NCT04456621已完成不适用
Proton Beam Radiotherapy for Unresectable Liver Metastasis: Prospective Phase II Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- 6 month local control rate
研究概览
简要总结
The investigators performed the present study to evaluate the role of proton beam therapy for liver metastasis which is unresectable and unsuitable for radiofrequency ablation (RFA) in terms of local control and safety.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pathologically diagnosed cancer patient
- •confirmed liver metastasis via computed tomography (CT) or magnetic resonance imaging (MRI) or biopsy
- •unresectable or unsuitable for RFA
- •solitary liver metastasis or less than 3 metastatic lesions if the distance is less than 3 cm between metastatic lesions
- •case discussed by surgeon, radiologist, and radiation oncologist
- •Eastern cooperative oncology group performance status 0 to 2
- •optimal liver and renal function (Child-Pugh score 10 or less)
- •informed consent
- •agree to be contraceptive for the duration of the study and for the next 6 months
排除标准
- •uncontrolled ascites or hepatorenal syndrome
- •status of pregnancy or breast-feeding
- •less than 12 weeks of expected survival
- •combined disease known to have high radiation side effects
- •serious acute illness that is not treated other than liver disease
结局指标
主要结局
6 month local control rate
时间窗: at the point of 6 month follow-up after proton beam therapy
local control rate (except local progression)
次要结局
- 6 month side effect(at the point of 6 month follow-up after proton beam therapy)
- Overall survival rate(at the point of 2 year follow-up after proton beam therapy)
研究者
Park Hee Chul
Professor
Samsung Medical Center
研究点 (2)
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