EORTC protocol 22043 - 30041

Immediate or early salvage post-operative external radiotherapy combined with concomitant and adjuvant hormonal treatment versus immediate or early salvage post-operative external radiotherapy alone in pT3a-b R0-1 cNOMO/pT2R1 cN0M0, Gleason score 5-10 prostatic carcinoma. A phase III study.
Trial StatusRecruiting
DatesDate of activation: 18-May-09
Data management at EORTCFull
Phase3
Randomized trialYes
TypeAdjuvant
Targeted Sample sizeEORTC Groups: 600 - All Groups: 600
Number of steps1
DrugLeuprorelin
Study StaffMichel Bolla (Study Coordinator) - CHU de Grenoble - La Tronche - Hôpital A. Michallon, Grenoble
Steven Joniau (Study Coordinator) - U.Z. Leuven - Campus Gasthuisberg, Leuven
Laurence Collette (Statistician) - EORTC Headquarters, Brussels
Isabelle Meulders (Data Manager) - EORTC Headquarters, Brussels
Denis Lacombe (Coordinating Physician) - EORTC Headquarters, Brussels
Anne Kirkpatrick (Project Manager) - EORTC Headquarters, Brussels, anne.kirkpatrick( at )eortc.be, +32 27741691
Type of cancerProstate
Participating GroupsEORTC Radiation Oncology Group(Coordinating Group)
EORTC Genito-Urinary Cancers Group
Centers authorized by EORTC Hôpitaux Universitaires Bordet-Erasme - Institut Jules Bordet (Brussels, Belgium) - Inst. 101
Universitair Ziekenhuis Gent (Gent, Belgium) - Inst. 104
Cliniques Universitaires St. Luc (Brussels, Belgium) - Inst. 121
U.Z. Leuven - Campus Gasthuisberg (Leuven, Belgium) - Inst. 147
AZ Turnhout - Campus Sint Elisabeth (Turnhout, Belgium) - Inst. 151
AZ Groeninge Kortrijk - Campus Vercruysselaan (Kortrijk, Belgium) - Inst. 156
Hopital De Jolimont (Haine St Paul, Belgium) - Inst. 474
Clinique et Maternité Sainte Elisabeth (Namur, Belgium) - Inst. 1201
Virga Jesse Hospital (Hasselt, Belgium) - Inst. 1217
Algemeen Ziekenhuis Sint-Augustinus (Wilrijk, Belgium) - Inst. 1234
Bank Of Cyprus Oncology Centre (Strovolos - Nicosia, Cyprus) - Inst. 3607
CHU de Grenoble - La Tronche - Hôpital A. Michallon (Grenoble, France) - Inst. 215
Institut Gustave Roussy (Villejuif, France) - Inst. 225
Centre Leon Berard (Lyon, France) - Inst. 227
Centre Georges-Francois-Leclerc (Dijon, France) - Inst. 229
CHRU de Besancon - Hopital Jean Minjoz (Besancon, France) - Inst. 422
Institut régional du Cancer Montpellier (Montpellier, France) - Inst. 429
Heinrich-Heine Universitaetsklinik Dusseldorf (Duesseldorf, Germany) - Inst. 483
Universitaetsklinikum - Essen (Essen, Germany) - Inst. 509
Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin (Berlin, Germany) - Inst. 523
Institut Catala d'Oncologia - ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia) (Badalona - (barcelona), Spain) - Inst. 381
Hospital De Navarra (Pamplona, Spain) - Inst. 938
Hospital Del Mar (Barcelona, Spain) - Inst. 959
Institut Catala d'Oncologia - ICO L’Hospitalet - Hospital Duran i Reynals (Institut Catala D'Oncologia) (L'Hospitalet de Llobregat, Spain) - Inst. 6225
Radio-Onkologie Berner Oberland AG (Thun, Switzerland) - Inst. 9324
Hôpitaux universitaires de Genève - HUG - site de Cluse-Roseraie (Geneve, Switzerland) - Inst. 451
Inselspital (Bern, Switzerland) - Inst. 454
Centre Hospitalier Universitaire Vaudois (Lausanne, Switzerland) - Inst. 457
Ospedale Regionale Bellinzona e Valli (Bellinzona, Switzerland) - Inst. 459
The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis (Amsterdam, The Netherlands) - Inst. 301
Leiden University Medical Centre (Leiden, The Netherlands) - Inst. 310
Isala Klinieken - Locatie Sophia (Zwolle, The Netherlands) - Inst. 328
University Medical Center Groningen (Groningen, The Netherlands) - Inst. 335
Erasmus MC (Rotterdam, The Netherlands) - Inst. 336
Maastro Clinic - Maastricht Radiation Oncology (Maastricht, The Netherlands) - Inst. 4900
Protocol summaryCancer.gov (PDQ)
ClinicalTrials.gov
NCT numberNCT00949962
EudraCT2006-002772-17
Protocol documents in PDF
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Study documentation
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