NCT01368055已完成不适用
An Expanded Phase II Study of Hypofractionated Dose Intense Image Guided Proton Radiation Therapy for Low and Intermediate Risk Adenocarcinoma of the Prostate
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 361
- 试验地点
- 2
- 主要终点
- Cumulative incidence of treatment-related grade 2 or higher rectal bleeding.
研究概览
简要总结
The purpose of this trial is to give a shorter course (5 ½-6 weeks) of proton radiation that has as little side effects on normal bladder and rectal tissues as the usual longer course (8 weeks) of proton radiation, without decreasing the chance of killing prostate cancer cells.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Prostate cancer.
- •Gleason score 2-6 or
- •PSA ≤ 20 ng/ml.
排除标准
- •Previous prostate cancer surgery or pelvic radiation.
- •Prior/concurrent systemic chemotherapy for prostate cancer.
- •Active inflammatory bowel disease (Crohn's disease, diverticulitis or ulcerative colitis) affecting the rectum.
- •History of hip replacement.
- •Prior intrapelvic surgery.
- •Taking Saw Palmetto or methotrexate and unable or unwilling to discontinue its uses during radiation.
- •Receiving continuous and current anticoagulation with Warfarin sodium (Coumadin), Clopidogrel bisulfate (Plavix), dabigatran etexilate mesylate (Pradaxa),enoxaparin sodium (Lovenox), or aspirin/er dipyridamole (Aggrenox).
结局指标
主要结局
Cumulative incidence of treatment-related grade 2 or higher rectal bleeding.
时间窗: 2 years after completion of radiation therapy
次要结局
- Analyzation of quality of life(After radiation: every 6 months for 3 years, then annually for 20 years)
- Analysis of treatment-related morbidity(Cumulative incidence up to 20 years after completion of radiation therapy)
- Analysis of disease control(Cumulative incidence up to 20 years after completion of radiation therapy)
- Analysis of overall survival(Cumulative incidence up to 20 years after completion of radiation therapy)
研究者
研究点 (2)
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