NCT04724577Unknown不适用
Phase I Study on Carbon Ion Radiotherapy in 12 Fractions for Localized Prostate Cancer
Shanghai Proton and Heavy Ion Center1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Acute toxicity
研究概览
简要总结
The arm of this study is to explore the optimal dose of 12 fractions of carbon ion radiotherapy for prostate cancer in our center.
详细描述
The radiation dose of 51.6GyE in 12 fractions is currently widely used in Japan, and clinical studies of 51.6GyE/12Fx have also been carried out for SBRT. There are some differences in equipment and carbon ion treatment planning system used between Japan and our center. Therefore, we designed this phase I clinical study to explore the optimal dose of 12 fractions of carbon ion radiotherapy for prostate cancer.
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
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed adenocarcinoma of prostate
- •Stage cT1-3N0M0 localized prostate cancer
- •No lymph nodes or distant metastasis
- •Age ≥ 45 and < 85 years of age
- •Karnofsky Performance Score ≥70
- •No previous pelvic radiation therapy (RT)
- •No previous prostatectomy
- •No previous invasive cancer (within 5 years before the prostate cancer diagnosis)
- •Ability to understand character and individual consequences of the clinical trial
- •Willing to sign the written informed consent; Informed consent must be signed before the enrollment in the trial
排除标准
- •No pathologically confirmed adenocarcinoma of the prostate
- •Pelvic lymph node metastasis (N1)
- •Distant metastasis (M1)
- •Previous pelvic radiotherapy
- •Previous prostatectomy
结局指标
主要结局
Acute toxicity
时间窗: 3 months after the completion of CIRT
Treatment related acute toxicity assessed by CTCAE v4.03
次要结局
- Biochemical failure free survival,bFFS(From the complation of CIRT,a median of 5 years)
- Overall survival(From the diagnosis of prostate cancer,a median of 5 years)
- Progression free survival(From the complation of CIRT,a median of 5 years)
研究者
Ping Li
Principal Investigator
Shanghai Proton and Heavy Ion Center
研究点 (1)
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