NCT01417676已完成不适用
Pelvic Lymph Node Irradiation With Simultaneous Integrated Boost to Prostate for High Risk Prostate Cancer Patients: A Phase I/II Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 87
- 试验地点
- 2
- 主要终点
- Incidence of late gastro-intestinal toxicity ≥ grade 2.
研究概览
简要总结
This is a prospective, open label 1 arm study, multicentre, Phase I/II clinical safety study. The trial is designed to gain initial safety and efficacy data on pelvic lymph node radiation with simultaneous integrated boost to prostate in high risk prostate cancer patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •adenocarcinoma
- •T3 tumor and either Gleason 8-10 and PSA ≤ 70,or PSA ≥ 30 and PSA ≤ 70, or T1-T3 and PSA ≤ 70 and N1
- •no distant metastases
排除标准
- •pelvic co-morbidity such as Crohns disease or ulcerative colitis
- •uncontrolled heart or lung morbidity
- •prior radiation treatment of pelvic region
- •age > 75 years
结局指标
主要结局
Incidence of late gastro-intestinal toxicity ≥ grade 2.
时间窗: 3 years and beyond
based on CTCAE v.4.0 og in-house questionnaire.
次要结局
- Incidence of late genito-urinary toxicity ≥ grade 2.(3 years and beyond)
- recurrence(10 years)
- survival(10 years)
研究者
研究点 (2)
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