NCT02935023Unknown2 期
Carbon Ion Radiotherapy in Treating Patients Undergoing Systemic Therapy for Oligo-metastatic Prostate Cancer
Shanghai Proton and Heavy Ion Center1 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2016年9月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Time to PSA relapse
研究概览
简要总结
The goal of this clinical study is to determine impact of carbon ion radiotherapy (CIRT) treatment in combination with systemic therapy for oligo-metastatic prostate cancer. The primary objective: to determine disease biochemical progression-free survival in man with oligo-metastatic (M1a/b) prostate cancer undergoing systemic therapy with definitive radiotherapy of the primary tumor. The secondary objective: to determine local control, overall survival and quality of life in men with oligo-metastatic prostate cancer undergoing carbon ion radiotherapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed adenocarcinoma of the prostate
- •Age ≥ 20 and < 80 years of age
- •ECOG PS 0 or 1
- •Life-expectancy ≥1 year
- •Stage T1-4,N0-1,M1a/b disease on imaging, with a combined maximum of 3 synchronous lesions.
- •Ability to understand and willingness to sign informed consent
排除标准
- •No pathologically confirmed adenocarcinoma of the prostate
- •visceral metastasis
- •Previous pelvic radiotherapy or prostatectomy
- •Severe systemic disorders
结局指标
主要结局
Time to PSA relapse
时间窗: From the start of systemic therapy, a median of 2 years
次要结局
- progression free survival(From the start of systemic therapy, a median of 2 years)
- Quality of life(From the start of carbon ion radiotherapy, a median of 2 years)
- Overall survival(From the start of systemic therapy, a median of 2 years)
研究者
Shen Fu
Director,department of radiation oncology
Shanghai Proton and Heavy Ion Center
研究点 (1)
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