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Sponsored by: |
European Organization for Research and Treatment of Cancer |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00021450 |
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Bicalutamide and goserelin may fight prostate cancer by reducing the production of testosterone. It is not yet known if radiation therapy is more effective with or without bicalutamide and goserelin in treating prostate cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without bicalutamide and goserelin in treating patients who have localized prostate cancer.
Condition | Intervention | Phase |
---|---|---|
Prostate Cancer |
Drug: bicalutamide Drug: goserelin Procedure: adjuvant therapy Procedure: radiation therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | Three Dimensional Conformal Radiotherapy / Intensity Modulated Radiotherapy Alone Vs Three Dimensional Conformal Therapy / Intensity Modulated Radiotherapy Plus Adjuvant Hormonal Therapy In Localized T1b-c, T2a, N0, M0 Prostatic Carcinoma. A Phase III Randomized Study |
Estimated Enrollment: | 800 |
Study Start Date: | April 2001 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to tumor class (T1b-c vs T2a), initial prostate-specific antigen level (10 ng/mL vs 10-20 ng/mL vs greater than 20 ng/mL), Gleason score (2-6 vs 7-10) and participating center. Patients are randomized to 1 of 2 treatment arms.
Quality of life is assessed at baseline and then at months 6, 12, 24, and 36.
Patients are followed every 6 months for 5 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 800 patients (400 per treatment arm) will be accrued for this study within 5 years.
Ages Eligible for Study: | up to 80 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed stage II prostate cancer
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Belgium | |
Academisch Ziekenhuis der Vrije Universiteit Brussel | |
Brussels, Belgium, 1090 | |
Cliniques Universitaires Saint-Luc | |
Brussels, Belgium, 1200 | |
U.Z. Gasthuisberg | |
Leuven, Belgium, B-3000 | |
Cyprus | |
Bank Of Cyprus Oncology Centre | |
Nicosia, Cyprus, 2006 Strovolos | |
Czech Republic | |
Charles University Hospital | |
Hradec Kralove, Czech Republic, 500 05 | |
France | |
CHU de Grenoble - Hopital de la Tronche | |
Grenoble, France, 38043 | |
Centre d'Oncologie Saint-Yves | |
Vannes, France, 56001 | |
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz | |
Besancon, France, 25030 | |
Centre Paul Strauss | |
Strasbourg, France, 67085 | |
Centre de Lutte Contre le Cancer Georges-Francois Leclerc | |
Dijon, France, 21079 | |
Ireland | |
Saint Luke's Hospital | |
Dublin, Ireland, 6 | |
Italy | |
Istituto Nazionale per la Ricerca sul Cancro | |
Genoa, Italy, 16132 | |
Spedali Civili di Brescia | |
Brescia, Italy, 25124 | |
Luxembourg | |
Hopital de la Ville D'Esch-sur-Alzette | |
Esch-sur-Alzette, Luxembourg, L-4240 | |
Netherlands | |
Arnhems Radiotherapeutisch Instituut | |
Arnhem, Netherlands, 6815 AD | |
Dr. Bernard Verbeeten Instituut | |
Tilburg, Netherlands, 5042 SB | |
University Medical Center Groningen | |
Groningen, Netherlands, 9700 RB | |
Poland | |
Medical University of Gdansk | |
Gdansk, Poland, 80-211 | |
Spain | |
Institut Catala d'Oncologia - Hospital Duran i Reynals | |
Barcelona, Spain, 08907 | |
United Kingdom, Northern Ireland | |
Belfast City Hospital Trust Incorporating Belvoir Park Hospital | |
Belfast, Northern Ireland, United Kingdom, BT8 8JR |
Investigator: | Michel Bolla, MD | CHU de Grenoble - Hopital de la Tronche |
Study ID Numbers: | CDR0000068749, EORTC-22991 |
Study First Received: | July 13, 2001 |
Last Updated: | December 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00021450 |
Health Authority: | United States: Federal Government |
stage II prostate cancer |
Prostatic Diseases Genital Neoplasms, Male Goserelin Bicalutamide |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms Carcinoma |
Androgen Antagonists Neoplasms Neoplasms by Site Antineoplastic Agents, Hormonal Antineoplastic Agents |
Hormone Antagonists Therapeutic Uses Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Pharmacologic Actions |