-4627-9dbe-33d79bbc8666","attributeTranslation":"W ramach FOSTER-CabOS (pierwsza randomizacja) - 4. Powrót do stopnia 0 lub 1 wg kryteriów National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5 lub powrót do stanu zdrowia wyjściowego sprzed wcześniejszego leczenia po wszelkich wcześniejszych toksycznościach związanych z lekami/procedurami (z wyjątkiem łysienia, anemii i niedoczynności tarczycy).","language":19,"languageDescription":"Polish"},{"id":11153381,"uuid":"92f47526-99b2-4627-9dbe-33d79bbc8666","attributeTranslation":"Voor FOSTER-CabOS,(eerste randomisatie) - 4. Herstel tot het niveau van de Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5 graad 0 of 1 van het National Cancer Institute of herstel tot de gezondheidstoestand op de basislijn voorafgaand aan de eerdere behandeling na eerdere geneesmiddel-/proceduregerelateerde toxiciteit (met uitzondering van alopecia, anemie en hypothyreoïdie).","language":37,"languageDescription":"Dutch (Netherlands)"}]}],"principalExclusionCriteria":[{"id":1544869,"number":1,"principalExclusionCriteria":"For FOSTER evolving study platform - 1. Low-grade osteosarcoma, parosteal or periosteal osteosarcoma , small cell osteosarcome","principalExclusionCriteriaTranslations":[{"id":11153158,"uuid":"64661e7f-5154-415e-a4d9-1bf68055a659","attributeTranslation":"Voor het FOSTER onderzoeksplatfom - 1. Laaggradig osteosarcoom, parostaal of periostaal osteosarcoom, kleincellig osteosarcoom","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11153154,"uuid":"64661e7f-5154-415e-a4d9-1bf68055a659","attributeTranslation":"Per lo studio evolutivo della piattaforma FOSTER - 1. Osteosarcoma di basso grado, osteosarcoma parostale o periostale, osteosarcoma a piccole cellule","language":14,"languageDescription":"Italian"},{"id":11153156,"uuid":"64661e7f-5154-415e-a4d9-1bf68055a659","attributeTranslation":"Para la plataforma del estudio FOSTER-evolving - 1. Osteosarcoma de bajo grado, osteosarcoma parosteal o perióstico , osteosarcoma de células pequeñas","language":7,"languageDescription":"Spanish"},{"id":11153157,"uuid":"64661e7f-5154-415e-a4d9-1bf68055a659","attributeTranslation":"De l’étude évolutive plateforme FOSTER - 1. Ostéosarcome de bas grade, ostéosarcome parostéal ou périostéal, ostéosarcome à petites cellules","language":34,"languageDescription":"French (France)"},{"id":11153155,"uuid":"64661e7f-5154-415e-a4d9-1bf68055a659","attributeTranslation":"W ramach badania FOSTER - 1. Kościopochodny mięsak niskiego ryzyka, kostniakomięsak przykostny lub okostnowy, kostniakomięsak drobnokomórkowy","language":19,"languageDescription":"Polish"}]},{"id":1544870,"number":10,"principalExclusionCriteria":"For FOSTER-CabOS (first randomization) - 17. Clinically significant unrelated systemic illness (e.g., serious infection or significant cardiac, pulmonary, hepatic, or other organ dysfunction) that would compromise the patient's ability to tolerate study treatment or would likely interfere with study procedures or results;","principalExclusionCriteriaTranslations":[{"id":11153160,"uuid":"2e8729ca-9c09-43e1-bd93-a663a9e2c6fe","attributeTranslation":"W ramach FOSTER-CabOS (pierwsza randomizacja) - 17. Klinicznie istotna, niezwiązana choroba układowa (np. poważna infekcja lub istotna dysfunkcja serca, płuc, wątroby lub innych narządów), która mogłaby utrudnić pacjentowi tolerancję leczenia badanego lub prawdopodobnie zakłócić procedury lub wyniki badania;","language":19,"languageDescription":"Polish"},{"id":11153161,"uuid":"2e8729ca-9c09-43e1-bd93-a663a9e2c6fe","attributeTranslation":"Per FOSTER-CabOS (prima randomizzazione) - 17. Malattia sistemica non correlata clinicamente significativa (ad esempio, infezione grave o disfunzione cardiaca, polmonare, epatica o di altri organi significativa) che comprometterebbe la capacità del paziente di tollerare il trattamento in studio o che probabilmente interferirebbe con le procedure o i risultati dello studio.","language":14,"languageDescription":"Italian"},{"id":11153163,"uuid":"2e8729ca-9c09-43e1-bd93-a663a9e2c6fe","attributeTranslation":"Para FOSTER-CabOS (primera aleatorización) - 17. Enfermedad sistémica no relacionada clínicamente significativa (por ejemplo, infección grave o disfunción cardíaca, pulmonar, hepática u otra disfunción orgánica significativa) que comprometa la capacidad del paciente para tolerar el tratamiento del estudio o que pueda interferir en los procedimientos o resultados del estudio.","language":7,"languageDescription":"Spanish"},{"id":11153159,"uuid":"2e8729ca-9c09-43e1-bd93-a663a9e2c6fe","attributeTranslation":"Pour FOSTER-CabOS (première randomisation) - 17. Maladie systémique non liée, cliniquement significative (par ex. infection grave ou dysfonction cardiaque, pulmonaire, hépatique ou autre dysfonction d’organe importante) susceptible de compromettre la capacité du patient à tolérer le traitement de l’étude ou d’interférer avec les procédures ou résultats de l’étude.","language":34,"languageDescription":"French (France)"},{"id":11153162,"uuid":"2e8729ca-9c09-43e1-bd93-a663a9e2c6fe","attributeTranslation":"Voor FOSTER-CabOS,(eerste randomisatie) - 17. Klinisch significante niet-gerelateerde systemische ziekte (bv. ernstige infectie of significante hart-, long-, lever- of andere orgaanfunctiestoornis) die het vermogen van de patiënt om de studiebehandeling te verdragen in gevaar zou brengen of die de onderzoeksprocedures of -resultaten waarschijnlijk zou verstoren;","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":1544871,"number":11,"principalExclusionCriteria":"For FOSTER-CabOS (first randomization) - 18. Use of prohibited concomitant and/or concurrent medications (see section “Prohibited concomitant/concurrent treatments)","principalExclusionCriteriaTranslations":[{"id":11153168,"uuid":"815b449c-e54c-4a33-b0ea-b59abb22c108","attributeTranslation":"Pour FOSTER-CabOS (première randomisation) - 18. Utilisation de médicaments concomitants ou simultanés interdits (voir section « Traitements concomitants/simultanés interdits »).","language":34,"languageDescription":"French (France)"},{"id":11153165,"uuid":"815b449c-e54c-4a33-b0ea-b59abb22c108","attributeTranslation":"Para FOSTER-CabOS (primera aleatorización) - 18. Uso de medicamentos concomitantes y/o concurrentes prohibidos (véase la sección «Tratamientos concomitantes/concurrentes prohibidos»).","language":7,"languageDescription":"Spanish"},{"id":11153164,"uuid":"815b449c-e54c-4a33-b0ea-b59abb22c108","attributeTranslation":"Voor FOSTER-CabOS,(eerste randomisatie) - 18. Gebruik van verboden gelijktijdige en/of gelijktijdige medicatie (zie rubriek \"Verboden gelijktijdige/gelijktijdige behandelingen)","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11153166,"uuid":"815b449c-e54c-4a33-b0ea-b59abb22c108","attributeTranslation":"W ramach FOSTER-CabOS (pierwsza randomizacja) - 18. Stosowanie zabronionych leków jednocześnie i/lub równolegle (patrz punkt „Zabronione leki jednocześnie/równoczesne”)","language":19,"languageDescription":"Polish"},{"id":11153167,"uuid":"815b449c-e54c-4a33-b0ea-b59abb22c108","attributeTranslation":"Per FOSTER-CabOS (prima randomizzazione) - 18. Uso di farmaci concomitanti e/o concorrenti proibiti (vedere la sezione “Trattamenti concomitanti/concorrenti proibiti”).","language":14,"languageDescription":"Italian"}]},{"id":1544872,"number":12,"principalExclusionCriteria":"For FOSTER-CabOS (first randomization) - 1. Progressive disease at any site during initial pre- and/or post-operative chemotherapy, confirmed before randomisation time. With exception of patients with progressive disease limited to the primary tumour during pre-operative chemotherapy, if complete resection is achieved at surgery.","principalExclusionCriteriaTranslations":[{"id":11153173,"uuid":"0719178e-111c-406a-a3e1-5911bbb4ca7b","attributeTranslation":"Para FOSTER-CabOS (primera aleatorización) - 1. Enfermedad progresiva en cualquier localización durante la quimioterapia inicial preoperatoria y/o posoperatoria, confirmada antes del momento de la aleatorización. Con excepción de los pacientes con enfermedad progresiva limitada al tumor primario durante la quimioterapia preoperatoria, si se logra la resección completa en la cirugía.","language":7,"languageDescription":"Spanish"},{"id":11153172,"uuid":"0719178e-111c-406a-a3e1-5911bbb4ca7b","attributeTranslation":"Voor FOSTER-CabOS,(eerste randomisatie) - 1. Progressieve ziekte op enige plaats tijdens de initiële pre- en/of postoperatieve chemotherapie, bevestigd vóór het moment van randomisatie. Met uitzondering van patiënten met progressieve ziekte beperkt tot de primaire tumor tijdens pre-operatieve chemotherapie, indien volledige resectie is bereikt tijdens de operatie.","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11153169,"uuid":"0719178e-111c-406a-a3e1-5911bbb4ca7b","attributeTranslation":"Per FOSTER-CabOS (prima randomizzazione) - 1. Progressione della malattia in qualsiasi sede durante la chemioterapia iniziale pre e/o post-operatoria, confermata prima della randomizzazione. Ad eccezione dei pazienti con progressione limitata al tumore primario durante la chemioterapia pre-operatoria, se si ottiene una resezione completa durante l'intervento chirurgico.","language":14,"languageDescription":"Italian"},{"id":11153171,"uuid":"0719178e-111c-406a-a3e1-5911bbb4ca7b","attributeTranslation":"Pour FOSTER-CabOS (première randomisation) - 1. Maladie progressive à n’importe quel site pendant la chimiothérapie initiale pré‑ et/ou postopératoire, confirmée avant la randomisation.\nException : les patients ayant une progression limitée à la tumeur primitive pendant la chimiothérapie préopératoire, si une résection complète est réalisée lors de la chirurgie.","language":34,"languageDescription":"French (France)"},{"id":11153170,"uuid":"0719178e-111c-406a-a3e1-5911bbb4ca7b","attributeTranslation":"W ramach FOSTER-CabOS (pierwsza randomizacja) - 1. Progresja choroby w dowolnym miejscu podczas wstępnej chemioterapii przedoperacyjnej i/lub pooperacyjnej, potwierdzony przed randomizacją. Z wyjątkiem pacjentów z postępem choroby ograniczonym do guza pierwotnego podczas chemioterapii przedoperacyjnej, jeśli całkowita resekcja zostanie osiągnięta podczas operacji.","language":19,"languageDescription":"Polish"}]},{"id":1544873,"number":13,"principalExclusionCriteria":"For FOSTER-CabOS (first randomization) - 19. Pregnant or breastfeeding women or intending to become pregnant during the clinical investigation.","principalExclusionCriteriaTranslations":[{"id":11153177,"uuid":"995e1e28-88b0-4c88-8344-46138bccd851","attributeTranslation":"Para FOSTER-CabOS (primera aleatorización) - 19. Mujeres embarazadas o en período de lactancia, o que tengan intención de quedarse embarazadas durante la investigación clínica.","language":7,"languageDescription":"Spanish"},{"id":11153178,"uuid":"995e1e28-88b0-4c88-8344-46138bccd851","attributeTranslation":"Pour FOSTER-CabOS (première randomisation) - 19. Femmes enceintes ou allaitantes ou ayant l'intention de tomber enceinte pendant l'étude clinique.","language":34,"languageDescription":"French (France)"},{"id":11153174,"uuid":"995e1e28-88b0-4c88-8344-46138bccd851","attributeTranslation":"W ramach FOSTER-CabOS (pierwsza randomizacja) - 19. Kobiety w ciąży lub karmiące piersią lub zamierzające zajść w ciążę w trakcie trwania badania klinicznego.","language":19,"languageDescription":"Polish"},{"id":11153175,"uuid":"995e1e28-88b0-4c88-8344-46138bccd851","attributeTranslation":"Per FOSTER-CabOS (prima randomizzazione) - 19. Donne in gravidanza o in allattamento o che intendono rimanere incinte durante la sperimentazione clinica.","language":14,"languageDescription":"Italian"},{"id":11153176,"uuid":"995e1e28-88b0-4c88-8344-46138bccd851","attributeTranslation":"Voor FOSTER-CabOS,(eerste randomisatie) - 19. Zwangere vrouwen of vrouwen die borstvoeding geven of van plan zijn zwanger te worden tijdens het klinisch onderzoek.","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":1544874,"number":14,"principalExclusionCriteria":"For FOSTER-CabOS (first randomization) - 20. Patients with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial","principalExclusionCriteriaTranslations":[{"id":11153180,"uuid":"ff5fb255-ecf6-48e7-8b03-1ca115e41e2e","attributeTranslation":"Para FOSTER-CabOS (primera