NCT02271659Unknown不适用
Medical and Economic Evaluation of an External Beam Radiotherapy Combined With a Brachytherapy Boost Compared With an Exclusive External Beam Radiotherapy for Intermediate-risk Prostate Cancer
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 298
- 试验地点
- 58
- 主要终点
- Comparison of the biochemical relapse free survival of the patients in two groups at 5 years for an external beam radiotherapy with a brachytherapy boost versus an exclusive external beam radiotherapy
研究概览
简要总结
The aim of the present phase III study is two-folded: 1) to show a superiority of external beam radiotherapy combined with a brachytherapy boost versus exclusive external beam radiotherapy and 2) to evaluate the economic impact of each treatment.
The study includes 33 cancer centres, the inclusion time is of 2 years and the follow-up is of 5 years.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •age between 18 and 80 years;
- •life expectancy of greater than 10 years;
- •prostate adenocarcinoma histologically proven;
- •prostate cancer has to be of intermediate-risk based on at least one of the three following criteria: PSA between 10 ng/ml and 20 ng/ml, and/or a Gleason score of 7 and/or a T2B. Karnofsky performance status ≥ 60% and consequently performance status ECOG 0-
- •the patient has to be the beneficiary of the social security system (order n° 2006-477 from April 26th 2006);
- •the signed consent form.
排除标准
- •PSA level > 20;
- •Gleason > 7;
- •clinical T3A or T3B or MRI (a simple suspicion/ doubt on the MRI regarding the T3A won't be an exclusion criterion);
- •prostate volume > 60 cc;
- •pelvic lymph nodes involvement at dissection or imaging (ADP > 1.5 cm);
- •concurrent hormone therapy;
- •the presence of distant metastasis (M1);
- •history of abdominal or pelvic irradiation;
- •history of prostate resection in the previous 6 months and/or not allowing the implantation of markers;
- •history of uncontrolled cancer and/or treated since less than 5 years (excepting the basal-cell carcinoma);
- •urinary discomfort with an IPSS (International Prostate Symptom Score) > 15 (without alpha-blocking);
- •inflammatory bowel disorder such as ulcerative colitis or the Crohn's disease;
- •other undergoing study that may interfere with the present study;
- •patient under legal protection measure.
结局指标
主要结局
Comparison of the biochemical relapse free survival of the patients in two groups at 5 years for an external beam radiotherapy with a brachytherapy boost versus an exclusive external beam radiotherapy
时间窗: 5 years
Biochemical relapse is defined using the Phoenix definition of nadir of Prostate Specific Antigen + 2 ng/ml. This will be studied for both arms
次要结局
- The evaluation of the overall survival at 5 years.(5 years)
- The evaluation of the specific survival at 5 years(5 years)
- The evaluation of the survival without any metastatic evolution at 5 years(5 years)
- The study of all toxicities(5 years)
- Medical and economical evaluation.(5 years)
研究者
研究点 (58)
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