Clinical Trial Details


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

Study documentation Publications

Trial Status Closed to Patient Entry
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
Claire Gandilhon (Clinical Trial Assistant) claire.gandilhon (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
Bart Meulemans (Data Manager) bart.meulemans (at), EORTC Headquarters, Brussels
Evelien Nollet (Project Manager) evelien.nollet (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
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) - Inst. 130
AZ Groeninge – Oncology Centre (Kortrijk, Belgium) - Inst. 1257
Academisch Medisch Centrum - Universiteit van Amsterdam (Amsterdam, Netherlands) - Inst. 342
Academisch Ziekenhuis Maastricht (Maastricht, Netherlands) - Inst. 324
Barts Health NHS Trust - St. Bartholomew'S Hospital (London, United Kingdom) - Inst. 558
Basildon University Hospital (Basildon, United Kingdom) - Inst. 9174
Centre Hospitalier de l'Université de Montreal - Pavillon Saint-Luc (Montreal, Quebec, Canada) - Inst. 1785
Cliniques Universitaires Saint-Luc (Brussels, Belgium) - Inst. 121
Diamond Health Care Centre (Vancouver, Canada) - Inst. 9374
Hopitaux Universitaires Bordet- Institut Jules Bordet (Brussels, Belgium) - Inst. 101
Imperial College Healthcare NHS Trust - Charing Cross Hospital (London, United Kingdom) - Inst. 603
Jeroen Bosch Ziekenhuis ('s-Hertogenbosch, Netherlands) - Inst. 22
Jessa Ziekenhuis - Campus Virga Jesse (Hasselt, Belgium) - Inst. 1217
Leeds Teaching Hospitals NHS Trust - St. James's University Hospital (Leeds, United Kingdom) - Inst. 601
Montreal General Hospital (Montreal, Canada) - Inst. 181
Onze Lieve Vrouw Ziekenhuis (Aalst, Belgium) - Inst. 150
Queen Elizabeth II Health Sciences Centre (Halifax, Canada) - Inst. 9373
Radboud University Medical Center Nijmegen (Nijmegen, Netherlands) - Inst. 304
Royal Free Hospital (London, United Kingdom) - Inst. 598
Royal United Hospital (Bath, United Kingdom) - Inst. 683
San Camillo Forlanini Hospitals (Roma, Italy) - Inst. 796
Singleton Hospital (Swansea, United Kingdom) - Inst. 669
St. Antonius Ziekenhuis (Nieuwegein, Netherlands) - Inst. 81
The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis (Amsterdam, Netherlands) - Inst. 301
Universitair Ziekenhuis Gent (Gent, Belgium) - Inst. 104
University Health Network - Oci / Princess Margaret Hospital (Toronto, Canada) - Inst. 754
University Hospitals Bristol NHS Foundation Trust - Bristol Haematology And Oncology Centre (Bristol, United Kingdom) - Inst. 664
University Medical Center Groningen (Groningen, Netherlands) - Inst. 335
Velindre NHS Trust - Velindre Cancer Centre (Cardiff, United Kingdom) - Inst. 626
Vrije Universiteit Medisch Centrum (Amsterdam, Netherlands) - Inst. 308
Centers to be activated Azienda Ospedaliera Città della Salute e della Scienza di Torino - Ospedale Molinette (Torino, Italy) - Inst. 720
Ospedale B. Ramazzini (Carpi, Italy) - Inst. 706
Ospedale S. Luigi Gonzaga - Universita Di Torino (Orbassano-Torino, Italy) - Inst. 797
Universita Di Brescia - Azienda Ospedaliera Spedali Civili di Brescia (Brescia, Italy) - Inst. 741
Universitair Medisch Centrum - Academisch Ziekenhuis (Utrecht, Netherlands) - Inst. 306
Protocol summary
NCT number NCT01099423