NCT00002511已完成3 期
PHASE III STUDY OF POST-OPERATIVE EXTERNAL RADIOTHERAPY IN PATHOLOGICAL STAGE T3 N0 PROSTATIC CARCINOMA
European Organisation for Research and Treatment of Cancer - EORTC1 个研究点 分布在 1 个国家目标入组 1,005 人开始时间: 1992年12月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,005
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells and may be an effective treatment for prostate cancer.
PURPOSE: Randomized phase III trial to compare radiation therapy with no further treatment in treating patients with stage III prostate cancer following radical prostatectomy.
详细描述
OBJECTIVES:
- Compare local recurrence rates, acute and late morbidity, overall survival, disease-free survival, and cancer-related survival of patients with pT3 pN0 adenocarcinoma of the prostate randomized following radical prostatectomy to postoperative conventional pelvic irradiation (60 Gy) vs no further treatment until relapse.
- Better define the selective pathologic indications for radiotherapy in patients with pT3 pN0 disease.
OUTLINE: This is a randomized study.
- Arm I: Patients undergo radiotherapy daily, 5 days a week, for 5 weeks, followed by boost radiotherapy for 1-1.4 weeks.
- Arm II: Patients are observed. Local relapse is treated with conventional pelvic radiotherapy.
Patients are followed every 3 months during the first postoperative year, every 6 months until the fifth year, and annually thereafter.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- — 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically documented invasive adenocarcinoma of the prostate staged pT3 pN0 after radical prostatectomy
- •Preoperative staging must have been T0-3 N0 M0 based on physical exam, chest x-ray, bone scan, CT or MRI of entire pelvis and abdomen, and serum PSA
- •At least 1 of the following features must be present:
- •Complete capsule invasion (i.e., perforation)
- •Positive surgical margins (microscopic or gross)
- •Seminal vesicle invasion
- •Radiotherapy must begin within 16 weeks following surgery, after recovery of urinary function
- •PATIENT CHARACTERISTICS:
- •75 and under
- •Performance status:
- •Hematopoietic:
- •Not specified
- •Not specified
- •Not specified
- •No other malignancies
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •Not specified
- •Endocrine therapy:
- •No more than 4 months of preoperative hormonal therapy
- •Radiotherapy:
- •Not specified
- •Radical prostatectomy required within 12 weeks with recovery of urinary function
排除标准
- 未提供
研究者
研究点 (1)
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