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.
研究概览
详细说明
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.
研究类型
注册 (预期的)
阶段
- 第三阶段
联系人和位置
学习地点
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Angers、法国、49036
- Centre Paul Papin
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Annecy、法国、74011 Cedex
- Centre hospitalier d'Annecy
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Bordeaux、法国、33076
- Institut Bergonie
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Caen、法国、14076
- Centre Regional Francois Baclesse
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Chalon Sur Saone、法国、71100
- Centre de Radiotherapie du Parc
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Creteil、法国、94010
- Centre Hospitalier Universitaire Henri Mondor
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Lille、法国、59020
- Centre Oscar Lambret
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Limoges、法国、87042
- Centre Hospital Regional Universitaire de Limoges
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Lyon、法国、69373
- Centre Léon Bérard
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Lyon、法国、69008
- Clinique de la Sauvegarde - Clinique Jeanne D'Arc
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Lyon、法国、69008
- Clinique de la Sauvegarde
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Marseille、法国、13273
- Institut J. Paoli and I. Calmettes
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Montpellier、法国、34298
- Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
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Orleans、法国、45067
- CHR D'Orleans - Hopital de la Source
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Paris、法国
- Hôpital d'Instruction des Armées du Val de Grâce
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Pierre Benite、法国、69495
- Centre Hospitalier LYON SUD
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Reims、法国、51056
- Institut Jean Godinot
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Rennes、法国、35064
- Centre Eugene Marquis
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Roanne、法国、F-42300
- CHG Roanne
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Strasbourg、法国、67010
- Clinique de l'Orangerie
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Strasbourg、法国、67085
- Centre Paul Strauss
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Toulouse、法国、31052
- Institut Claudius Regaud
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Valance、法国、26000
- Centre Marie Curie
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
合作者和调查者
赞助
调查人员
- 学习椅：Pascal Pommier, MD、Centre Léon Bérard
出版物和有用的链接
一般刊物
- 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.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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