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临床试验/NCT03285815
NCT03285815招募中不适用

A Phase II Randomized Trial of Hypofractionated Proton Therapy in Patients With a Localized Prostate Adenocarcinoma

National Cancer Center, Korea2 个研究点 分布在 2 个国家目标入组 156 人开始时间: 2016年5月最近更新:
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适应症

试验速览

阶段
不适用
状态
招募中
入组人数
156
试验地点
2
主要终点
BCFFS
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

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)

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

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Kwan Ho Cho

Principal Investigator

National Cancer Center, Korea

研究点 (2)

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