NCT03285815Unknown不适用
A Phase II Randomized Trial of Hypofractionated Proton Therapy in Patients With a Localized Prostate Adenocarcinoma
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- BCFFS
研究概览
简要总结
A Phase II Randomized Trial of Hypofractionated Proton Therapy in Patients With A Localized Prostate Adenocarcinoma
详细描述
For Proton therapy with prostate adenocarcinoma patients.
Arm 1: Proton therapy 3CGE x 20days = Total 60 CGE for 4 weeks.
Arm 2: Proton therapy 4.7CGE x 10days = Total 47 CGE for 2 weeks.
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:0-1
- •Signed study specific informed consent prior to study entry.
排除标准
- •Postoperative residual or recurrent tumor
- •Evidence of distant metastasis 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
Proton Therapy 60 CGE
Experimental
60 CGE (3CGE X 20) for 4wks
干预措施: Proton Therapy (Device)
Proton Therapy 47 CGE
Experimental
47 CGE (4.7CGE X 10) for 2wks
干预措施: Proton Therapy (Device)
结局指标
主要结局
BCFFS
时间窗: up to 5 years from a initial follow-up
To evaluate biochemical failure-free survival (BCFFS)
次要结局
- EPIC (Extended Prostate Cancer Index Composite)(up to 5 years from a initial follow-up)
- Acute/late toxicity (CTCAE v4.0)(up to 5 years from a initial follow-up)
- Disease specific survival(up to 5 years from a initial follow-up)
研究者
Kwan Ho Cho
Principal Investigator
National Cancer Center, Korea
研究点 (1)
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