Radiation Therapy in Treating Patients With Stage I, Stage II, or Stage III Prostate Cancer
Phase III Randomized Study of Radiotherapy to the Prostate With or Without Radiotherapy to the Pelvis in Patients With Stage I, II, or III Adenocarcinoma of the Prostate
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether radiation therapy to the prostate and pelvis is more effective than radiation therapy to the prostate alone in treating prostate cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy to the prostate with or without radiation to the pelvis in treating patients with stage I, stage II, or stage III prostate cancer.
연구 개요
상세 설명
OBJECTIVES:
- Compare the survival without recurrence and overall survival of patients with stage I, II, or III adenocarcinoma of the prostate after receiving radiotherapy to the prostate with or without radiotherapy to the pelvis.
- Compare the toxic effects of these two regimens in these patients.
- Compare the quality of life of patients treated with these regimens.
- Determine the prognostic factors of progression in these patients.
- Analyze the site of relapse (prostate, pelvic lymph nodes, metastases) in case of progression in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified by participating center and prognostic group (poor vs good prognosis).
Patients are randomized to one of two treatment arms.
- Arm I: Patients receive pelvic irradiation plus local prostate irradiation.
- Arm II: Patients receive local prostate irradiation only. Radiotherapy in both arms is administered 5 days a week for 7 weeks.
Quality of life is assessed before therapy, 12 months after therapy, and then annually thereafter.
Patients are followed at 2 and 6 months and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 450 patients will be accrued for this study within 4 years.
연구 유형
등록 (예상)
단계
- 3단계
연락처 및 위치
연구 장소
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Angers, 프랑스, 49036
- Centre Paul Papin
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Annecy, 프랑스, 74011 Cedex
- Centre hospitalier d'Annecy
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Bordeaux, 프랑스, 33076
- Institut Bergonie
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Caen, 프랑스, 14076
- Centre Regional Francois Baclesse
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Chalon Sur Saone, 프랑스, 71100
- Centre de Radiotherapie du Parc
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Creteil, 프랑스, 94010
- Centre Hospitalier Universitaire Henri Mondor
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Lille, 프랑스, 59020
- Centre Oscar Lambret
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Limoges, 프랑스, 87042
- Centre Hospital Regional Universitaire de Limoges
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Lyon, 프랑스, 69373
- Centre Léon Bérard
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Lyon, 프랑스, 69008
- Clinique de la Sauvegarde - Clinique Jeanne D'Arc
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Lyon, 프랑스, 69008
- Clinique de la Sauvegarde
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Marseille, 프랑스, 13273
- Institut J. Paoli and I. Calmettes
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Montpellier, 프랑스, 34298
- Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
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Orleans, 프랑스, 45067
- CHR D'Orleans - Hopital de la Source
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Paris, 프랑스
- Hôpital d'Instruction des Armées du Val de Grâce
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Pierre Benite, 프랑스, 69495
- Centre Hospitalier LYON SUD
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Reims, 프랑스, 51056
- Institut Jean Godinot
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Rennes, 프랑스, 35064
- Centre Eugene Marquis
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Roanne, 프랑스, F-42300
- CHG Roanne
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Strasbourg, 프랑스, 67010
- Clinique de l'Orangerie
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Strasbourg, 프랑스, 67085
- Centre Paul Strauss
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Toulouse, 프랑스, 31052
- Institut Claudius Regaud
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Valance, 프랑스, 26000
- Centre Marie Curie
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
DISEASE CHARACTERISTICS:
Histologically proven adenocarcinoma of the prostate
- Stage I (T1b or T1c, N0, M0)
- Stage II (T2, N0, M0)
- Stage III (T3, N0, M0)
Poor prognosis (high risk of lymph node invasion) defined as meeting at least 1 of the following criteria:
- Gleason score at least 7
- Prostate-specific antigen (PSA) at least 3 times upper limit of normal (ULN)
- T3 OR
Good prognosis defined as meeting 1 of the following criteria:
- T1b or T2
- T1c with Gleason score less than 7 and PSA less than 3 times ULN
- No metastases by bone scans or chest x-ray
PATIENT CHARACTERISTICS:
Age:
- 75 and under
Performance status:
- Karnofsky 70-100%
Life expectancy:
- More than 10 years
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- No other malignancy within the past 10 years except basal cell skin cancer
- No adenopathies
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- Not specified
Endocrine therapy:
- At least 2-6 months since prior hormonal therapy, if duration no greater than 4-8 months
- No concurrent luteinizing hormone-releasing hormone agonists
- No concurrent anti-androgen therapy
- No concurrent hormonal therapy in high-risk group
Radiotherapy:
- No prior pelvic radiotherapy
Surgery:
- No prior lymphadenectomy
- No prior surgical castration
- No prior prostatectomy
- At least 1 month since prior transurethral resection
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
공동 작업자 및 조사자
스폰서
수사관
- 연구 의자: Pascal Pommier, MD, Centre Léon Bérard
간행물 및 유용한 링크
일반 간행물
- Pommier P, Chabaud S, Lagrange JL, Richaud P, Lesaunier F, Le Prise E, Wagner JP, Hay MH, Beckendorf V, Suchaud JP, Pabot du Chatelard PM, Bernier V, Voirin N, Perol D, Carrie C. Is there a role for pelvic irradiation in localized prostate adenocarcinoma? Preliminary results of GETUG-01. J Clin Oncol. 2007 Dec 1;25(34):5366-73. doi: 10.1200/JCO.2006.10.5171.
- Pommier P, Perol D, Lagrange J, et al.: Does pelvis and prostate radiation therapy compared to prostate radiation therapy alone improve survival in patients with non metastatic prostate carcinoma? Preliminary results of the prospective randomized GETUG 01 trial. [Abstract] Int J Radiat Oncol Biol Phys 63 (Suppl 1): A-33, S19, 2005.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
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처음 게시됨 (추정)
연구 기록 업데이트
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추가 정보
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