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Three Dimensional Conformal Radiotherapy / Intensity Modulated Radiotherapy alone vs Three Dimensional Conformal Radiotherapy / Intensity Modulated Radiotherapy plus adjuvant hormonal therapy in localized T1b-c, T2a, N0, M0 prostatic carcinoma. A Phase III Randomized Study.

Study documentation

Trial Status LT-FU ongoing
Dates Date of activation: 25-Apr-2001
Date Step1 close: 30-Apr-2008
Data management at EORTC Yes
Design Phase 3
Randomized open label
Targeted Sample size EORTC Groups: 800
Treatment Radiotherapy, Drug
Bicalutamide, Goserelin
Study Staff Michel Bolla (Study Coordinator) , CHU de Grenoble - La Tronche - Hopital A. Michallon, Grenoble
Kin Jip Cheung (Senior Clinical Operations Manager) , EORTC Headquarters, Brussels
Beatrice Fournier (Clinical Scientist) , EORTC Headquarters, Brussels
Julie Hermans (Regulatory Affairs Manager) , EORTC Headquarters, Brussels
Anouk Neven (Statistician) , EORTC Headquarters, Brussels
Type of cancer Prostate
Participating groups EORTC Radiation Oncology Group
Recruiting centers Amsterdam UMC - Locatie AMC (Amsterdam, Netherlands)
Bank Of Cyprus Oncology Centre (Strovolos - Nicosia, Cyprus)
Belfast City Hospital (Belfast, United Kingdom)
CHU Site Sainte-Elisabeth-UCL Namur (Namur, Belgium)
CHU de Grenoble - La Tronche - Hopital A. Michallon (Grenoble, France)
Centre Georges-Francois-Leclerc (Dijon, France)
Centre Hospitalier Universitaire Vaudois - Lausanne (Lausanne, Switzerland)
Centre Leon Berard (Lyon, France)
Centre Oscar Lambret (Lille, France)
Centre Saint-Yves (Vannes, France)
Charite - Universitaetsmedizin Berlin - Campus Mitte (Berlin, Germany)
Clatterbridge NHS -Wirral (Wirral, United Kingdom)
Cliniques Universitaires Saint-Luc (Brussels, Belgium)
GasthuisZusters Antwerpen - Sint-Augustinus (Wilrijk, Belgium)
ICO L’Hospitalet - Hospital Duran i Reynals (Institut Catala D'Oncologia) (L' Hospitalet De Llobregat, Spain)
Institut du Cancer de Montpellier (Montpellier, France)
Institut du Cancer de Montpellier (Montpellier, France)
Instituut Verbeeten (Tilburg, Netherlands)
Ipswich Hospital Nhs Trust (Ipswich, Suffolk, United Kingdom)
Leiden University Medical Centre (Leiden, Netherlands)
Medical University Of Gdansk (Gdansk, Poland)
Nottingham University Hospitals NHS Trust - City Hospital (Nottingham, United Kingdom)
Radiotherapiegroep locatie Arnhem (Arnhem, Netherlands)
St. Luke'S Hospital Rathgar (Dublin, Ireland)
U.Z. Leuven - Campus Gasthuisberg (Leuven, Belgium)
Universita Di Brescia - Azienda Ospedaliera Spedali Civili di Brescia (Brescia, Italy)
Universitair Ziekenhuis Brussel (Brussels, Belgium)
University Hospital Hradec Kralove (Hradec Kralove, Czech Republic)
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 Centro Hospitalar Universitario Lisboa Norte - Hospital Sta. Maria (Lisboa, Portugal)
HELIOS Klinikum Berlin-Buch (Berlin, Germany)
Hopital de La Timone (APHM) (Marseille, France)
United Lincolnshire Hospitals NHS Trust-Lincoln County Hospital (Lincoln, United Kingdom)
UniversitaetsSpital Zurich (Zurich, Switzerland)
Universitaetsklinik Dusseldorf (Duesseldorf, Germany)
Universitaetsklinikum Koeln (Koeln, Germany)
Protocol summary
NCT number NCT00021450
Financial Support EORTC HQ