aleatorización) -20. Pacientes con cualquier condición psicológica, familiar, sociológica o geográfica que pueda dificultar el cumplimiento del protocolo del estudio y el calendario de seguimiento; dichas condiciones deben discutirse con el paciente antes de su inscripción en el ensayo.","language":7,"languageDescription":"Spanish"},{"id":11153181,"uuid":"ff5fb255-ecf6-48e7-8b03-1ca115e41e2e","attributeTranslation":"Pour FOSTER-CabOS (première randomisation) - 20. Patients présentant des conditions psychologiques, familiales, sociologiques ou géographiques susceptibles d'entraver le respect du protocole de l'étude et du calendrier de suivi ; ces conditions doivent être discutées avec le patient avant l'inscription à l'essai","language":34,"languageDescription":"French (France)"},{"id":11153182,"uuid":"ff5fb255-ecf6-48e7-8b03-1ca115e41e2e","attributeTranslation":"Per FOSTER-CabOS (prima randomizzazione) - 20. Pazienti con qualsiasi condizione psicologica, familiare, sociologica o geografica che possa potenzialmente ostacolare il rispetto del protocollo dello studio e del programma di follow-up; tali condizioni devono essere discusse con il paziente prima della registrazione nella sperimentazione.","language":14,"languageDescription":"Italian"},{"id":11153179,"uuid":"ff5fb255-ecf6-48e7-8b03-1ca115e41e2e","attributeTranslation":"W ramach FOSTER-CabOS (pierwsza randomizacja) - 20. Pacjenci z jakimikolwiek uwarunkowaniami psychologicznymi, rodzinnymi, socjologicznymi lub geograficznymi, które potencjalnie mogą utrudniać przestrzeganie protokołu badania i harmonogramu obserwacji; uwarunkowania te należy omówić z pacjentem przed włączeniem do badania","language":19,"languageDescription":"Polish"},{"id":11153183,"uuid":"ff5fb255-ecf6-48e7-8b03-1ca115e41e2e","attributeTranslation":"Voor FOSTER-CabOS,(eerste randomisatie) - 20. Patiënten met psychologische, familiale, sociologische of geografische aandoeningen die de naleving van het studieprotocol en het follow-upschema kunnen belemmeren; deze aandoeningen moeten met de patiënt worden besproken voordat hij/zij zich inschrijft voor het onderzoek;","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":1544875,"number":15,"principalExclusionCriteria":"For FOSTER-CabOS (first randomization) - 21. Patients with history of non-compliance to medical regimens or unwilling or unable to comply with the protocol.","principalExclusionCriteriaTranslations":[{"id":11153184,"uuid":"8c34c1c5-08ad-4ece-acfb-aa2f26b21ee4","attributeTranslation":"Pour FOSTER-CabOS (première randomisation) - 21. Les patients ayant des antécédents de non-respect des traitements médicaux ou ne voulant pas ou ne pouvant pas se conformer au protocole.","language":34,"languageDescription":"French (France)"},{"id":11153187,"uuid":"8c34c1c5-08ad-4ece-acfb-aa2f26b21ee4","attributeTranslation":"W ramach FOSTER-CabOS (pierwsza randomizacja) - 21. Pacjenci z historią nieprzestrzegania schematów leczenia lub niechętni lub niezdolni do przestrzegania protokołu.","language":19,"languageDescription":"Polish"},{"id":11153185,"uuid":"8c34c1c5-08ad-4ece-acfb-aa2f26b21ee4","attributeTranslation":"Para FOSTER-CabOS (primera aleatorización) - 21. Pacientes con antecedentes de incumplimiento de los regímenes médicos o que no estén dispuestos o no puedan cumplir con el protocolo.","language":7,"languageDescription":"Spanish"},{"id":11153186,"uuid":"8c34c1c5-08ad-4ece-acfb-aa2f26b21ee4","attributeTranslation":"Voor FOSTER-CabOS,(eerste randomisatie) - 21. Patiënten met een voorgeschiedenis van het niet naleven van medische regimes of die niet willen of kunnen voldoen aan het protocol.","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11153188,"uuid":"8c34c1c5-08ad-4ece-acfb-aa2f26b21ee4","attributeTranslation":"Per FOSTER-CabOS (prima randomizzazione) - 21. Pazienti con una storia di non aderenza ai regimi medici o che non vogliono o non sono in grado di rispettare il protocollo.","language":14,"languageDescription":"Italian"}]},{"id":1544876,"number":16,"principalExclusionCriteria":"For FOSTER-CabOS (first randomization) - 22. Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent","principalExclusionCriteriaTranslations":[{"id":11153191,"uuid":"d7806955-372d-47d2-a08e-5aef25ebd661","attributeTranslation":"W ramach FOSTER-CabOS (pierwsza randomizacja) - 22. Pacjenci ubezwłasnowolnieni lub pozbawieni wolności na mocy decyzji sądowej lub administracyjnej lub niezdolni do wyrażenia zgody.","language":19,"languageDescription":"Polish"},{"id":11153192,"uuid":"d7806955-372d-47d2-a08e-5aef25ebd661","attributeTranslation":"Per FOSTER-CabOS (prima randomizzazione) - 22. Paziente sotto tutela o privato della libertà personale da una decisione giudiziaria o amministrativa o incapace di dare il proprio consenso.","language":14,"languageDescription":"Italian"},{"id":11153193,"uuid":"d7806955-372d-47d2-a08e-5aef25ebd661","attributeTranslation":"Voor FOSTER-CabOS,(eerste randomisatie) - 22. Patiënt die onder curatele staat of van zijn vrijheid is beroofd door een gerechtelijke of administratieve beslissing of wilsonbekwaam","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11153190,"uuid":"d7806955-372d-47d2-a08e-5aef25ebd661","attributeTranslation":"Pour FOSTER-CabOS (première randomisation) - 22. Patient sous tutelle ou privé de sa liberté par une décision judiciaire ou administrative ou incapable de donner son consentement.","language":34,"languageDescription":"French (France)"},{"id":11153189,"uuid":"d7806955-372d-47d2-a08e-5aef25ebd661","attributeTranslation":"Para FOSTER-CabOS (primera aleatorización) - 22. Paciente bajo tutela o privado de su libertad por decisión judicial o administrativa, o incapaz de dar su consentimiento.","language":7,"languageDescription":"Spanish"}]},{"id":1544877,"number":17,"principalExclusionCriteria":"For FOSTER-CabOS (first randomization) - 2. Prior treatment with any Vascular Endothelial Growth Factor (VEGFR) inhibitor (thus, any prior exposure to sunitinib, sorafenib, pazopanib, regorafenib, bevacizumab, or other VEGFR inhibitor);","principalExclusionCriteriaTranslations":[{"id":11153197,"uuid":"d6e166a9-abd0-43fc-923f-0ca2377c2be6","attributeTranslation":"Per FOSTER-CabOS (prima randomizzazione) - 2. Precedente trattamento con qualsiasi inibitore del fattore di crescita endoteliale vascolare (VEGFR) (quindi, qualsiasi precedente esposizione a sunitinib, sorafenib, pazopanib, regorafenib, bevacizumab o altri inibitori del VEGFR).","language":14,"languageDescription":"Italian"},{"id":11153194,"uuid":"d6e166a9-abd0-43fc-923f-0ca2377c2be6","attributeTranslation":"Para FOSTER-CabOS (primera aleatorización) - 2. Tratamiento previo con cualquier inhibidor del factor de crecimiento endotelial vascular (VEGFR) (es decir, cualquier exposición previa a sunitinib, sorafenib, pazopanib, regorafenib, bevacizumab u otro inhibidor del VEGFR).","language":7,"languageDescription":"Spanish"},{"id":11153195,"uuid":"d6e166a9-abd0-43fc-923f-0ca2377c2be6","attributeTranslation":"Voor FOSTER-CabOS,(eerste randomisatie) - 2. Voorafgaande behandeling met een VEGFR-remmer (Vascular Endothelial Growth Factor) (dus voorafgaande blootstelling aan sunitinib, sorafenib, pazopanib, regorafenib, bevacizumab of een andere VEGFR-remmer);","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11153196,"uuid":"d6e166a9-abd0-43fc-923f-0ca2377c2be6","attributeTranslation":"W ramach FOSTER-CabOS (pierwsza randomizacja) - 2. Wcześniejsze leczenie jakimkolwiek inhibitorem czynnika wzrostu śródbłonka naczyniowego (VEGFR) (a zatem jakakolwiek wcześniejsza ekspozycja na sunitynib, sorafenib, pazopanib, regorafenib, bewacyzumab lub inny inhibitor VEGFR);","language":19,"languageDescription":"Polish"},{"id":11153198,"uuid":"d6e166a9-abd0-43fc-923f-0ca2377c2be6","attributeTranslation":"Pour FOSTER-CabOS (première randomisation) - 2. Traitement antérieur par un inhibiteur du VEGFR (y compris toute exposition au sunitinib, sorafénib, pazopanib, régorafénib, bévacizumab ou tout autre inhibiteur du VEGFR).","language":34,"languageDescription":"French (France)"}]},{"id":1544878,"number":18,"principalExclusionCriteria":"For FOSTER-CabOS (first randomization) - 3. Cardiovascular dysfunction","principalExclusionCriteriaTranslations":[{"id":11153202,"uuid":"e9280877-3b1e-4ce6-a2a4-3e27183da0fd","attributeTranslation":"Voor FOSTER-CabOS,(eerste randomisatie) - 3. Cardiovasculaire disfunctie","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11153201,"uuid":"e9280877-3b1e-4ce6-a2a4-3e27183da0fd","attributeTranslation":"Per FOSTER-CabOS (prima randomizzazione) - 3. Disfunzione cardiovascolare","language":14,"languageDescription":"Italian"},{"id":11153203,"uuid":"e9280877-3b1e-4ce6-a2a4-3e27183da0fd","attributeTranslation":"Pour FOSTER-CabOS (première randomisation) - 3. Dysfonction cardiovasculaire","language":34,"languageDescription":"French (France)"},{"id":11153199,"uuid":"e9280877-3b1e-4ce6-a2a4-3e27183da0fd","attributeTranslation":"W ramach FOSTER-CabOS (pierwsza randomizacja) - 3. Dysfunkcja układu sercowo-naczyniowego","language":19,"languageDescription":"Polish"},{"id":11153200,"uuid":"e9280877-3b1e-4ce6-a2a4-3e27183da0fd","attributeTranslation":"Para FOSTER-CabOS (primera aleatorización) - 3. Disfunción cardiovascular","language":7,"languageDescription":"Spanish"}]},{"id":1544879,"number":19,"principalExclusionCriteria":"For FOSTER-CabOS (first randomization) - 4. Uncontrolled hypertension > the 95th percentile despite optimal treatment (for adults, systolic blood pressure > 150mmHg or diastolic pressure > 90 mmHg despite optimal treatment)","principalExclusionCriteriaTranslations":[{"id":11153204,"uuid":"1151fb14-8211-461b-a0ec-392841b3849e","attributeTranslation":"W ramach FOSTER-CabOS (pierwsza randomizacja) - 4. Niekontrolowane nadciśnienie tętnicze > 95. percentyla pomimo optymalnego leczenia (u dorosłych ciśnienie skurczowe > 150 mmHg lub ciśnienie rozkurczowe > 90 mmHg pomimo optymalnego leczenia)","language":19,"languageDescription":"Polish"},{"id":11153206,"uuid":"1151fb14-8211-461b-a0ec-392841b3849e","attributeTranslation":"Para FOSTER-CabOS (primera aleatorización) - 4. Hipertensión no controlada > percentil 95 a pesar de un tratamiento óptimo (para adultos, presión arterial sistólica > 150 mmHg o presión diastólica > 90 mmHg a pesar de un tratamiento óptimo).","language":7,"languageDescription":"Spanish"},{"id":11153205,"uuid":"1151fb14-8211-461b-a0ec-392841b3849e","attributeTranslation":"Per FOSTER-CabOS (prima randomizzazione) - 4. Ipertensione incontrollata > 95° percentile nonostante il trattamento ottimale (per gli adulti, pressione sanguigna sistolica > 150 mmHg o pressione diastolica > 90 mmHg nonostante il trattamento ottimale).","language":14,"languageDescription":"Italian"},{"id":11153207,"uuid":"1151fb14-8211-461b-a0ec-392841b3849e","attributeTranslation":"Pour FOSTER-CabOS (première randomisation) - 4. Hypertension non contrôlée > 95e percentile malgré traitement optimal\n(pour les adultes : pression systolique > 150 mmHg ou diastolique > 90 mmHg).","language":34,"languageDescription":"French (France)"},{"id":11153208,"uuid":"1151fb14-8211-461b-a0ec-392841b3849e","attributeTranslation":"Voor FOSTER-CabOS,(eerste randomisatie) - 4. Ongecontroleerde hypertensie > het 95e percentiel ondanks optimale behandeling (voor volwassenen, systolische bloeddruk > 150 mmHg of diastolische druk > 90 mmHg ondanks optimale behandeling);","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":1544880,"number":2,"principalExclusionCriteria":"For FOSTER-CabOS (first randomization) - 9. Active hepatitis B or C or chronic hepatitis B or C requiring treatment with antiviral therapy;","principalExclusionCriteriaTranslations":[{"id":11153210,"uuid":"5029cc7f-a83f-4be4-926b-90bbe3bfe39e","attributeTranslation":"Para FOSTER-CabOS (primera aleatorización) - 9. Hepatitis B o C activa o hepatitis B o C crónica que requiera tratamiento con terapia antiviral.","language":7,"languageDescription":"Spanish"},{"id":11153212,"uuid":"5029cc7f-a83f-4be4-926b-90bbe3bfe39e","attributeTranslation":"Per FOSTER-CabOS (prima randomizzazione) - 9. Epatite B o C attiva o cronica che richiede trattamento con terapia antivirale.","language":14,"languageDescription":"Italian"},{"id":11153211,"uuid":"5029cc7f-a83f-4be4-926b-90bbe3bfe39e","attributeTranslation":"W ramach FOSTER-CabOS (pierwsza randomizacja) - 9. Aktywne wirusowe zapalenie wątroby typu B lub C albo przewlekłe wirusowe zapalenie wątroby typu B lub C wymagające leczenia przeciwwirusowego;","language":19,"languageDescription":"Polish"},{"id":11153213,"uuid":"5029cc7f-a83f-4be4-926b-90bbe3bfe39e","attributeTranslation":"Pour FOSTER-CabOS (première randomisation) - 9. Hépatite B ou C active, ou hépatite B ou C chronique nécessitant un traitement antiviral.","language":34,"languageDescription":"French (France)"},{"id":11153209,"uuid":"5029cc7f-a83f-4be4-926b-90bbe3bfe39e","attributeTranslation":"Voor FOSTER-CabOS,(eerste randomisatie) - 9. Actieve hepatitis B of C of chronische hepatitis B of C waarvoor behandeling met antivirale therapie nodig is","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":1544881,"number":20,"principalExclusionCriteria":"For FOSTER-CabOS (first randomization) - 5. Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism within the last 6 months before the first study drug administration;","principalExclusionCriteriaTranslations":[{"id":11153217,"uuid":"ae8689aa-5179-4d11-ac3b-e49aab3da721","attributeTranslation":"Pour FOSTER-CabOS (première randomisation) - 5. Événements thrombotiques ou emboliques artériels ou veineux dans les 6 derniers mois : accident vasculaire cérébral (y compris AIT), thrombose veineuse profonde, embolie pulmonaire.","language":34,"languageDescription":"French (France)"},{"id":11153214,"uuid":"ae8689aa-5179-4d11-ac3b-e49aab3da721","attributeTranslation":"Per FOSTER-CabOS (prima randomizzazione) - 5. Eventi trombotici arteriosi o venosi o eventi embolici quali accidenti cerebrovascolari (inclusi attacchi ischemici transitori), trombosi venosa profonda o embolia polmonare negli ultimi 6 mesi prima della prima somministrazione del farmaco in studio.","language":14,"languageDescription":"Italian"},{"id":11153216,"uuid":"ae8689aa-5179-4d11-ac3b-e49aab3da721","attributeTranslation":"Para FOSTER-CabOS (primera aleatorización) - 5. Eventos trombóticos o embólicos arteriales o venosos, como accidente cerebrovascular (incluidos los accidentes isquémicos transitorios), trombosis venosa profunda o embolia pulmonar en los últimos 6 meses antes de la primera administración del fármaco del estudio.","language":7,"languageDescription":"Spanish"},{"id":11153215,"uuid":"ae8689aa-5179-4d11-ac3b-e49aab3da721","attributeTranslation":"Voor FOSTER-CabOS,(eerste randomisatie) - 5. Arteriële of veneuze trombotische of embolische voorvallen zoals cerebrovasculair accident (inclusief voorbijgaande ischemische aanvallen), diepe veneuze trombose of longembolie binnen de laatste 6 maanden voor de eerste toediening van het studiemedicijn;","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11153218,"uuid":"ae8689aa-5179-4d11-ac3b-e49aab3da721","attributeTranslation":"W ramach FOSTER-CabOS (pierwsza randomizacja) - 5. Tętnicze lub żylne zdarzenia zakrzepowe lub zatorowe, takie jak udar mózgu (w tym przemijające napady niedokrwienne), zakrzepica żył głębokich lub zatorowość płucna w ciągu ostatnich 6 miesięcy przed pierwszym podaniem leku badanego;","language":19,"languageDescription":"Polish"}]},{"id":1544882,"number":21,"principalExclusionCriteria":"For FOSTER-CabOS (first randomization) - 6. Major surgical procedure or significant traumatic injury within 3 weeks before the first study drug administration. Note: Adequate wound healing after major surgery must be clinically assessed, independent of time elapsed for eligibility.","principalExclusionCriteriaTranslations":[{"id":11153223,"uuid":"b202a362-d965-4a04-81b4-321360a4b463","attributeTranslation":"Voor FOSTER-CabOS,(eerste randomisatie) - 6. Belangrijke chirurgische ingreep of significant traumatisch letsel binnen 3 weken voor de eerste toediening van het studiemedicijn. Opmerking: Adequate wondgenezing na een grote operatie moet klinisch worden beoordeeld, onafhankelijk van de verstreken tijd om in aanmerking te komen.","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11153221,"uuid":"b202a362-d965-4a04-81b4-321360a4b463","attributeTranslation":"Per FOSTER-CabOS (prima randomizzazione) - 6. Intervento chirurgico importante o lesione traumatica significativa nelle 3 settimane precedenti la prima somministrazione del farmaco in studio. Nota: l'adeguata guarigione della ferita dopo un intervento chirurgico importante deve essere valutata clinicamente, indipendentemente dal tempo trascorso ai fini della eleggibilità.","language":14,"languageDescription":"Italian"},{"id":11153220,"uuid":"b202a362-d965-4a04-81b4-321360a4b463","attributeTranslation":"W ramach FOSTER-CabOS (pierwsza randomizacja) - 6. Poważny zabieg chirurgiczny lub poważny uraz w ciągu 3 tygodni przed pierwszym podaniem leku badanego. Uwaga: Prawidłowe gojenie się ran po dużym zabiegu chirurgicznym musi zostać ocenione klinicznie, niezależnie od czasu, jaki upłynął od momentu kwalifikacji.","language":19,"languageDescription":"Polish"},{"id":11153222,"uuid":"b202a362-d965-4a04-81b4-321360a4b463","attributeTranslation":"Para FOSTER-CabOS (primera aleatorización) - 6. Intervención quirúrgica mayor o lesión traumática significativa en las 3 semanas anteriores a la primera administración del fármaco del estudio. Nota: La cicatrización adecuada de la herida después de una cirugía mayor debe evaluarse clínicamente, independientemente del tiempo transcurrido para la elegibilidad.","language":7,"languageDescription":"Spanish"},{"id":11153219,"uuid":"b202a362-d965-4a04-81b4-321360a4b463","attributeTranslation":"Pour FOSTER-CabOS (première randomisation) - 6. Procédure chirurgicale majeure ou traumatisme important survenu dans les 3 semaines précédant la première administration du médicament de l’étude. Note : la guérison adéquate de la plaie après une chirurgie majeure doit être évaluée cliniquement, indépendamment du délai écoulé pour déterminer l'éligibilité.","language":34,"languageDescription":"French (France)"}]},{"id":1544883,"number":22,"principalExclusionCriteria":"For FOSTER-CabOS (first randomization) - 7. Ongoing infection > Grade 2 according to NCI-CTCAE v5, unless fully recovered prior cycle1 day1;","principalExclusionCriteriaTranslations":[{"id":11153224,"uuid":"2edc1865-bb26-4724-84b7-5b55cabcc622","attributeTranslation":"Per FOSTER-CabOS (prima randomizzazione) - 7. Infezione in corso > Grado 2 secondo NCI-CTCAE v5, a meno che non sia completamente guarita prima del giorno 1 del ciclo 1.","language":14,"languageDescription":"Italian"},{"id":11153226,"uuid":"2edc1865-bb26-4724-84b7-5b55cabcc622","attributeTranslation":"Pour FOSTER-CabOS (première randomisation) - 7. Infection en cours > Grade 2 selon le NCI‑CTCAE v5, sauf si complètement guérie avant le jour 1 du cycle 1.","language":34,"languageDescription":"French (France)"},{"id":11153227,"uuid":"2edc1865-bb26-4724-84b7-5b55cabcc622","attributeTranslation":"Para FOSTER-CabOS (primera aleatorización) - 7. Infección en curso > grado 2 según NCI-CTCAE v5, a menos que se haya recuperado completamente antes del ciclo anterior, día 1.","language":7,"languageDescription":"Spanish"},{"id":11153225,"uuid":"2edc1865-bb26-4724-84b7-5b55cabcc622","attributeTranslation":"Voor FOSTER-CabOS,(eerste randomisatie) - 7. Lopende infectie > graad 2 volgens NCI-CTCAE v5, tenzij volledig hersteld vóór cyclus1 dag1;","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11153228,"uuid":"2edc1865-bb26-4724-84b7-5b55cabcc622","attributeTranslation":"W ramach FOSTER-CabOS (pierwsza randomizacja) - 7. Trwające zakażenie > stopnia 2 według NCI-CTCAE v5, chyba że całkowite wyleczenie nastąpiło przed 1. dniem cyklu;","language":19,"languageDescription":"Polish"}]},{"id":1544884,"number":23,"principalExclusionCriteria":"For FOSTER-CabOS (first randomization) - 8. Known history of human immunodeficiency virus (HIV) infection;","principalExclusionCriteriaTranslations":[{"id":11153230,"uuid":"3c2badf2-c6df-436f-a3a9-38c0fd2828ea","attributeTranslation":"Per FOSTER-CabOS (prima randomizzazione) - 8. Storia nota di infezione da virus dell'immunodeficienza umana (HIV).","language":14,"languageDescription":"Italian"},{"id":11153229,"uuid":"3c2badf2-c6df-436f-a3a9-38c0fd2828ea","attributeTranslation":"Pour FOSTER-CabOS (première randomisation) - 8. Antécédents connus d’infection par le virus de l’immunodéficience humaine (VIH).","language":34,"languageDescription":"French (France)"},{"id":11153231,"uuid":"3c2badf2-c6df-436f-a3a9-38c0fd2828ea","attributeTranslation":"Para FOSTER-CabOS (primera aleatorización) - 8. Antecedentes conocidos de infección por el virus de la inmunodeficiencia humana (VIH).","language":7,"languageDescription":"Spanish"},{"id":11153233,"uuid":"3c2badf2-c6df-436f-a3a9-38c0fd2828ea","attributeTranslation":"Voor FOSTER-CabOS,(eerste randomisatie) - 8. Bekende voorgeschiedenis van infectie met het humaan immunodeficiëntievirus (HIV)","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11153232,"uuid":"3c2badf2-c6df-436f-a3a9-38c0fd2828ea","attributeTranslation":"W ramach FOSTER-CabOS (pierwsza randomizacja) - 8. Znane zakażenie wirusem niedoboru odporności ludzkiej (HIV);","language":19,"languageDescription":"Polish"}]},{"id":1544885,"number":24,"principalExclusionCriteria":"For FOSTER-CabOS (first randomization) -23. Known hypersensitivity to the active substance Investigational Medicinal Product or to any of the excipients","principalExclusionCriteriaTranslations":[{"id":11153237,"uuid":"2c4b03c8-0414-4b5b-bc01-c8ebdab8e8a0","attributeTranslation":"Voor FOSTER-CabOS,(eerste randomisatie) - 23. Bekende overgevoeligheid voor de werkzame stof van het onderzoeksgeneesmiddel of voor een van de hulpstoffen.","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11153235,"uuid":"2c4b03c8-0414-4b5b-bc01-c8ebdab8e8a0","attributeTranslation":"Per FOSTER-CabOS (prima randomizzazione) - 23. Ipersensibilità nota al principio attivo del medicinale sperimentale o ad uno qualsiasi degli eccipienti","language":14,"languageDescription":"Italian"},{"id":11153236,"uuid":"2c4b03c8-0414-4b5b-bc01-c8ebdab8e8a0","attributeTranslation":"W ramach FOSTER-CabOS (pierwsza randomizacja) - 23. Znana nadwrażliwość na substancję czynną badanego produktu leczniczego lub na którąkolwiek substancję pomocniczą.","language":19,"languageDescription":"Polish"},{"id":11153234,"uuid":"2c4b03c8-0414-4b5b-bc01-c8ebdab8e8a0","attributeTranslation":"Pour FOSTER-CabOS (première randomisation) - 23. Hypersensibilité connue au principe actif du médicament expérimental ou à l'un des excipients.","language":34,"languageDescription":"French (France)"},{"id":11153238,"uuid":"2c4b03c8-0414-4b5b-bc01-c8ebdab8e8a0","attributeTranslation":"Per FOSTER-CabOS (prima randomizzazione) - 23. Hipersensibilidad conocida al principio activo del medicamento en investigación o a cualquiera de los excipientes.","language":7,"languageDescription":"Spanish"}]},{"id":1544886,"number":3,"principalExclusionCriteria":"For FOSTER-CabOS (first randomization) - 10. Dehydration according to NCI-CTC v5 Grade >1","principalExclusionCriteriaTranslations":[{"id":11153243,"uuid":"6329167b-51fe-4bd9-abd1-64004959d38d","attributeTranslation":"Per FOSTER-CabOS (prima randomizzazione) - 10. Disidratazione secondo NCI-CTC v5 Grado >1.","language":14,"languageDescription":"Italian"},{"id":11153239,"uuid":"6329167b-51fe-4bd9-abd1-64004959d38d","attributeTranslation":"Voor FOSTER-CabOS,(eerste randomisatie) - 10. Dehydratie volgens NCI-CTC v5 Graad >1","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11153242,"uuid":"6329167b-51fe-4bd9-abd1-64004959d38d","attributeTranslation":"Pour FOSTER-CabOS (première randomisation) - 10. Déshydratation > Grade 1 selon le NCI‑CTC v5.","language":34,"languageDescription":"French (France)"},{"id":11153241,"uuid":"6329167b-51fe-4bd9-abd1-64004959d38d","attributeTranslation":"Para FOSTER-CabOS (primera aleatorización) - 10. Deshidratación según NCI-CTC v5 grado >1.","language":7,"languageDescription":"Spanish"},{"id":11153240,"uuid":"6329167b-51fe-4bd9-abd1-64004959d38d","attributeTranslation":"W ramach FOSTER-CabOS (pierwsza randomizacja) - 10. Odwodnienie według NCI-CTC v5 stopnia > 1;","language":19,"languageDescription":"Polish"}]},{"id":1544887,"number":4,"principalExclusionCriteria":"For FOSTER-CabOS (first randomization) - 11. Difficulties to swallow oral medication