NCT00548600已完成3 期
A Randomized Clinical Trial Comparing Radical Radiotherapy by External Beam Radiation Versus Radical Radiotherapy Using a Combination of a Temporaory Iridium Implant Plus External Beam Radiation in Surgically Staged B2 and C Carcinoma of the Prostate
Ontario Clinical Oncology Group (OCOG)2 个研究点 分布在 1 个国家目标入组 112 人开始时间: 1992年5月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- Rate of local control as determined by biopsy at 18 months
研究概览
简要总结
The specific objective of this study is to compare the relative efficacy of the combination of a temporary iridium implant plus external beam irradiation versus standard external beam irradiation alone in patients with Stage B2 and C prostatic carcinoma. Benefit will be assessed in terms of local recurrence, survival, and toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 75 Years（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •All patients must have histologically proven adenocarcinoma of the prostate
- •The primary tumour should be staged clinically B2 or C as classified by A.J.C. Staging System
排除标准
- •Patients requiring transurethral prostatectomy (TURP) prior to diagnosis
- •Presence of metastases identified by bone scan, chest x-ray or CT scan of the abdomen and pelvis, or staging lymphadenectomy
- •Karnofsky performance status less than 80
- •Inadequate laboratory results: i.e. Hb < 12 gm/litre, WBC < 3.5 x 10 per litre, platelets < 100 x 10/litre, urea > 13 mmol/litre, creatinine > 220 mmol/litre
- •Unfit for surgery for other medical reasons
- •Age above 75 years
- •Failure to provide written informed consent
结局指标
主要结局
Rate of local control as determined by biopsy at 18 months
时间窗: 18-months
次要结局
- Mortality due to prostate cancer(survival)
- Distant metastasis(survival)
- Overall mortality(survival)
- Local complications of radiation(2-5 years)
研究者
研究点 (2)
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