NCT01709253已完成不适用
Phase 2 Hypofractionation Study Using Proton Beam Therapy for Prostate Adenocarcinoma
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
- 117
- 试验地点
- 1
- 主要终点
- clinical outcomes
研究概览
简要总结
Phase 2 hypofractionation study usion proton beam therapy for prostate adenocarcinoma
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
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Biopsy proven prostate adenocarcinoma Stage: T1-T2cN0M0 ECOG performance status: 0-2 Signed study specific informed consent prior to study entry
排除标准
- •Postoperative residual or recurrent tumor Evidence of distant metastases Previous irradiation for the tumor in the same location Adjuvant anti-androgenic hormonal therapy High risk group (NCCN guide line)
研究组 & 干预措施
Arm 1
Experimental
27pt/60CGE/20fx/5wks to PGTV(mon, tue, thu, fri; 4/wk)
干预措施: proton beam therapy (Radiation)
Arm 2
Experimental
27pt/54CGE/15fx/5wks to PGTV (mon, wed, fri; 3/wk)
干预措施: proton beam therapy (Radiation)
Arm 3
Experimental
27pt / 47CGE/10fx/5wk to PGTV(tue, thu;2/wk)
干预措施: proton beam therapy (Radiation)
Arm 4
Experimental
27pt/ 35CGE/ 5fx/2.5wk to PGTV(the, thu; 2/wk)
干预措施: proton beam therapy (Radiation)
结局指标
主要结局
clinical outcomes
时间窗: up to 5years from a initial follow-up
To evaluate biochemical failure-free survival (BCFFS)
次要结局
- acute toxicity(up to 5years from a initial follow-up)
- late toxicity(up to 5years from a initial follow-up)
- overall survival(up to 5years from a initial follow-up)
研究者
Kwan Ho Cho
M.D.
National Cancer Center, Korea
研究点 (1)
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