and/or any malabsorption condition and/or any Gastrointestinal (GI) disease that may significantly alter the absorption of cabozantinib (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhoea, malabsorption syndrome, or small bowel resection);","principalExclusionCriteriaTranslations":[{"id":11153245,"uuid":"98ca7ace-be95-47fe-8f22-fbe459a15461","attributeTranslation":"W ramach FOSTER-CabOS (pierwsza randomizacja) - 11. Trudności z połykaniem leków doustnych i/lub jakiekolwiek schorzenie związane z zespołem złego wchłaniania i/lub jakakolwiek choroba przewodu pokarmowego, która może znacząco wpływać na wchłanianie kabozantynibu (np. choroba wrzodowa, niekontrolowane nudności, wymioty, biegunka, zespół złego wchłaniania lub resekcja jelita cienkiego);","language":19,"languageDescription":"Polish"},{"id":11153246,"uuid":"98ca7ace-be95-47fe-8f22-fbe459a15461","attributeTranslation":"Voor FOSTER-CabOS,(eerste randomisatie) - 11. Moeilijkheden met het slikken van orale medicatie en/of een opnameaandoening en/of een gastro-intestinale (GI) ziekte die de opname van cabozantinib aanzienlijk kan wijzigen (bijv. ulceratieve ziekten, ongecontroleerde misselijkheid, braken, diarree, opnamesyndroom of dunne darmresectie);","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11153247,"uuid":"98ca7ace-be95-47fe-8f22-fbe459a15461","attributeTranslation":"Per FOSTER-CabOS (prima randomizzazione) - 11. Difficoltà a deglutire farmaci orali e/o qualsiasi condizione di malassorbimento e/o qualsiasi malattia gastrointestinale (GI) che possa alterare significativamente l'assorbimento di Cabozantinib (ad esempio, malattie ulcerose, nausea incontrollata, vomito, diarrea, sindrome da malassorbimento o resezione dell'intestino tenue).","language":14,"languageDescription":"Italian"},{"id":11153244,"uuid":"98ca7ace-be95-47fe-8f22-fbe459a15461","attributeTranslation":"Pour FOSTER-CabOS (première randomisation) - 11. Difficultés à avaler un médicament oral et/ou toute condition de malabsorption et/ou toute maladie gastro-intestinale pouvant modifier de manière significative l’absorption du cabozantinib (par ex. ulcérations, nausées incontrôlées, vomissements, diarrhées, syndrome de malabsorption ou résection de l’intestin grêle).","language":34,"languageDescription":"French (France)"},{"id":11153248,"uuid":"98ca7ace-be95-47fe-8f22-fbe459a15461","attributeTranslation":"Para FOSTER-CabOS (primera aleatorización) - 11. Dificultades para tragar medicamentos por vía oral y/o cualquier trastorno de malabsorción y/o cualquier enfermedad gastrointestinal (GI) que pueda alterar significativamente la absorción de cabozantinib (por ejemplo, enfermedades ulcerosas, náuseas incontroladas, vómitos, diarrea, síndrome de malabsorción o resección del intestino delgado).","language":7,"languageDescription":"Spanish"}]},{"id":1544888,"number":5,"principalExclusionCriteria":"For FOSTER-CabOS (first randomization) - 12. Patients with a seizure disorder requiring medication;","principalExclusionCriteriaTranslations":[{"id":11153249,"uuid":"f3caa97e-fabb-478a-80a8-ec1bfe434a88","attributeTranslation":"Voor FOSTER-CabOS,(eerste randomisatie) - 12. Patiënten met een toevalstoornis die medicatie nodig heeft","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11153250,"uuid":"f3caa97e-fabb-478a-80a8-ec1bfe434a88","attributeTranslation":"Para FOSTER-CabOS (primera aleatorización) - 12. Pacientes con un trastorno convulsivo que requiera medicación.","language":7,"languageDescription":"Spanish"},{"id":11153251,"uuid":"f3caa97e-fabb-478a-80a8-ec1bfe434a88","attributeTranslation":"W ramach FOSTER-CabOS (pierwsza randomizacja) - 12. Pacjenci z zaburzeniami padaczkowymi wymagającymi leczenia;","language":19,"languageDescription":"Polish"},{"id":11153252,"uuid":"f3caa97e-fabb-478a-80a8-ec1bfe434a88","attributeTranslation":"Pour FOSTER-CabOS (première randomisation) - 12. Patients présentant un trouble convulsif nécessitant un traitement.","language":34,"languageDescription":"French (France)"},{"id":11153253,"uuid":"f3caa97e-fabb-478a-80a8-ec1bfe434a88","attributeTranslation":"Per FOSTER-CabOS (prima randomizzazione) - 12. Pazienti con disturbi convulsivi che necessitano di farmaci.","language":14,"languageDescription":"Italian"}]},{"id":1544889,"number":6,"principalExclusionCriteria":"For FOSTER-CabOS (first randomization) - 13. Interstitial lung disease with ongoing signs and symptoms at the time of informed consent;","principalExclusionCriteriaTranslations":[{"id":11153256,"uuid":"3dd59740-da2e-499d-8bb0-a47dbdb6ca69","attributeTranslation":"W ramach FOSTER-CabOS (pierwsza randomizacja) - 13. Śródmiąższowa choroba płuc z utrzymującymi się objawami przedmiotowymi i podmiotowymi w momencie wyrażenia świadomej zgody;","language":19,"languageDescription":"Polish"},{"id":11153258,"uuid":"3dd59740-da2e-499d-8bb0-a47dbdb6ca69","attributeTranslation":"Pour FOSTER-CabOS (première randomisation) - 13. Maladie pulmonaire interstitielle avec signes et symptômes persistants au moment du consentement éclairé.","language":34,"languageDescription":"French (France)"},{"id":11153257,"uuid":"3dd59740-da2e-499d-8bb0-a47dbdb6ca69","attributeTranslation":"Per FOSTER-CabOS (prima randomizzazione) - 13. Malattia polmonare interstiziale con segni e sintomi in corso al momento del consenso informato.","language":14,"languageDescription":"Italian"},{"id":11153255,"uuid":"3dd59740-da2e-499d-8bb0-a47dbdb6ca69","attributeTranslation":"Voor FOSTER-CabOS,(eerste randomisatie) - 13. Interstitiële longziekte met aanhoudende tekenen en symptomen op het moment van geïnformeerde toestemming;","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11153254,"uuid":"3dd59740-da2e-499d-8bb0-a47dbdb6ca69","attributeTranslation":"Para FOSTER-CabOS (primera aleatorización) - 13. Enfermedad pulmonar intersticial con signos y síntomas continuos en el momento del consentimiento informado.","language":7,"languageDescription":"Spanish"}]},{"id":1544890,"number":7,"principalExclusionCriteria":"For FOSTER-CabOS (first randomization) - 14. Non-healing wound, non-healing ulcer, or non-healing bone fracture","principalExclusionCriteriaTranslations":[{"id":11153260,"uuid":"6c4a9be8-b8d2-4cc3-9679-9fc327ebe1ef","attributeTranslation":"Voor FOSTER-CabOS,(eerste randomisatie) - 14. Niet-genezende wond, niet-genezende zweer of niet-genezende botbreuk;","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11153262,"uuid":"6c4a9be8-b8d2-4cc3-9679-9fc327ebe1ef","attributeTranslation":"Para FOSTER-CabOS (primera aleatorización) - 14. Herida que no cicatriza, úlcera que no cicatriza o fractura ósea que no cicatriza.","language":7,"languageDescription":"Spanish"},{"id":11153259,"uuid":"6c4a9be8-b8d2-4cc3-9679-9fc327ebe1ef","attributeTranslation":"W ramach FOSTER-CabOS (pierwsza randomizacja) - 14. Niegojąca się rana, niegojący się owrzodzenie lub niegojące się złamanie kości;","language":19,"languageDescription":"Polish"},{"id":11153263,"uuid":"6c4a9be8-b8d2-4cc3-9679-9fc327ebe1ef","attributeTranslation":"Per FOSTER-CabOS (prima randomizzazione) - 14. Ferita, ulcera o frattura ossea che non guariscono.","language":14,"languageDescription":"Italian"},{"id":11153261,"uuid":"6c4a9be8-b8d2-4cc3-9679-9fc327ebe1ef","attributeTranslation":"Pour FOSTER-CabOS (première randomisation) - 14. Plaie non cicatrisée, ulcère non cicatrisé ou fracture osseuse non consolidée.","language":34,"languageDescription":"French (France)"}]},{"id":1544891,"number":8,"principalExclusionCriteria":"For FOSTER-CabOS (first randomization) - 15. Patients with evidence or history of any bleeding diathesis, irrespective of severity;","principalExclusionCriteriaTranslations":[{"id":11153264,"uuid":"85c4887d-ebef-478e-b170-9fd24ec0da95","attributeTranslation":"W ramach FOSTER-CabOS (pierwsza randomizacja) - 15. Pacjenci z udokumentowaną lub w wywiadzie skazą krwotoczną, niezależnie od jej nasilenia;","language":19,"languageDescription":"Polish"},{"id":11153265,"uuid":"85c4887d-ebef-478e-b170-9fd24ec0da95","attributeTranslation":"Per FOSTER-CabOS (prima randomizzazione) - 15. Pazienti con evidenza o storia di qualsiasi diatesi emorragica, indipendentemente dalla gravità.","language":14,"languageDescription":"Italian"},{"id":11153267,"uuid":"85c4887d-ebef-478e-b170-9fd24ec0da95","attributeTranslation":"Para FOSTER-CabOS (primera aleatorización) - 15. Pacientes con evidencia o antecedentes de cualquier diátesis hemorrágica, independientemente de su gravedad.","language":7,"languageDescription":"Spanish"},{"id":11153268,"uuid":"85c4887d-ebef-478e-b170-9fd24ec0da95","attributeTranslation":"Voor FOSTER-CabOS,(eerste randomisatie) - 15. Patiënten met bewijs of voorgeschiedenis van een bloedingsstoornis, ongeacht de ernst;","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11153266,"uuid":"85c4887d-ebef-478e-b170-9fd24ec0da95","attributeTranslation":"Pour FOSTER-CabOS (première randomisation) - 15. Patients présentant des signes ou des antécédents de diathèse hémorragique, quelle qu’en soit la sévérité.","language":34,"languageDescription":"French (France)"}]},{"id":1544892,"number":9,"principalExclusionCriteria":"For FOSTER-CabOS (first randomization) - 16. Any haemorrhage or bleeding event ≥ CTCAE v5 Grade 3 within 4 weeks prior to the first study drug administration;","principalExclusionCriteriaTranslations":[{"id":11153270,"uuid":"bf943e9c-f01d-4df3-abe1-b3a4f80c360b","attributeTranslation":"Para FOSTER-CabOS (primera aleatorización) - 16. Cualquier hemorragia o episodio hemorrágico ≥ CTCAE v5 Grado 3 en las 4 semanas previas a la primera administración del fármaco del estudio.","language":7,"languageDescription":"Spanish"},{"id":11153272,"uuid":"bf943e9c-f01d-4df3-abe1-b3a4f80c360b","attributeTranslation":"Pour FOSTER-CabOS (première randomisation) - 16. Tout épisode hémorragique ou événement de saignement ≥ Grade 3 selon le CTCAE v5 dans les 4 semaines précédant la première administration du médicament de l’étude.","language":34,"languageDescription":"French (France)"},{"id":11153269,"uuid":"bf943e9c-f01d-4df3-abe1-b3a4f80c360b","attributeTranslation":"W ramach FOSTER-CabOS (pierwsza randomizacja) - 16. Jakiekolwiek krwawienie lub zdarzenie krwotoczne ≥ stopnia 3 wg CTCAE v5 w ciągu 4 tygodni przed pierwszym podaniem leku badanego;","language":19,"languageDescription":"Polish"},{"id":11153271,"uuid":"bf943e9c-f01d-4df3-abe1-b3a4f80c360b","attributeTranslation":"Voor FOSTER-CabOS,(eerste randomisatie) - 16. Een bloeding of voorval ≥ CTCAE v5 graad 3 binnen 4 weken voorafgaand aan de eerste toediening van het studiegeneesmiddel","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11153273,"uuid":"bf943e9c-f01d-4df3-abe1-b3a4f80c360b","attributeTranslation":"Per FOSTER-CabOS (prima randomizzazione) - 16. Qualsiasi emorragia o evento emorragico ≥ CTCAE v5 Grado 3 entro 4 settimane prima della prima somministrazione del farmaco in studio.","language":14,"languageDescription":"Italian"}]}]},"endPoint":{"primaryEndPoints":[{"id":1056168,"number":1,"endPoint":"For FOSTER evolving study platform: EFS: time from diagnosis to the first occurrence of progression/relapse (local, regional, or distant), second primary malignancy, or death from any cause; events per investigator assessment with central review when available. Patients without an event are censored at the date of last follow-up. The 3-year EFS rate will be estimated using Kaplan–Meier methods.","isPrimary":true,"endPointTranslations":[{"id":11153017,"uuid":"e56e1b7f-12d9-4d5c-91a7-f244a9c607e7","attributeTranslation":"De l’étude évolutive plateforme FOSTER : SSE : délai entre le diagnostic et la première occurrence d'une progression/récidive (locale, régionale ou à distance), d'une deuxième tumeur maligne, ou d'un décès, quelle qu'en soit la cause ; événements évalués par l'investigateur et soumis à une relecture centralisée lorsque cela est possible. Les patients n'ayant présenté aucun événement sont censurés à la date du dernier suivi. Le taux de SSE à 3 ans sera estimé à l'aide des méthodes de Kaplan-Meier","language":34,"languageDescription":"French (France)"},{"id":11153018,"uuid":"e56e1b7f-12d9-4d5c-91a7-f244a9c607e7","attributeTranslation":"Para la plataforma del estudio FOSTER-evolving: Supervivencia Libre de Eventos (SLE): tiempo transcurrido desde la biopsia hasta la primera recidiva o progresión (local, regional o a distancia), segunda malignidad primaria, o muerte por caulquier causa; eventos por cada evaluación del investigador con revisión central cuando esté disponible. Los pacientes sin evento son censurados en la fecha del último seguimiento. El ratio SLE a 3 años será estimado mediante métodos de Kaplan-Meier.","language":7,"languageDescription":"Spanish"},{"id":11153014,"uuid":"e56e1b7f-12d9-4d5c-91a7-f244a9c607e7","attributeTranslation":"Voor het FOSTER onderzoeksplatform: Veranderingsvrije overleving : tijd tussen de diagnose en het eerste optreden van verergering/terugval (lokaal, regionaal of op afstand), tweede primaire maligniteit of overlijden door welke oorzaak dan ook; gebeurtenissen per beoordeling door onderzoeker met centrale beoordeling indien beschikbaar. Patiënten zonder een verandering worden gecensureerd op de datum van de laatste follow-up. Het 3-jaars EFS-percentage wordt geschat met behulp van Kaplan-Meier-met","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11153016,"uuid":"e56e1b7f-12d9-4d5c-91a7-f244a9c607e7","attributeTranslation":"W ramach platformy badawczej FOSTER-Evolving: EFS: czas od rozpoznania do pierwszego wystąpienia progresji/nawrotu (miejscowego, regionalnego lub odległego), drugiego nowotworu złośliwego lub zgonu z jakiejkolwiek przyczyny; zdarzenia według oceny badacza z centralną weryfikacją, jeśli jest dostępna. Pacjenci bez zdarzeń są cenzurowani w dniu ostatniej kontroli. 