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Randomized Phase III trial comparing immediate versus deferred nephrectomy in patients with synchronous metastatic renal cell carcinoma.

Study documentation

Trial Status LT-FU ongoing
Dates Date of activation: 21-Apr-2010
Date Step1 close: 29-Apr-2016
Data management at EORTC Yes
Design Phase 3
Randomized open label
Targeted Sample size EORTC Groups: 300 - All Groups: 458
Treatment Surgery
Study Staff Axel Bex (Study Coordinator) , The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis, Amsterdam
John B.A.G. Haanen (Study Coordinator) , The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis, Amsterdam
Beatrice Fournier (Clinical Scientist) , EORTC Headquarters, Brussels
Claire Gandilhon (Clinical Operations Assistant) , EORTC Headquarters, Brussels
Joanna Krzystyniak (Clinical Operations Manager) , EORTC Headquarters, Brussels
Sandrine Marreaud (Clinical Research Physician) , EORTC Headquarters, Brussels
Sara Meloen (Pharmacovigilance Manager) , EORTC Headquarters, Brussels
Bart Meulemans (Data Manager) , EORTC Headquarters, Brussels
Gilles Sarlet (Regulatory Affairs Manager) , EORTC Headquarters, Brussels
Laurens Vinckier (Pharmacovigilance Manager) , EORTC Headquarters, Brussels
Gaetan de Schaetzen (Senior Clinical Operations Manager) , EORTC Headquarters, Brussels
Type of cancer Kidney
Participating groups EORTC Genito-Urinary Cancers Group
National Cancer Research Institute - Renal Cancer Group
Canadian Urologic Oncology Group
Recruiting centers AZ Damiaan (Oostende, Belgium)
AZ Groeninge – Oncology Centre (Kortrijk, Belgium)
Amsterdam UMC - Locatie AMC (Amsterdam, Netherlands)
Amsterdam UMC - locatie VUMC (Amsterdam, Netherlands)
Barts Health NHS Trust - St. Bartholomew'S Hospital (London, United Kingdom)
Centre Hospitalier de l'Université de Montreal (Montreal, Quebec, Canada)
Cliniques Universitaires Saint-Luc (Brussels, Belgium)
Diamond Health Care Centre (Vancouver, Canada)
Imperial College Healthcare NHS Trust - Charing Cross Hospital (London, United Kingdom)
Jessa Ziekenhuis - Campus Virga Jesse (Hasselt, Belgium)
Leeds Teaching Hospitals NHS Trust - St. James's University Hospital (Leeds, United Kingdom)
Mid and South Essex NHS - Basildon University Hospital (Basildon, United Kingdom)
Montreal General Hospital (Montreal, Canada)
Queen Elizabeth II Health Sciences Centre (Halifax, Canada)
Radboud University Medical Center Nijmegen (Nijmegen, Netherlands)
Royal Free Hospital (London, United Kingdom)
Royal United Hospitals Bath NHS Foundation Trust - Royal United Hospital (Bath, United Kingdom)
San Camillo Forlanini Hospitals (Roma, Italy)
Singleton Hospital (Swansea, United Kingdom)
St. Antonius Ziekenhuis (Nieuwegein, Netherlands)
The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis (Amsterdam, Netherlands)
UMC-Academisch Ziekenhuis Utrecht (Utrecht, Netherlands)
Universitair Ziekenhuis Gent (Gent, Belgium)
University Health Network - Oci / Princess Margaret Hospital (Toronto, Canada)
University Hospitals Bristol NHS Foundation Trust - Bristol Haematology And Oncology Centre (Bristol, United Kingdom)
University Medical Center Groningen (Groningen, Netherlands)
Velindre NHS Trust - Velindre Cancer Centre (Cardiff, United Kingdom)
Centers to be activated Azienda Ospedaliera Città della Salute e della Scienza di Torino - Ospedale Molinette (Torino, Italy)
Universita Di Brescia - Azienda Ospedaliera Spedali Civili di Brescia (Brescia, Italy)
Universita Di Torino - Ospedale S. Luigi Gonzaga (Orbassano-Torino, Italy)
Protocol summary
NCT number NCT01099423
Financial Support Educational Grant