A Phase II Study of Curative Proton Beam Therapy for Patients With Liver Metastasis of Colorectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- 2-year local control ratio of the treated liver area
研究概览
简要总结
Proton alone therapy is performed
-> 5 times a week, 7200 cGy / 15 fractions for 3 weeks total
详细描述
This clinical trial is a prospective, single-organ, phase II clinical trial to evaluate the efficacy of curative proton therapy for liver metastasis of colorectal cancer diagnosed histologically as adenocarcinoma. Patients who meet the selection criteria should be selected, signed for consent, and treated 5 times a week for 7200 cGy / 15 fractions alone for 3 weeks.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically diagnosed colon adenocarcinoma in primary or metastatic lesions..
- •If there is no other remote metastasis other than liver, or if there is, control is possible
- •If there are less than 2 liver metastatic lesions
- •If they refuse lung surgery or surgery is inappropriate (medically unsuitable for surgery due to surgery refusal, diabetes mellitus, high blood pressure, pulmonary disease, heart disease, etc., repeated surgery, poor systematic function, short disease-free period, etc.)
排除标准
- •Other histologic cancer other than adenocarcinoma of the colorectal
- •Colorectal cancer without primary lesion resection
- •If there is another remote metastasis and is not completely resected or regulated
- •If the patient has experience of other invasive cancer diagnosis within 5 years of colorectal cancer diagnosis
- •Pregnancy and women under lactation
研究组 & 干预措施
curative proton therapy
Patients who meet the selection criteria are selected, signed for consent, and treated with proton therapy alone at 7200 cGy / 15 fractions, 5 times a week for 3 weeks
干预措施: curative proton therapy (Radiation)
结局指标
主要结局
2-year local control ratio of the treated liver area
时间窗: Time Frame: up to 2 years
The primary goal of this study is the 2-year local control rate of liver lesions treated with proton therapy. It is judged that the local control rate is improved when the liver metastases of colorectal cancer using conventional X-ray is assumed to have 2-year local control rate of 60% and the 2-year local control rate of proton therapy is set to 80% or more
次要结局
- 5-year survival rate of treated patients(documented data of death, up to 5 years.)
- 5-year disease-free survival rate of treated patients(documented date of progression or death, up to 5 years)
研究者
DAE YONG KIM
Principal Investigator
National Cancer Center, Korea