3-letni wskaźnik EFS zostanie oszacowany przy użyciu metod Kaplana-Meiera.","language":19,"languageDescription":"Polish"},{"id":11153015,"uuid":"e56e1b7f-12d9-4d5c-91a7-f244a9c607e7","attributeTranslation":"Per lo studio evolutivo della piattaforma FOSTER : EFS: tempo dalla diagnosi alla prima comparsa di progressione/recidiva (locale, regionale o a distanza), seconda neoplasia primaria o decesso per qualsiasi causa; eventi secondo la valutazione dello sperimentatore con revisione centrale, ove disponibile. I pazienti senza eventi vengono censurati alla data dell'ultimo follow-up. Il tasso di EFS a 3 anni sarà stimato utilizzando il metodo Kaplan-Meier.","language":14,"languageDescription":"Italian"}]},{"id":1056169,"number":2,"endPoint":"For FOSTER-CabOS (first randomization) : Event-free survival (EFS): time from randomisation to first recurrence or progression (local, regional or distant) based on central review evaluation, or death from any cause. A patient without an event is considered censored at his or her last follow-up date.","isPrimary":true,"endPointTranslations":[{"id":11153021,"uuid":"2ecd0cdf-eac9-4327-8a02-3112245381e3","attributeTranslation":"Voor FOSTER-CabOS,(eerste randomisatie) : Veranderingsvrije overleving (EFS): tijd vanaf de randomisatie tot de eerste terugkeer of verergering (lokaal, regionaal of op afstand) van de tumor, op basis van centrale evaluatie, of overlijden door welke oorzaak dan ook. Een patiënt zonder verandering wordt als gecensureerd beschouwd op zijn of haar laatste follow-updatum.","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11153022,"uuid":"2ecd0cdf-eac9-4327-8a02-3112245381e3","attributeTranslation":"Para FOSTER-CabOS (primera aleatorización) : Supervivencia libre de eventos (EFS): tiempo transcurrido desde la aleatorización hasta la primera recurrencia o progresión (local, regional o a distancia) según la evaluación de la revisión central, o muerte por cualquier causa. Un paciente sin eventos se considera censurado en su última fecha de seguimiento.","language":7,"languageDescription":"Spanish"},{"id":11153023,"uuid":"2ecd0cdf-eac9-4327-8a02-3112245381e3","attributeTranslation":"Pour FOSTER-CabOS (première randomisation) : La Survie sans évènement (SSE) : temps écoulé entre la biopsie et la première récidive ou progression (locale, régionale ou à distance) basée sur une relecture centralisée, ou le décès quelque soit la cause.Un patient sans évènement est considéré censuré à sa dernière date de suivi.","language":34,"languageDescription":"French (France)"},{"id":11153019,"uuid":"2ecd0cdf-eac9-4327-8a02-3112245381e3","attributeTranslation":"W ramach FOSTER-CabOS (pierwsza randomizacja) : Przeżycie wolne od zdarzeń (EFS): czas od randomizacji do pierwszego nawrotu lub progresji choroby (miejscowej, lokalnej lub odległej) na podstawie oceny centralnej lub zgonu z jakiejkolwiek. Pacjenci bez zdarzeń są cenzurowani w dniu ostatniej kontroli.","language":19,"languageDescription":"Polish"},{"id":11153020,"uuid":"2ecd0cdf-eac9-4327-8a02-3112245381e3","attributeTranslation":"Per FOSTER-CabOS (prima randomizzazione) : EFS: tempo dalla randomizzazione alla prima recidiva o progressione (locale, regionale o a distanza) in base alla valutazione della revisione centrale o decesso per qualsiasi causa. Un paziente senza eventi è considerato censurato alla data dell'ultimo follow-up.","language":14,"languageDescription":"Italian"}]}],"secondaryEndPoints":[{"id":1056170,"number":1,"endPoint":"For FOSTER evolving study platform : Feasibility and compliance: screening-to-enrolment rate, consent rate, time to enrolment/treatment start, CRF data completeness (baseline/induction), first line chemotherapy treatment delivery (dose intensity, delays, reductions, early discontinuation, reasons), adherence to scheduled follow-up visits.","isPrimary":false,"endPointTranslations":[{"id":11153025,"uuid":"836a835e-773a-40aa-95df-d85901364000","attributeTranslation":"Per lo studio evolutivo della piattaforma FOSTER : Fattibilità e aderenza: tasso di screening rispetto all'arruolamento, tasso di consenso, tempo di arruolamento/inizio del trattamento, completezza dei dati CRF (baseline/induzione), somministrazione del trattamento chemioterapico di prima linea (intensità della dose, ritardi, riduzioni, interruzione precoce, motivi), aderenza alle visite di follow-up programmate.","language":14,"languageDescription":"Italian"},{"id":11153028,"uuid":"836a835e-773a-40aa-95df-d85901364000","attributeTranslation":"Para la plataforma del estudio FOSTER-evolving: Viabilidad y adherencia: ratio de screening y reclutamiento, ratio de consentimiento, tiempo hasta el reclutamiento e inicio de tratamiento, registro de datos en CRF (baseline/inducción), administración del tratamiento quimioterápico de primera linea (dosis, retrasos, reducciones, interrupción temprana, razones), adherencia para programar visitas de seguimiento.","language":7,"languageDescription":"Spanish"},{"id":11153024,"uuid":"836a835e-773a-40aa-95df-d85901364000","attributeTranslation":"Voor het FOSTER onderzoeksplatform : Haalbaarheid en naleving: percentage screening-tot-inschrijving, percentage toestemming, tijd tot inschrijving/start behandeling, volledigheid CRF-gegevens (baseline/inductie), toediening eerstelijns chemotherapie (doseringsintensiteit, vertragingen, verminderingen, vroegtijdige stopzetting, redenen), naleving van geplande follow-upbezoeken.","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11153026,"uuid":"836a835e-773a-40aa-95df-d85901364000","attributeTranslation":"De l’étude évolutive plateforme FOSTER : Faisabilité et observance : taux de patients screenés et enregistrés, taux de consentement donné, délai avant l'enregistrement/le début du traitement, remplissages des données du CRF (baseline/1ère ligne), administration du traitement de chimiothérapie de 1ère ligne (intensité de la dose, retards, réductions, arrêt prématuré, raisons), respect des visites de suivi prévues.","language":34,"languageDescription":"French (France)"},{"id":11153027,"uuid":"836a835e-773a-40aa-95df-d85901364000","attributeTranslation":"W ramach platformy badawczej FOSTER-Evolving : Wykonalność i zgodność: wskaźnik screening do włączenia do badania, wskaźnik uzyskanych świadomych zgód, czas włączenia do badania/rozpoczęcie leczenia, kompletność danych CRF (wyjściowych/indukcyjnych), podanie chemioterapii pierwszego rzutu (intensywność dawki, opóźnienia, zmniejszenie dawki, wcześniejsze przerwanie, przyczyny), przestrzeganie harmonogramu wizyt kontrolnych.","language":19,"languageDescription":"Polish"}]},{"id":1056171,"number":2,"endPoint":"For FOSTER evolving study platform : Disease-free patient: A patient who remains disease-free and alive at the completion of the first line conventional chemotherapy, as determined by clinical and radiological assessments conducted between 6 and 10 months after the start of treatment.","isPrimary":false,"endPointTranslations":[{"id":11153031,"uuid":"f934a5c8-733d-46da-a152-a090e882ecce","attributeTranslation":"De l’étude évolutive plateforme FOSTER : Patient sans maladie : Un patient qui reste sans maladie et en vie à la fin de la chimiothérapie standard de 1ère ligne, tel que déterminé par des évaluations cliniques et radiologiques effectuées entre 6 et 10 mois après le début du traitement","language":34,"languageDescription":"French (France)"},{"id":11153033,"uuid":"f934a5c8-733d-46da-a152-a090e882ecce","attributeTranslation":"Voor het FOSTER onderzoeksplatform : Ziektevrije patiënt: Een patiënt die na voltooiing van de eerstelijns conventionele chemotherapie ziektevrij en in leven blijft, zoals vastgesteld door klinische en radiologische beoordelingen die tussen 6 en 10 maanden na aanvang van de behandeling worden uitgevoerd.","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11153032,"uuid":"f934a5c8-733d-46da-a152-a090e882ecce","attributeTranslation":"W ramach platformy badawczej FOSTER-Evolving : Pacjent wolny od choroby: Pacjent, który pozostaje wolny od choroby i żyje po zakończeniu konwencjonalnej chemioterapii pierwszego rzutu, zgodnie z oceną kliniczną i radiologiczną przeprowadzoną między 6 a 10 miesiącem od rozpoczęcia leczenia.","language":19,"languageDescription":"Polish"},{"id":11153029,"uuid":"f934a5c8-733d-46da-a152-a090e882ecce","attributeTranslation":"Para la plataforma del estudio FOSTER-evolving: Paciente libre de enfermedad: Un paciente que permanece libre de enfermedad y vivo tras haber completado el tratamiento quimioterápico de primera linea, como está determinado mediante evaluaciones clínicas y radiológicas llevadas a cabo entre 6 y 10 meses después del inicio del tratamiento.","language":7,"languageDescription":"Spanish"},{"id":11153030,"uuid":"f934a5c8-733d-46da-a152-a090e882ecce","attributeTranslation":"Per lo studio evolutivo della piattaforma FOSTER : Paziente libero da malattia: paziente che rimane libero da malattia e vivo al completamento della chemioterapia convenzionale di prima linea, come determinato da valutazioni cliniche e radiologiche condotte tra 6 e 10 mesi dopo l'inizio del trattamento.","language":14,"languageDescription":"Italian"}]},{"id":1056172,"number":3,"endPoint":"For FOSTER evolving study platform : Overall survival (OS): time from diagnosis to death from any cause","isPrimary":false,"endPointTranslations":[{"id":11153038,"uuid":"ab6ee1fb-8116-4408-a821-3466b35fa346","attributeTranslation":"Para la plataforma del estudio FOSTER-evolving: Supervivencia global (SG): tiempo desde el diagnóstico hasta la muerte por cualquier causa.","language":7,"languageDescription":"Spanish"},{"id":11153036,"uuid":"ab6ee1fb-8116-4408-a821-3466b35fa346","attributeTranslation":"W ramach platformy badawczej FOSTER-Evolving : Całkowity czas przeżycia (OS): czas od diagnozy do śmierci z jakiejkolwiek przyczyny.","language":19,"languageDescription":"Polish"},{"id":11153037,"uuid":"ab6ee1fb-8116-4408-a821-3466b35fa346","attributeTranslation":"De l’étude évolutive plateforme FOSTER : Survie Globale (SG) délai entre le diagnostic et le décès, quelle qu'en soit la cause","language":34,"languageDescription":"French (France)"},{"id":11153035,"uuid":"ab6ee1fb-8116-4408-a821-3466b35fa346","attributeTranslation":"Voor het FOSTER onderzoeksplatform : Algehele overleving (OS): de tijd van diagnose tot overlijden door welke oorzaak dan ook","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11153034,"uuid":"ab6ee1fb-8116-4408-a821-3466b35fa346","attributeTranslation":"Per lo studio evolutivo della piattaforma FOSTER : Sopravvivenza globale (OS): tempo dalla diagnosi alla morte per qualsiasi causa","language":14,"languageDescription":"Italian"}]},{"id":1056173,"number":4,"endPoint":"For FOSTER evolving study platform : EFS: time from diagnosis to the first occurrence of progression/relapse (local, regional, or distant), second primary