A Phase II Randomized Trial: ALTERNATE DAY ULTRAHYPOFRACTIONATED OR DAILY MODERATELY HYPOFRACTIONATED POST OPERATIVE RADIOTHERAPY
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 204
- 试验地点
- 2
- 主要终点
- Rates of Acute Toxicity
研究概览
简要总结
This is a multi-institution, randomized, non-inferiority Phase II trial comparing external beam radiotherapy delivered as 54 Gy in 20 fractions to prostate bed +/- 44 Gy in 20 fractions to pelvic lymph nodes delivered daily with external beam radiotherapy delivered as 30 Gy in 5 fractions to prostate bed +/- 25 Gy in 5 fractions to pelvic lymph nodes delivered on alternate days.
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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age >/= 18 years
- •Able to provide informed consent
- •Histologic diagnosis of prostate adenocarcinoma
- •ECOG performance status 0-1
- •Previous radical prostatectomy > 6 months prior to radiotherapy start date
- •Planned to receive post-operative radiation
排除标准
- •Prior pelvic radiotherapy
- •Contraindications to radiotherapy
- •Confirmed metastases (if scan has been done for clinical care)
- •Participants with visible disease in the prostate bed or pelvic lymph nodes on imaging are not eligible for treatment on study.
研究组 & 干预措施
Arm 1: Moderately Hypofractionated Radiotherapy
External beam radiotherapy 54 Gy in 20 fractions to prostate bed +/- 44 Gy in 20 fractions to pelvic lymph nodes delivered daily.
干预措施: Radiotherapy (Radiation)
Arm 2: Ultrahypofractionated Radiotherapy
External beam radiotherapy 30 Gy in 5 fractions to prostate bed +/- 25 Gy in 5 fractions to pelvic lymph nodes delivered on alternate days.
干预措施: Radiotherapy (Radiation)
结局指标
主要结局
Rates of Acute Toxicity
时间窗: 2 years
Acute grade ≥2 gastrointestinal toxicity (CTCAE v5.0)
次要结局
- Biochemical disease-free survival(2 years)
- Disease Control Rate(2 years)
- Rates of Acute and Late Toxicity(2 years)
- Quality of Life Outcomes(2 years)