NCT00693238已完成不适用
A Phase II Study of Hypofractionated Image Guided Proton Radiation Therapy for Low and Intermediate Risk Adenocarcinoma of the Prostate
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 228
- 试验地点
- 1
- 主要终点
- Acute Grade 3 (NCI CTC v4.0) or Higher Treatment-related Toxicity Rate.
研究概览
简要总结
The purpose of this trial is to give a shorter course (5 ½ weeks) of radiation that has as little side effects on normal bladder and rectal tissues as the usual longer course (8 weeks) of radiation, without decreasing the chance of killing prostate cancer cells.
详细描述
Low Risk - Total of 70 Gy/CGE over 28 treatments
Intermediate Risk - Total of 72.5 Gy/CGE over 29 treatments
研究设计
- 研究类型
- 干预性
- 分配方式
- 非随机
- 干预模型
- 平行分组
- 主要目的
- 治疗
- 盲法
- 开放（无盲法）
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 2-7.
- PSA ≤ 20 ng/ml.
排除标准
- Previous prostate cancer surgery or pelvic radiation.
- Prior or current chemotherapy for prostate cancer.
- Active inflammatory bowel disease (Crohn's disease, diverticulitis or ulcerative colitis) affecting the rectum.
- History of proximal urethral stricture requiring dilatation.
- History of hip replacement.
- Diabetes requiring medication.
- Prior intrapelvic surgery.
- Current and continuing anticoagulation with Warfarin sodium (Coumadin), Clopidogrel bisulfate (Plavix), enoxaparin sodium (Lovenox), or aspirin/er dipyridamole (Aggrenox).
- On Flomax (Tamsulosin), Hytrin (Terazosin) or Cardura (Doxazosin), Uroxatral (alfuzosin HCl).
- Taking Saw Palmetto or methotrexate and unable or unwilling to discontinue its use during radiation.
研究组 & 干预措施
Low Risk Proton Radiation
Experimental
70 Gy/CGE in 28 fractions of 2.5 Gy/CGE/fx
干预措施: Low Risk Proton Radiation (Radiation)
Intermediate Risk Proton Radiation
Experimental
72.5 GY/CGE in 29 fractions of 2.5 Gy/CGE/fx
干预措施: Intermediate Risk Proton Radiation (Radiation)
结局指标
主要结局
Acute Grade 3 (NCI CTC v4.0) or Higher Treatment-related Toxicity Rate.
时间窗: 6 months after the end of radiation therapy
次要结局
- Disease Control(20 years after end of radiation)
研究者
研究点 (1)
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标识符
- NCT 编号
- NCT00693238
- 其他研究编号
- UFPTI 0702-PR04, IRB201701653, UFJ 2008-022
日期
- 首次提交
- (18年前)
- 首次发布
- (18年前)
- 主要完成日期
- (14年前)
- 研究完成日期
- (4年前)
- 最近核实
- (3年前)
- 最近更新
- (3年前)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 是否有结果
- 是
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