malignancy, or death from any cause; events per investigator assessment with central review when available. Patients without an event are censored at the date of last follow-up.","isPrimary":false,"endPointTranslations":[{"id":11153043,"uuid":"0db10526-0128-4248-bfb5-31e6e17a6140","attributeTranslation":"Per lo studio evolutivo della piattaforma FOSTER : EFS: tempo dalla diagnosi alla prima comparsa di progressione/recidiva (locale, regionale o a distanza), seconda neoplasia primaria o decesso per qualsiasi causa; eventi secondo la valutazione dell'investigatore con revisione centrale quando disponibile. Pazienti senza alcun evento vengono censurato alla data dell'ultimo follow-up.","language":14,"languageDescription":"Italian"},{"id":11153041,"uuid":"0db10526-0128-4248-bfb5-31e6e17a6140","attributeTranslation":"Voor het FOSTER onderzoeksplatform : Veranderingsvrije overleving (EFS): tijd tussen de diagnose en het eerste optreden van verergering/terugval (lokaal, regionaal of op afstand), tweede primaire maligniteit of overlijden door welke oorzaak dan ook; gebeurtenissen per beoordeling door onderzoeker met centrale beoordeling indien beschikbaar. Patiënten zonder een verandering worden gecensureerd op de datum van de laatste follow-up.","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11153040,"uuid":"0db10526-0128-4248-bfb5-31e6e17a6140","attributeTranslation":"W ramach platformy badawczej FOSTER-Evolving : EFS: czas od rozpoznania do pierwszego wystąpienia progresji/nawrotu (miejscowego, regionalnego lub odległego), drugiego nowotworu złośliwego lub zgonu z jakiejkolwiek przyczyny; zdarzenia według oceny badacza z centralną weryfikacją, jeśli jest dostępna. Pacjenci bez zdarzeń są cenzurowani w dniu ostatniej kontroli.","language":19,"languageDescription":"Polish"},{"id":11153039,"uuid":"0db10526-0128-4248-bfb5-31e6e17a6140","attributeTranslation":"De l’étude évolutive plateforme FOSTER : Survie sans événement (SSE) : délai entre la randomisation et la première récidive ou progression (locale, régionale ou à distance) sur la base d'une évaluation centrale, ou décès, quelle qu'en soit la cause. Un patient sans événement est considéré comme censuré à la date de son dernier suivi.","language":34,"languageDescription":"French (France)"},{"id":11153042,"uuid":"0db10526-0128-4248-bfb5-31e6e17a6140","attributeTranslation":"Para la plataforma del estudio FOSTER-evolving: EFS: tiempo transcurrido desde el diagnóstico hasta la primera aparición de progresión/recaída (local, regional o a distancia), segunda neoplasia maligna primaria o muerte por cualquier causa; eventos según la evaluación del investigador con revisión centralizada cuando esté disponible. Los pacientes sin eventos se censuran en la fecha del último seguimiento.","language":7,"languageDescription":"Spanish"}]},{"id":1056174,"number":5,"endPoint":"For FOSTER evolving study platform : Adverse events: incidence of treatment-emergent adverse events (AEs), serious adverse events (SAEs), and treatment-related mortality during induction.","isPrimary":false,"endPointTranslations":[{"id":11153046,"uuid":"783d5654-3518-40ba-9ab8-5559699d308d","attributeTranslation":"Para la plataforma del estudio FOSTER-evolving: Eventos adversos: incidencia de eventos adversos emergentes del tratamiento (AEs), eventos adversos serios (SAEs) y mortalidad relacionada con el tratamiento durante la inducción.","language":7,"languageDescription":"Spanish"},{"id":11153044,"uuid":"783d5654-3518-40ba-9ab8-5559699d308d","attributeTranslation":"Voor het FOSTER onderzoeksplatform : Ongewenste voorvallen: incidentie van tijdens de behandeling optredende bijwerkingen (AE's), ernstige bijwerkingen (SAE's) en behandelingsgerelateerde mortaliteit tijdens de inductiefase.","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11153047,"uuid":"783d5654-3518-40ba-9ab8-5559699d308d","attributeTranslation":"W ramach platformy badawczej FOSTER-Evolving : Zdarzenia niepożądane: częstość występowania zdarzeń niepożądanych związanych z leczeniem (AE), poważnych zdarzeń niepożądanych (SAE) oraz śmiertelności związanej z leczeniem podczas indukcji.","language":19,"languageDescription":"Polish"},{"id":11153048,"uuid":"783d5654-3518-40ba-9ab8-5559699d308d","attributeTranslation":"De l’étude évolutive plateforme FOSTER : Événements indésirables : incidence des événements indésirables (EI) émergents sous traitement (EIST) , des événements indésirables graves (EIG) et de la mortalité liée au traitement pendant la 1ère ligne de traitement.","language":34,"languageDescription":"French (France)"},{"id":11153045,"uuid":"783d5654-3518-40ba-9ab8-5559699d308d","attributeTranslation":"Per lo studio evolutivo della piattaforma FOSTER : Eventi avversi (AE): incidenza di AE emergenti dal trattamento, eventi avversi gravi (SAE) e mortalità correlata al trattamento durante l'induzione.","language":14,"languageDescription":"Italian"}]},{"id":1056175,"number":6,"endPoint":"For FOSTER evolving study platform : Quality of life and functional outcome: QoL assessed by EORTC QLQ-C30 and PedsQL; functional outcome assessed by TESS at predefined timepoints.","isPrimary":false,"endPointTranslations":[{"id":11153051,"uuid":"71bb682a-5345-4726-9473-e1ffe5525301","attributeTranslation":"De l’étude évolutive plateforme FOSTER : Qualité de vie et résultats fonctionnels : qualité de vie évaluée par EORTC QLQ-C30 et PedsQL ; résultats fonctionnels évalués par TESS à des moments prédéfinis.","language":34,"languageDescription":"French (France)"},{"id":11153052,"uuid":"71bb682a-5345-4726-9473-e1ffe5525301","attributeTranslation":"W ramach platformy badawczej FOSTER-Evolving : Jakość życia i wyniki funkcjonalne: jakość życia oceniana za pomocą EORTC QLQ-C30 i PedsQL; wyniki funkcjonalne oceniane za pomocą TESS w określonych wcześniej punktach czasowych.","language":19,"languageDescription":"Polish"},{"id":11153050,"uuid":"71bb682a-5345-4726-9473-e1ffe5525301","attributeTranslation":"Voor het FOSTER onderzoeksplatform : Kwaliteit van Leven en functionele uitkomst: KvL beoordeeld met EORTC QLQ-C30 en PedsQL; functionele uitkomst beoordeeld met TESS op vooraf vastgestelde momenten","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11153049,"uuid":"71bb682a-5345-4726-9473-e1ffe5525301","attributeTranslation":"Per lo studio evolutivo della piattaforma FOSTER : Qualità della vita e outcome funzionale: QoL valutata tramite EORTC QLQ-C30 e PedsQL; esito funzionale valutato tramite TESS a intervalli temporali predefiniti.","language":14,"languageDescription":"Italian"},{"id":11153053,"uuid":"71bb682a-5345-4726-9473-e1ffe5525301","attributeTranslation":"Para la plataforma del estudio FOSTER-evolving: Calidad de vida y resultado funcional: QoL evaluado mediante EORTC QLQ-C30 y PedsQL; resultado funcional evaluado mediante TESS en puntos temporales predefinidos.","language":7,"languageDescription":"Spanish"}]},{"id":1056176,"number":7,"endPoint":"For FOSTER evolving study platform : Prognostic factors: association of clinical and biological variables (including G1/G2 signature at diagnosis) with OS and EFS via multivariable-adjusted Cox models. Results reported as hazard ratios (HRs) with 95% confidence intervals (CIs) (pre-specified covariates and handling of missing data per SAP).","isPrimary":false,"endPointTranslations":[{"id":11153057,"uuid":"d8dc3ec4-8bff-4c79-a47f-0f0abb40241f","attributeTranslation":"W ramach platformy badawczej FOSTER-Evolving : Czynniki prognostyczne: związek zmiennych klinicznych i biologicznych (w tym sygnatury G1/G2 w momencie rozpoznania) z OS i EFS za pomocą modeli Coxa z wielowymiarową korektą. Wyniki przedstawiono jako współczynniki ryzyka (HR) z 95% przedziałami ufności (CI) (wcześniej określone zmienne towarzyszące i postępowanie z brakującymi danymi zgodnie z SAP).","language":19,"languageDescription":"Polish"},{"id":11153058,"uuid":"d8dc3ec4-8bff-4c79-a47f-0f0abb40241f","attributeTranslation":"Per lo studio evolutivo della piattaforma FOSTER : Fattori prognostici: associazione di variabili cliniche e biologiche (inclusa la signature G1/G2 alla diagnosi) con OS ed EFS tramite modelli di Cox aggiustati per variabili multiple. Risultati riportati come hazard ratio (HR) con intervalli di confidenza (IC) al 95% (covariate predefinite e gestione dei dati mancanti secondo SAP).","language":14,"languageDescription":"Italian"},{"id":11153056,"uuid":"d8dc3ec4-8bff-4c79-a47f-0f0abb40241f","attributeTranslation":"Voor het FOSTER onderzoeksplatform : Voorspellende factoren: verband tussen klinische en biologische variabelen (waaronder G1/G2-signatuur bij diagnose) en OS en EFS via multivariabele gecorrigeerde Cox-modellen. Resultaten gerapporteerd als hazard ratio's (HR's) met 95% betrouwbaarheidsintervallen (BI's) (vooraf gespecificeerde covariaten en verwerking van ontbrekende gegevens volgens SAP).","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11153055,"uuid":"d8dc3ec4-8bff-4c79-a47f-0f0abb40241f","attributeTranslation":"De l’étude évolutive plateforme FOSTER : Facteurs pronostiques : association des variables cliniques et biologiques (y compris la signature G1/G2 au moment du diagnostic) avec la SG et la SSE via des modèles de Cox ajustés sur plusieurs variables. Résultats rapportés sous forme de rapports de risque (RR) avec des intervalles de confiance (IC) à 95 % (covariables prédéfinies et traitement des données manquantes selon le SAP).","language":34,"languageDescription":"French (France)"},{"id":11153054,"uuid":"d8dc3ec4-8bff-4c79-a47f-0f0abb40241f","attributeTranslation":"Para la plataforma del estudio FOSTER-evolving: Factores de pronóstico: asociación de variables clínicas y biológicas (incluyendo la firma G1/G2 en el diagnóstico) con SG y SLE mediante modelos Cox ajustados a multivariable. Resultados reportados como tasas de riesgo (HRs) con un intervalo de confianza (IC) del 95% (covariables preespecificadas y manejo de datos faltantes por SAP).","language":7,"languageDescription":"Spanish"}]},{"id":1056177,"number":8,"endPoint":"For FOSTER-CabOS (first randomization) : Adverse events (AE), a real-time reporting of any AE of grade 3+ is planned during the first 8 weeks in the first 20 patients receiving mifamurtide.","isPrimary":false,"endPointTranslations":[{"id":11153063,"uuid":"0abae5c9-6868-4b68-bae5-a8f7dc7470c5","attributeTranslation":"W ramach FOSTER-CabOS (pierwsza randomizacja) :Zdarzenia niepożądane (AE): planowane jest raportowanie w czasie rzeczywistym wszystkich zdarzeń niepożądanych w stopniu +3 w ciągu pierwszych 8 tygodni u pierwszych 40 pacjentów otrzymujących mifamurtyd.","language":19,"languageDescription":"Polish"},{"id":11153059,"uuid":"0abae5c9-6868-4b68-bae5-a8f7dc7470c5","attributeTranslation":"Voor FOSTER-CabOS,(eerste randomisatie) : Ongewenste voorvallen (AE), een real-time rapportage van elke AE van graad 3+ is gepland gedurende de eerste 8 weken bij de eerste 40 patiënten die mifamurtide krijgen.","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11153061,"uuid":"0abae5c9-6868-4b68-bae5-a8f7dc7470c5","attributeTranslation":"Pour FOSTER-CabOS (première randomisation) : Evénements indésirables (EI): un rapport en temps réel de tout EI de grade 3+ (selon le NCI-CTCAE v5.0) est prévu au cours des 8 premières semaines chez les 40 premiers patients recevant le mifamurtide.","language":34,"languageDescription":"French (France)"},{"id":11153060,"uuid":"0abae5c9-6868-4b68-bae5-a8f7dc7470c5","attributeTranslation":"Per FOSTER-CabOS (prima randomizzazione) : AE: è prevista una segnalazione in tempo reale di qualsiasi AE di grado 3+ durante le prime 8 settimane nei primi 40 pazienti trattati con mifamurtide.","language":14,"languageDescription":"Italian"},{"id":11153062,"uuid":"0abae5c9-6868-4b68-bae5-a8f7dc7470c5","attributeTranslation":"Para FOSTER-CabOS (primera aleatorización): Eventos adversos (EA): se prevé la notificación en tiempo real de cualquier EA de grado 3+ durante las primeras 8 semanas en los primeros 40 pacientes que reciban mifamurtida.","language":7,"languageDescription":"Spanish"}]},{"id":1056178,"number":9,"endPoint":"For FOSTER-CabOS (first randomization) : Quality-adjusted time without symptoms of disease or toxicity (Quality-adjusted Time Without Symptoms of disease recurrence or Toxicity (Q-TWiST)) computed from survival times (OS and Event Free Survival (EFS) duration) and adverse events data (duration of time spent with a severe-AE before progression/recurrence)","isPrimary":false,"endPointTranslations":[{"id":11153067,"uuid":"8dfe08ca-8e2c-41fe-abc9-69fd9d3b8c15","attributeTranslation":"Para FOSTER-CabOS (primera aleatorización) : Tiempo ajustado por calidad sin síntomas de enfermedad o toxicidad (tiempo ajustado por calidad sin síntomas de recurrencia de la enfermedad o toxicidad [Q-TWiST]), calculado a partir de los tiempos de supervivencia (supervivencia global [SG] y supervivencia libre de eventos [SLE]) y los datos de eventos adversos (duración del tiempo transcurrido con un EA grave antes de la progresión/recurrencia).","language":7,"languageDescription":"Spanish"},{"id":11153064,"uuid":"8dfe08ca-8e2c-41fe-abc9-69fd9d3b8c15","attributeTranslation":"Per FOSTER-CabOS (prima randomizzazione) : Tempo senza sintomi di malattia o tossicità aggiustato per la qualità (tempo senza sintomi di recidiva di malattia o tossicità aggiustato per la qualità (Q-TWiST)) calcolato dai tempi di sopravvivenza (durata della OS e EFS) e dai dati sugli AE (durata del tempo trascorso con un AE grave prima della progressione/recidiva).","language":14,"languageDescription":"Italian"},{"id":11153066,"uuid":"8dfe08ca-8e2c-41fe-abc9-69fd9d3b8c15","attributeTranslation":"W ramach FOSTER-CabOS (pierwsza randomizacja) : Q-TWiST: czas przeżycia skorygowany o jakość życia, wolny od objawów nawrotu choroby i toksyczności leczenia, obliczany na podstawie danych dotyczących przeżycia (OS i EFS) oraz zdarzeń niepożądanych (czas trwania ciężkich AE przed progresją/nawrotem).","language":19,"languageDescription":"Polish"},{"id":11153068,"uuid":"8dfe08ca-8e2c-41fe-abc9-69fd9d3b8c15","attributeTranslation":"Pour FOSTER-CabOS (première randomisation) : Temps sans symptômes de maladie ou de toxicité ajusté à la qualité (Q-TWiST) calculé à partir des temps de survie (SG et durée de survie sans évènement (SSE)) et des données sur les événements indésirables (durée passée avec un EI sévère avant progression/rechute).","language":34,"languageDescription":"French (France)"},{"id":11153065,"uuid":"8dfe08ca-8e2c-41fe-abc9-69fd9d3b8c15","attributeTranslation":"Voor FOSTER-CabOS,(eerste randomisatie) : Voor kwaliteit gecorrigeerde tijd zonder symptomen van ziekte of toxiciteit (Quality-adjusted Time Without Symptoms of disease recurrence or Toxicity (Q-TWiST)) berekend op basis van overlevingstijden (OS en veranderingsvrije overleving (EFS) duur) en gegevens over ongewenste voorvallen (duur van de tijd doorgebracht met een ernstige-AE vóór verergering/terugkeer).","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":1056179,"number":10,"endPoint":"For FOSTER-CabOS (first randomization) : Disease status based on initial staging and complete remission after first line treatment histological response; biological subgroups in particular G1/G2 diagnostic RNAseq signature; type of first line chemotherapy; use of mifamurtide ; age, metastatic status at diagnosis.","isPrimary":false,"endPointTranslations":[{"id":11153071,"uuid":"a39c266f-9eb4-4912-8cc1-9fa9c5fa2e71","attributeTranslation":"Pour FOSTER-CabOS (première randomisation) : Statut de la maladie basé sur la stadification initiale et la rémission complète apprès la première ligne de traitement et la réponse histologique ; sous-groupes biologiques, en particulier signature ARNseq diagnostique G1/G2 ; type de chimiothérapie de première ligne ; utilisation du mifamurtide ; âge, le statut métastatique au diagnostic.","language":34,"languageDescription":"French (France)"},{"id":11153072,"uuid":"a39c266f-9eb4-4912-8cc1-9fa9c5fa2e71","attributeTranslation":"W ramach FOSTER-CabOS (pierwsza randomizacja) : stan choroby na podstawie początkowej klasyfikacji stopnia zaawansowania w stanie całkowitej remisji po leczeniu pierwszego rzutu; podgrupy biologiczne, w szczególności sygnatura diagnostyczna RNAseq G1/G2; rodzaj chemioterapii pierwszego rzutu; stosowanie mifamurtydu; wiek, obecność przerzutów w momencie rozpoznania.","language":19,"languageDescription":"Polish"},{"id":11153073,"uuid":"a39c266f-9eb4-4912-8cc1-9fa9c5fa2e71","attributeTranslation":"Per FOSTER-CabOS (prima randomizzazione) : Stato della malattia in base stadiazione iniziale e sulla risposta istologica al trattamento di prima linea; sottogruppi biologici in particolare firma diagnostica RNAseq G1/G2; tipo di chemioterapia di prima linea; uso di mifamurtide; età, stato metastatico alla diagnosi.","language":14,"languageDescription":"Italian"},{"id":11153069,"uuid":"a39c266f-9eb4-4912-8cc1-9fa9c5fa2e71","attributeTranslation":"Para FOSTER-CabOS (primera aleatorización) : estado de la enfermedad basados en la estadificación inicial y la respuesta histológica del tumor primario; subgrupos biológicos, en particular la firma diagnóstica G1/G2 de RNAseq; tipo de quimioterapia de primera línea; uso de mifamurtida : edad y estado metastásico en el momento del diagnóstico.","language":7,"languageDescription":"Spanish"},{"id":11153070,"uuid":"a39c266f-9eb4-4912-8cc1-9fa9c5fa2e71","attributeTranslation":"Voor FOSTER-CabOS,(eerste randomisatie) : ziektesstatus gebaseerd op initiële gradering en volledige remissie na eerstelijnsbehandeling ; biologische subgroepen met name G1/G2 diagnostische RNAseq signatuur; type eerstelijns chemotherapie; gebruik van mifamurtide: leeftijd, aanwezigheid van uitzaaiingen bij de diagnose","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":1056180,"number":11,"endPoint":"For FOSTER-CabOS (first randomization) : Heigh and growth plate","isPrimary":false,"endPointTranslations":[{"id":11153078,"uuid":"d94865d9-b8b5-4358-a4c6-9959344a3b9e","attributeTranslation":"W ramach FOSTER-CabOS (pierwsza randomizacja) :Ocena wzrostu i chrząstki wzrostowej.","language":19,"languageDescription":"Polish"},{"id":11153076,"uuid":"d94865d9-b8b5-4358-a4c6-9959344a3b9e","attributeTranslation":"Per FOSTER-CabOS (prima randomizzazione) : Altezza e cartilagine di accrescimento.","language":14,"languageDescription":"Italian"},{"id":11153075,"uuid":"d94865d9-b8b5-4358-a4c6-9959344a3b9e","attributeTranslation":"Pour FOSTER-CabOS (première randomisation) : Comparaison de la hauteur et vitesse de croissance des patients avec cabozantinib comparé aux patients avec les soins de support","language":34,"languageDescription":"French (France)"},{"id":11153074,"uuid":"d94865d9-b8b5-4358-a4c6-9959344a3b9e","attributeTranslation":"Voor FOSTER-CabOS,(eerste randomisatie) : Lengte en groeischijven","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11153077,"uuid":"d94865d9-b8b5-4358-a4c6-9959344a3b9e","attributeTranslation":"Para FOSTER-CabOS (primera aleatorización) : Estatura y placa de crecimiento.","language":7,"languageDescription":"Spanish"}]},{"id":1056181,"number":12,"endPoint":"For FOSTER-CabOS (first randomization) : Description of would healing complication","isPrimary":false,"endPointTranslations":[{"id":11153082,"uuid":"c4d5f24a-77ca-4861-9ebc-9f2d9a97dd77","attributeTranslation":"Pour FOSTER-CabOS (première randomisation) : Description des complications de la cicatrisation entre les patients sous cabozantinib et patients avec les soins de support","language":34,"languageDescription":"French (France)"},{"id":11153083,"uuid":"c4d5f24a-77ca-4861-9ebc-9f2d9a97dd77","attributeTranslation":"Voor FOSTER-CabOS,(eerste randomisatie) : Beschrijving van complicaties bij de wondgenezing","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11153080,"uuid":"c4d5f24a-77ca-4861-9ebc-9f2d9a97dd77","attributeTranslation":"Per FOSTER-CabOS (prima randomizzazione) : Descrizione di possibili complicanze nella guarigione delle ferite.","language":14,"languageDescription":"Italian"},{"id":11153079,"uuid":"c4d5f24a-77ca-4861-9ebc-9f2d9a97dd77","attributeTranslation":"W ramach FOSTER-CabOS (pierwsza randomizacja) : Opis powikłań związanych z gojeniem ran.","language":19,"languageDescription":"Polish"},{"id":11153081,"uuid":"c4d5f24a-77ca-4861-9ebc-9f2d9a97dd77","attributeTranslation":"Para FOSTER-CabOS (primera aleatorización) : Descripción de las complicaciones en la cicatrización de heridas.","language":7,"languageDescription":"Spanish"}]},{"id":1056182,"number":13,"endPoint":"For FOSTER evolving study platform : (if applicable) Comparisons between treatment sequences: comparisons of survival overall treatment sequences using Cox proportional hazards models (with multivariable adjustment) and Kaplan–Meier estimates with log-rank tests. The absence of randomization may also imply the use of weighting methods such as Inverse Probability of Censoring Weighting ( IPCW).","isPrimary":false,"endPointTranslations":[{"id":11153086,"uuid":"651a33ec-8445-4737-ab0e-7b46db87e1ea","attributeTranslation":"Voor het FOSTER onderzoeksplatform : (indien van toepassing) Vergelijkingen tussen behandelingsreeksen: vergelijkingen van de totale overleving tussen behandelingsreeksen met behulp van Cox proportionele hazardmodellen (met multivariabele aanpassing) en Kaplan-Meier-schattingen met log-rank-testen. Het ontbreken van randomisatie kan ook het gebruik van weegmethoden suggereren, zoals de Inverse Probability of Censoring Weighting (IPCW) suggereren.","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11153088,"uuid":"651a33ec-8445-4737-ab0e-7b46db87e1ea","attributeTranslation":"W ramach platformy badawczej FOSTER-Evolving : (jeśli dotyczy) Porównania między sekwencjami leczenia: porównania przeżywalności w różnych sekwencjach leczenia przy użyciu modeli proporcjonalnego ryzyka Coxa (z wieloczynnikową korektą) oraz oszacowań Kaplana-Meiera z testem log-rank; w przypadku braku randomizacji możliwe zastosowanie metod ważenia, takich jak IPCW (Inverse Probability of Censoring Weighting).","language":19,"languageDescription":"Polish"},{"id":11153085,"uuid":"651a33ec-8445-4737-ab0e-7b46db87e1ea","attributeTranslation":"Para la plataforma del estudio FOSTER-evolving: (si procede) Comparaciones entre secuencias de tratamiento: comparaciones de la supervivencia global entre secuencias de tratamiento utilizando modelos de riesgos proporcionales de Cox (con ajuste multivariable) y estimaciones de Kaplan-Meier con pruebas de log-rank. La ausencia de aleatorización también puede implicar el uso de métodos de ponderación, como la ponderación por probabilidad inversa de censura (IPCW).","language":7,"languageDescription":"Spanish"},{"id":11153084,"uuid":"651a33ec-8445-4737-ab0e-7b46db87e1ea","attributeTranslation":"Per lo studio evolutivo della piattaforma FOSTER : (se applicabile) Confronti tra sequenze di trattamento: confronti di sopravvivenza tra sequenze di trattamento utilizzando modelli di rischi proporzionali di Cox (con aggiustamento multivariato) e stime di Kaplan-Meier con test log-rank. L'assenza di randomizzazione può anche implicare l'uso di metodi di ponderazione come l'Inverse Probability of Censoring Weighting (IPCW).","language":14,"languageDescription":"Italian"},{"id":11153087,"uuid":"651a33ec-8445-4737-ab0e-7b46db87e1ea","attributeTranslation":"De l’étude évolutive plateforme FOSTER : (le cas échéant) Comparaisons entre les séquences de traitement : comparaisons de la survie en globalité des séquences de traitement à l'aide de modèles de risques proportionnels de Cox (avec ajustement multivarié) et d'estimations de Kaplan-Meier avec tests du log-rank. L'absence de randomisation peut également impliquer l'utilisation de méthodes de pondération telles que la pondération par la probabilité inverse de censure (IPCW).","language":34,"languageDescription":"French (France)"}]},{"id":1056183,"number":14,"endPoint":"For FOSTER evolving study platform : ctDNA analyses.","isPrimary":false,"endPointTranslations":[{"id":11153090,"uuid":"c9c1ac44-6383-47c5-9c1b-115196859d4d","attributeTranslation":"Voor het FOSTER onderzoeksplatform : ctDNA analysen","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11153089,"uuid":"c9c1ac44-6383-47c5-9c1b-115196859d4d","attributeTranslation":"Para la plataforma del estudio FOSTER-evolving: Analisis ctDNA","language":7,"languageDescription":"Spanish"},{"id":11153092,"uuid":"c9c1ac44-6383-47c5-9c1b-115196859d4d","attributeTranslation":"Per lo studio evolutivo della piattaforma FOSTER : Analisi del ctDNA.","language":11,"languageDescription":"Irish"},{"id":11153093,"uuid":"c9c1ac44-6383-47c5-9c1b-115196859d4d","attributeTranslation":"W