Randomized Trial Comparing Intensity Modulated Radiotherapy Versus Conformal Radiotherapy to Treat Prostate Cancer With Hypofractionated Schedule.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Gastrointestinal and geniturinary acute toxicity
研究概览
简要总结
There is no randomized controlled trial (RCT) comparing Conformal Radiotherapy (3DCRT) versus the Intensity Modulated Radiotherapy (IMRT) in terms of toxicity and disease control. Data from retrospective studies show that IMRT reduces the risk of severe late complications. More recently, the results from the RTOG 0126 study have also confirmed the benefit from IMRT in reducing acute toxicity for prostate cancer treated with conventional dose escalation. Therefore, to investigate the real clinical benefit of the IMRT over 3DCRT using a hypofractionated schedule in prostate cancer, the investigators developed a RCT.
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 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients with diagnosis of prostate cancer
- •With age between 18-75 years classified in low
- •Intermediate and high-risk group according to their Gleason score
- •T stage and initial PSA (iPSA).
- •Low risk group included patients with Gleason score <7 / stage T1-T2a, and iPSA <10 ng/mL.
- •Intermediate risk included Gleason score < 7, or Stage T1-T2b, or iPSA level of 10-20 ng/mL
- •High-risk patients with Gleason score >7, or Stage > T2b, or iPSA >20 ng/mL.
- •All patients classified as high risk was submitted to the bone scans.
排除标准
- •Patients with metastases
- •Prior history of prostatectomy
- •Pelvic radiotherapy treatment
- •Chemotherapy treatment were excluded of this trial.
结局指标
主要结局
Gastrointestinal and geniturinary acute toxicity
时间窗: 6 months
The primary study outcome was acute treatment reactions from the beginning of treatment to 6 months after the end of treatment. Patients were seen weekly, or as required, during treatment by a radiation oncologist. Acute gastrointestinal (GI) and genitourinary (GU) toxicity were prospectively assessed and graded according to the Radiation Therapy Oncology Group scoring system for the rectum and bladder.
Gastrointestinal and geniturinary late toxicity
时间窗: 24 months
Any toxicity developed after 6 months from radiotherapy treatment was considered as late toxicity. Late gastrointestinal (GI) and genitourinary (GU) toxicity were prospectively assessed and graded according to the Radiation Therapy Oncology Group scoring system for the rectum and bladder.
次要结局
- Biochemical control(3 years)
研究者
Gustavo Viani Arruda
Gustavo Arruda Viani, M.D, Phd.
Marilia Medicine School