EORTC-1447-STBSG

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Maintenance therapy with trabectedin versus observation after first line treatment with doxorubicin of patients with advanced or metastatic soft tissue sarcoma

Study documentation

Trial Status	All trial activities ended
Dates	Date of activation: 21-Aug-2017 Date Step1 close: 29-Aug-2018
Data management at EORTC	Yes
Design	Phase 3 Randomized open label
Targeted Sample size	EORTC Groups: 90 - All Groups: 90
Treatment	Drug Trabectedin
Study Staff	Hans (Andre Johan) Gelderblom (Study Coordinator) , Leiden University Medical Centre, Leiden Laura De Meulemeester (Senior Clinical Operations Manager) , EORTC Headquarters, Brussels Stephanie Kromar (Regulatory Affairs Manager) , EORTC Headquarters, Brussels Saskia Litiere (Statistician) , EORTC Headquarters, Brussels Livia Meirsman (Project Manager) , EORTC Headquarters, Brussels Sandrine Rivrain (Pharmacovigilance Manager) , EORTC Headquarters, Brussels Ionela Stanciu (Clinical Operations Manager) , EORTC Headquarters, Brussels
Type of cancer	Soft Tissue and Bone Sarcoma
Participating groups	EORTC Soft Tissue and Bone Sarcoma Group
Recruiting centers	Centre Leon Berard (Lyon, France) Centre Oscar Lambret (LILLE CEDEX, France) Gustave Roussy (VILLEJUIF CEDEX, France) Hopital de La Timone (APHM) (MARSEILLE CEDEX 5, France) Hospital Universitario San Carlos (Madrid, Spain) ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia) (Badalona - (Barcelona), Spain) ICO L’Hospitalet - Hospital Duran i Reynals (Institut Catala D'Oncologia) (L' Hospitalet De Llobregat, Spain) Institut Bergonie (Bordeaux, France) Institut Curie- Hopital de Paris (PARIS CEDEX 05, France) Leiden University Medical Centre (Leiden, Netherlands) Maria Sklodowska-Curie National Research Institute of Oncology (Warsaw, Poland) Medizinische Hochschule Hannover (Hannover, Germany) Nottingham University Hospitals NHS Trust - City Hospital (Nottingham, United Kingdom) Royal Marsden Hospital - Chelsea, London (London, United Kingdom) UniversitaetsMedizin Mannheim (Mannheim, Germany) University Medical Center Groningen (Groningen, Netherlands)
Centers to be activated	Bank Of Cyprus Oncology Centre (Strovolos - Nicosia, Cyprus) IRCCS - Fondazione Piemonte Inst di Candiolo (Candiolo (Torino), Italy) Policlinico Universitario Campus Bio-Medico- Oncology Center (Roma, Italy) Univ. of Florence -Azienda Ospedaliero-Universitaria Careggi (Firenze, Italy) University Hospital Virgen del Rocio (Sevilla, Spain)
Protocol summary	http://clinicaltrials.gov/study/NCT02929394
NCT number	NCT02929394
EudraCT	2016-003535-38
Financial Support	Educational Grant