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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
Beatrice Fournier (Clinical Scientist) beatrice.fournier (at), EORTC Headquarters, Brussels
Joanna Krzystyniak (Clinical Operations Manager) joanna.krzystyniak (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
Gilles Sarlet (Regulatory Affairs Manager) gilles.sarlet (at), EORTC Headquarters, Brussels
Laurens Vinckier (Pharmacovigilance Manager) laurens.vinckier (at), EORTC Headquarters, Brussels
Gaetan de Schaetzen (Clinical Operations Manager) gaetan.deschaetzen (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)
Erasmus MC (Rotterdam, Netherlands)
Institut Jules Bordet-Hopital Universitaire ULB (Brussels, Belgium)
Onze Lieve Vrouw Ziekenhuis (Aalst, Belgium)
Radboud University Medical Center Nijmegen (Nijmegen, Netherlands)
U.Z. Leuven - Campus Gasthuisberg (Leuven, Belgium)
Universitair Ziekenhuis Gent (Gent, Belgium)
Centers to be activated The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis (Amsterdam, Netherlands)
University Medical Center Groningen (Groningen, Netherlands)
University Medical Center Groningen (Groningen, Netherlands)
Protocol summary
NCT number NCT00492258
EudraCT 2006-006079-19