ramach platformy badawczej FOSTER-Evolving : Analizy ctDNA.","language":19,"languageDescription":"Polish"},{"id":11153091,"uuid":"c9c1ac44-6383-47c5-9c1b-115196859d4d","attributeTranslation":"De l’étude évolutive plateforme FOSTER : Analyse ADN circulants","language":34,"languageDescription":"French (France)"}]},{"id":1056184,"number":15,"endPoint":"For FOSTER evolving study platform : Radiomics analyses.","isPrimary":false,"endPointTranslations":[{"id":11153094,"uuid":"a6b42207-3969-4223-89b0-33d720486770","attributeTranslation":"De l’étude évolutive plateforme FOSTER : Anlyses radiomics","language":34,"languageDescription":"French (France)"},{"id":11153095,"uuid":"a6b42207-3969-4223-89b0-33d720486770","attributeTranslation":"Per lo studio evolutivo della piattaforma FOSTER : Analisi radiomiche.","language":14,"languageDescription":"Italian"},{"id":11153096,"uuid":"a6b42207-3969-4223-89b0-33d720486770","attributeTranslation":"Para la plataforma del estudio FOSTER-evolving: Analisis radiómicos","language":7,"languageDescription":"Spanish"},{"id":11153098,"uuid":"a6b42207-3969-4223-89b0-33d720486770","attributeTranslation":"Voor het FOSTER onderzoeksplatform : radiomische analysen","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11153097,"uuid":"a6b42207-3969-4223-89b0-33d720486770","attributeTranslation":"W ramach platformy badawczej FOSTER-Evolving : Analizy radiomiczne.","language":19,"languageDescription":"Polish"}]},{"id":1056185,"number":16,"endPoint":"For FOSTER evolving study platform : Imaging-based definition of lung metastases (number, characteristics, location) derived by AI and compared with anatomic pathology.","isPrimary":false,"endPointTranslations":[{"id":11153100,"uuid":"8aa1075e-dde9-4031-a19f-6f7a60bab819","attributeTranslation":"Per lo studio evolutivo della piattaforma FOSTER : Definizione basata sull'imaging delle metastasi polmonari (numero, caratteristiche, posizione) derivata dall'intelligenza artificiale e confrontata con l'anatomia patologica.","language":14,"languageDescription":"Italian"},{"id":11153102,"uuid":"8aa1075e-dde9-4031-a19f-6f7a60bab819","attributeTranslation":"De l’étude évolutive plateforme FOSTER : Définition des métastases pulmonaires basée sur l'imagerie (nombre, caractéristiques, emplacement) dérivée de l'IA et comparée à l'anatomopathologie.","language":34,"languageDescription":"French (France)"},{"id":11153099,"uuid":"8aa1075e-dde9-4031-a19f-6f7a60bab819","attributeTranslation":"W ramach platformy badawczej FOSTER-Evolving : Definicja przerzutów do płuc oparta na obrazowaniu (liczba, charakterystyka, lokalizacja) opracowana przez sztuczną inteligencję i porównana z danymi anatomicznymi.","language":19,"languageDescription":"Polish"},{"id":11153101,"uuid":"8aa1075e-dde9-4031-a19f-6f7a60bab819","attributeTranslation":"Voor het FOSTER onderzoeksplatform : definitie van longmetastase (aantal, karakteristiek, lokalisatie) gebaseerd op beeldvorming verkregen door AI en vergeleken met anatomische pathologie","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11153103,"uuid":"8aa1075e-dde9-4031-a19f-6f7a60bab819","attributeTranslation":"Para la plataforma del estudio FOSTER-evolving: nueva definición por imagen de la metástasis pulmonar (número, características, localización) definida por IA en comparación con la vista anapatológica","language":7,"languageDescription":"Spanish"}]},{"id":1056186,"number":17,"endPoint":"For FOSTER evolving study platform : Incorporation of questionnaire results into clinical interpretation.","isPrimary":false,"endPointTranslations":[{"id":11153108,"uuid":"52c19198-7bdb-4ede-9848-fff0638a48e2","attributeTranslation":"W ramach platformy badawczej FOSTER-Evolving : Włączenie wyników ankiety do interpretacji klinicznej.","language":19,"languageDescription":"Polish"},{"id":11153106,"uuid":"52c19198-7bdb-4ede-9848-fff0638a48e2","attributeTranslation":"De l’étude évolutive plateforme FOSTER : Intégration des résultats des questionnaires dans l'interprétation clinique","language":34,"languageDescription":"French (France)"},{"id":11153107,"uuid":"52c19198-7bdb-4ede-9848-fff0638a48e2","attributeTranslation":"Per lo studio evolutivo della piattaforma FOSTER : Incorporazione dei risultati del questionario nell'interpretazione clinica.","language":14,"languageDescription":"Italian"},{"id":11153105,"uuid":"52c19198-7bdb-4ede-9848-fff0638a48e2","attributeTranslation":"Para la plataforma del estudio FOSTER-evolving: Tener en cuenta los resultados de los cuestionarios en la interpretación clínica","language":7,"languageDescription":"Spanish"},{"id":11153104,"uuid":"52c19198-7bdb-4ede-9848-fff0638a48e2","attributeTranslation":"Voor het FOSTER onderzoeksplatform : Opname van de resultaten van de vragenlijst in de klinische interpretatie.","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":1056187,"number":18,"endPoint":"For FOSTER evolving study platform : Number of countries participating in the FOSTER-Evolving study platform over time.","isPrimary":false,"endPointTranslations":[{"id":11153110,"uuid":"4fa68762-bf26-4af3-b3ea-4d3572062e32","attributeTranslation":"W ramach platformy badawczej FOSTER-Evolving : Liczba krajów uczestniczących w Platformie Badawczej FOSTER-Evolving.","language":19,"languageDescription":"Polish"},{"id":11153111,"uuid":"4fa68762-bf26-4af3-b3ea-4d3572062e32","attributeTranslation":"Per lo studio evolutivo della piattaforma FOSTER : Numero di paesi che hanno partecipato alla piattaforma di studio in evoluzione FOSTER nel tempo.","language":14,"languageDescription":"Italian"},{"id":11153113,"uuid":"4fa68762-bf26-4af3-b3ea-4d3572062e32","attributeTranslation":"Voor het FOSTER onderzoeksplatform : Het aantal landen dat over tijd deelneemt aan het FOSTER onderzoeksplatform.","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11153109,"uuid":"4fa68762-bf26-4af3-b3ea-4d3572062e32","attributeTranslation":"Para la plataforma del estudio FOSTER-evolving: Número de países participantes en la plataforma de estudios FOSTER-Evolving","language":7,"languageDescription":"Spanish"},{"id":11153112,"uuid":"4fa68762-bf26-4af3-b3ea-4d3572062e32","attributeTranslation":"De l’étude évolutive plateforme FOSTER : Nombre de pays participant à l'étude FOSTER plateforme Evolutive au fil du temps","language":34,"languageDescription":"French (France)"}]},{"id":1056188,"number":19,"endPoint":"For FOSTER evolving study platform : Number of samples collected per registered patient.","isPrimary":false,"endPointTranslations":[{"id":11153117,"uuid":"9a488ef7-7f06-41b2-8da2-e590b2c8d641","attributeTranslation":"De l’étude évolutive plateforme FOSTER : nombre d'échantillon prélevés par patient enregistré","language":34,"languageDescription":"French (France)"},{"id":11153114,"uuid":"9a488ef7-7f06-41b2-8da2-e590b2c8d641","attributeTranslation":"W ramach platformy badawczej FOSTER-Evolving : Liczba próbek pobranych od każdego włączonego pacjenta.","language":19,"languageDescription":"Polish"},{"id":11153115,"uuid":"9a488ef7-7f06-41b2-8da2-e590b2c8d641","attributeTranslation":"Per lo studio evolutivo della piattaforma FOSTER : Numero di campioni raccolti per paziente registrato.","language":14,"languageDescription":"Italian"},{"id":11153118,"uuid":"9a488ef7-7f06-41b2-8da2-e590b2c8d641","attributeTranslation":"Para la plataforma del estudio FOSTER-evolving: Número de muestras recogidas por cada paciente registrado","language":7,"languageDescription":"Spanish"},{"id":11153116,"uuid":"9a488ef7-7f06-41b2-8da2-e590b2c8d641","attributeTranslation":"Voor het FOSTER onderzoeksplatform : Het aantal materialen dat verzameld is per geregistreerde patiënt","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":1056189,"number":20,"endPoint":"For FOSTER evolving study platform : Number and type of analyses performed per registered patient.","isPrimary":false,"endPointTranslations":[{"id":11153120,"uuid":"f7dc8445-4a03-4459-9ca1-0e7cd8517a57","attributeTranslation":"W ramach platformy badawczej FOSTER-Evolving : Liczba i rodzaj analiz przeprowadzonych na włączonym pacjencie.","language":19,"languageDescription":"Polish"},{"id":11153119,"uuid":"f7dc8445-4a03-4459-9ca1-0e7cd8517a57","attributeTranslation":"Per lo studio evolutivo della piattaforma FOSTER : Numero e tipo di analisi eseguite per paziente registrato.","language":14,"languageDescription":"Italian"},{"id":11153122,"uuid":"f7dc8445-4a03-4459-9ca1-0e7cd8517a57","attributeTranslation":"Para la plataforma del estudio FOSTER-evolving: Número y tipo de analisis realizado por cada paciente registrado","language":7,"languageDescription":"Spanish"},{"id":11153121,"uuid":"f7dc8445-4a03-4459-9ca1-0e7cd8517a57","attributeTranslation":"Voor het FOSTER onderzoeksplatform : Het aantal en soort analysen uitgevoerd per geregistreerde patiënt","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11153123,"uuid":"f7dc8445-4a03-4459-9ca1-0e7cd8517a57","attributeTranslation":"De l’étude évolutive plateforme FOSTER : nombre et type d'analyses effectuées par patient enregistré","language":34,"languageDescription":"French (France)"}]},{"id":1056190,"number":21,"endPoint":"For FOSTER evolving study platform : Number and type of imaging studies centralized in the imaging repository per registered patient","isPrimary":false,"endPointTranslations":[{"id":11153126,"uuid":"e1277b7d-ab74-4760-ba78-d270d8aaa3d1","attributeTranslation":"W ramach platformy badawczej FOSTER-Evolving : Liczba i rodzaj badań obrazowych zgromadzonych w centralnym repozytorium dla włączonego pacjenta.","language":19,"languageDescription":"Polish"},{"id":11153125,"uuid":"e1277b7d-ab74-4760-ba78-d270d8aaa3d1","attributeTranslation":"Voor het FOSTER onderzoeksplatform : Het aantal en soort beeldvormingsonderzoeken gecentraliseerd in het beeldvormingsarchief per geregistreerde patiënt","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11153128,"uuid":"e1277b7d-ab74-4760-ba78-d270d8aaa3d1","attributeTranslation":"Para la plataforma del estudio FOSTER-evolving: Número y tipo de estudios de imagen centralizados en el repositorio de imágenes por cada paciente registrado.","language":7,"languageDescription":"Spanish"},{"id":11153127,"uuid":"e1277b7d-ab74-4760-ba78-d270d8aaa3d1","attributeTranslation":"Per lo studio evolutivo della piattaforma FOSTER : Numero e tipo di studi di imaging centralizzati nel repository di imaging per paziente registrato","language":14,"languageDescription":"Italian"},{"id":11153124,"uuid":"e1277b7d-ab74-4760-ba78-d270d8aaa3d1","attributeTranslation":"De l’étude évolutive plateforme FOSTER : Nombre et type d'études d'imagerie centralisées dans le référentiel d'imagerie par patient enregistré.","language":34,"languageDescription":"French (France)"}]},{"id":1056191,"number":22,"endPoint":"For FOSTER evolving study platform : Growth plate maturation through bone age","isPrimary":false,"endPointTranslations":[{"id":11153132,"uuid":"4ff3abf8-c963-4112-a75b-6f0938bc2d78","attributeTranslation":"W ramach platformy badawczej FOSTER-Evolving : Dojrzewanie chrząstki wzrostowej poprzez wiek kostny","language":19,"languageDescription":"Polish"},{"id":11153131,"uuid":"4ff3abf8-c963-4112-a75b-6f0938bc2d78","attributeTranslation":"Per lo studio evolutivo della piattaforma FOSTER : Maturazione della cartilagine di accrescimento attraverso l'età ossea","language":14,"languageDescription":"Italian"},{"id":11153129,"uuid":"4ff3abf8-c963-4112-a75b-6f0938bc2d78","attributeTranslation":"Voor het FOSTER onderzoeksplatform : Rijping van de groeischijf gedurende de botleeftijd","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11153133,"uuid":"4ff3abf8-c963-4112-a75b-6f0938bc2d78","attributeTranslation":"Para la plataforma del estudio FOSTER-evolving: Maduración de la placa de crecimiento mediante edad ósea","language":7,"languageDescription":"Spanish"},{"id":11153130,"uuid":"4ff3abf8-c963-4112-a75b-6f0938bc2d78","attributeTranslation":"De l’étude évolutive plateforme FOSTER : Maturation du cartilage de croissance à travers l'âge osseux","language":34,"languageDescription":"French (France)"}]},{"id":1056192,"number":23,"endPoint":"For FOSTER-CabOS (first randomization) : Group comparison on EFS and OS (OS being defined as the time from randomisation to death from any cause. 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