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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
Study Staff Hans (Andre Johan) Gelderblom (Study Coordinator) , Leiden University Medical Centre, Leiden
Laura De Meulemeester (Clinical Operations Manager) , EORTC Headquarters, Brussels
Stephanie Kromar (Regulatory Affairs Manager) , EORTC Headquarters, Brussels
Saskia Litiere (Statistician) , EORTC Headquarters, Brussels
Sandrine Marreaud (Clinical Research Physician) , EORTC Headquarters, Brussels
Livia Meirsman (Project Manager) , EORTC Headquarters, Brussels
Christine Olungu (Data Manager) , EORTC Headquarters, Brussels
Miguel Remis (Clinical Research Associate/Monitor) , EORTC Headquarters, Brussels
Sandrine Rivrain (Pharmacovigilance Manager) , EORTC Headquarters, Brussels
Ionela Stanciu (Clinical Operations Manager) , EORTC Headquarters, Brussels
Xiao Mang Zhou (Junior RAM) , 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 Azienda Ospedaliero-Universitaria Careggi (Firenze, Italy)
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)
University Hospital Virgen del Rocio (Sevilla, Spain)
Protocol summary
NCT number NCT02929394
EudraCT 2016-003535-38
Financial Support Educational Grant