NCT02510378Unknown2 期
Short Course Radiotherapy Combined With Chemotherapy in Stage IV Rectal Cancer With Resectable Liver Metastases
适应症
试验速览
- 阶段
- 2 期
- 入组人数
- 47
- 试验地点
- 3
- 主要终点
- percentage of patients undergo R0 surgery during the follow-up
研究概览
简要总结
Patients with rectal cancer and resectable liver metastases receive short course radiotherapy(5Gy/f x 5f) to the pelvis and XELOX consolidating chemotherapy al least 4 cycles after 2 weeks.
详细描述
Patients with rectal cancer and resectable liver metastases receive 25 Gy in 5 fractions of 5 Gy over 5 days to the pelvis and XELOX consolidating chemotherapy (with or without target therapy) al least 4 cycles after 2 weeks.
After evaluation, patients with resectable rectal cancer and liver metastasis will undergo surgery. Those patients with unresectable lesions will receive chemotherapy.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed primary carcinoma of the rectum (Lower border of tumour ≤ 10 cm from anal verge) locally advanced stage in primary site of rectum resectable synchronous liver metastases. The decision of resectable liver metastases will be made at multidisciplinary clinical meetings.
排除标准
- •Obstruction of the gastrointestinal tract Previously constructed stoma prior radiotherapy of the pelvis
结局指标
主要结局
percentage of patients undergo R0 surgery during the follow-up
时间窗: 3 months
次要结局
- The rate of early toxicity of radiotherapy according to the NCI Common Toxicity Criteria for Adverse Effects (version 3.0)(3 months)
研究者
Hua Ren
Attending physician
Chinese Academy of Medical Sciences
研究点 (3)
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