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TRUSTS : A phase IIb/III multicenter study comparing the efficacy of Trabectedin administered as a 3-hour or 24 hour infusion to doxorubicin in patients with advanced or metastatic untreated soft tissue sarcoma

Study documentation

Trial Status All trial activities ended
Dates Date of activation: 27-May-2011
Date Step1 close: 06-Aug-2012
Data management at EORTC Yes
Design Phase 2-3
Randomized open label
Targeted Sample size EORTC Groups: 250 - All Groups: 370
Treatment Drug
Doxorubicin, Trabectedin
Study Staff Saskia Litiere (Statistician) , EORTC Headquarters, Brussels
Sandrine Marreaud (Clinical Research Physician) , EORTC Headquarters, Brussels
Axelle Nzokirantevye (Data Manager) , EORTC Headquarters, Brussels
Type of cancer Soft Tissue and Bone Sarcoma
Participating groups EORTC Soft Tissue and Bone Sarcoma Group
Sarcoma Alliance for Research through Collaboration
Recruiting centers Carolinas Medical Center (Charlotte, United States of America)
Centre Georges-Francois-Leclerc (DIJON CEDEX, France)
Centre Leon Berard (Lyon, France)
Centre Oscar Lambret (LILLE CEDEX, France)
Dana-Farber Cancer Institute & Harvard Medical School (Boston, United States of America)
Erasmus MC (Rotterdam, Netherlands)
Herlev Hospital - University Copenhagen (Herlev, Denmark)
Hopital de La Timone (APHM) (MARSEILLE CEDEX 5, France)
Hospital Universitari Vall d’Hebron -Vall d'Hebron Institut Oncologia (Barcelona, Spain)
Hospital Universitario San Carlos (Madrid, Spain)
Institut Bergonie (Bordeaux, France)
Institut Curie- Hopital de Paris (PARIS CEDEX 05, France)
Institut Jules Bordet (Brussels, Belgium)
Institut de Cancerologie de l’Ouest (ICO) - Saint Herblain (ST HERBALAIN CEDEX, France)
Leiden University Medical Centre (Leiden, Netherlands)
Ludwig-Maximilians-Universitaet Muenchen - Campus Grosshadern (Muenchen, Germany)
Massachussets General Hospital Cancer Center (Boston, United States of America)
Nebraska Methodist Hospital (Omaha, United States of America)
Pennsylvania Oncology Hematology Associates (Philadelphia, United States of America)
Radboud University Medical Center Nijmegen (Nijmegen, Netherlands)
Sarcoma Oncology Center (Santa Monica, United States of America)
Stanford Hospital and Clinics (Stanford, United States of America)
The Christie NHS Foundation Trust (Manchester, United Kingdom)
The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis (Amsterdam, Netherlands)
U.Z. Leuven - Campus Gasthuisberg (Leuven, Belgium)
UniversitaetsMedizin Mannheim (Mannheim, Germany)
Universitaetsklinikum Carl Gustav Carus (Dresden, Germany)
Universitaetsklinikum Koeln (Koeln, Germany)
Universitaetsklinikum Wien - AKH uniklinieken (Vienna, Austria)
University Medical Center Groningen (Groningen, Netherlands)
University Of Iowa Hospital And Clinics (Iowa City, United States of America)
Centers to be activated Aarhus University Hospital (Aarhus, Denmark)
Cliniques Universitaires Saint-Luc (Brussels, Belgium)
Gustave Roussy (VILLEJUIF CEDEX, France)
Helios Klinikum Bad Saarow (Bad Saarow-Pieskow, Germany)
Maria Sklodowska-Curie National Research Institute of Oncology (Warsaw, Poland)
Medizinische Hochschule Hannover (Hannover, Germany)
Military Hospital - State Health Centre (Budapest, Hungary)
NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital (Glasgow, United Kingdom)
National Cancer Institute - Bratislava (Bratislava, Slovakia)
Nottingham University Hospitals NHS Trust - City Hospital (Nottingham, United Kingdom)
UKE - University Cancer Center (Hamburg, Germany)
University Hospital Motol (Prague, Czech Republic)
Protocol summary
NCT number NCT01189253
EudraCT 2009-014889-26
Financial Support Educational Grant