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A Phase III Randomised Double-blind Study Comparing Sorafenib With Placebo In Patients With Resected Primary Renal Cell Carcinoma at High or Intermediate Risk of Relapse

Study documentation

Trial Status Closed to Patient Entry
Dates Date of activation: 23-Mar-2009
Date Step1 close: 12-Apr-2013
Data management at EORTC No
Design Phase 3
Randomized blind
Targeted Sample size EORTC Groups: 200 - All Groups: 1656
Treatment Drug
Study Staff Steven Joniau (Study Coordinator) , U.Z. Leuven - Campus Gasthuisberg, Leuven
Laurence Collette (Statistician) laurence.collette (at), EORTC Headquarters, Brussels
Maarten De Rouck (Data Manager) maarten.derouck (at), EORTC Headquarters, Brussels
Stephanie Kromar (Regulatory Affairs Manager) stephanie.kromar (at), EORTC Headquarters, Brussels
Sandrine Marreaud (Clinical Research Physician) sandrine.marreaud (at), EORTC Headquarters, Brussels
Sara Meloen (Pharmacovigilance Manager) sara.meloen (at), EORTC Headquarters, Brussels
Type of cancer Kidney
Participating groups EORTC Genito-Urinary Cancers Group
University College of London
Recruiting centers Cliniques Universitaires Saint-Luc (Brussels, Belgium) - Inst. 121
Erasmus MC Cancer Institute - location Daniel den Hoed (Rotterdam, Netherlands) - Inst. 302
Hopitaux Universitaires Bordet-Erasme - Institut Jules Bordet (Brussels, Belgium) - Inst. 101
Onze Lieve Vrouw Ziekenhuis (Aalst, Belgium) - Inst. 150
Radboud University Medical Center Nijmegen (Nijmegen, Netherlands) - Inst. 304
Universitair Ziekenhuis Gent (Gent, Belgium) - Inst. 104
Centers to be activated The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis (Amsterdam, Netherlands) - Inst. 301
U.Z. Leuven - Campus Gasthuisberg (Leuven, Belgium) - Inst. 147
University Medical Center Groningen (Groningen, Netherlands) - Inst. 335
University Medical Center Groningen (Groningen, Netherlands) - Inst. 335
Protocol summary
NCT number NCT00492258
EudraCT 2006-006079-19