Early Evaluation of Chemosensitivity for Low-risk Stage II/III Rectal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- tumor volume
研究概览
简要总结
Chemosensitivity of rectal cancer is not discussed clearly. With previous study, the investigators design this phase II trial to explore the effect of 2 cycles Xelox chemotherapy,so as to explore the early detection of sensitivity of tumor. With inclusion of early,intermediate,and bad stage II/III rectal cancer patients, four cycle of Xelox chemotherapy was given. After the second cycle, MRI,TRUS,DE,endoscopy,and blood DNA test was down to compare with these characteristics of four cycles.so that to detect the data about the chemosensitivity of tumor in the early stage.
详细描述
Chemosensitivity of rectal cancer is not discussed clearly. With previous study, the investigators design this phase II trial to explore the effect of 2 cycles Xelox chemotherapy,so as to explore the early detection of sensitivity of tumor. With inclusion of early,intermediate,and bad stage II/III rectal cancer patients, four cycle of Xelox chemotherapy was given. After the second cycle, MRI,TRUS,DE,endoscopy,and blood DNA test was down to compare with these characteristics of four cycles.so that to detect the data about the chemosensitivity of tumor in the early stage.In future, a phase III trial that explore the effect of radiation or surgery in these chemoresistant patients.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •.endoscopy and biopsy verified rectal cancer within 12cm from anal verge;
- •.primary MRI, TRUS, abdomino-chest CT diagnosed early or intermediate or bad Stage II/III rectal cancer;
- •.age from 20-75;
- •.with informed consent;
排除标准
- •.refuse the further treatment after recruiting;
- •.diagnosis of peritoneal metastasis in the surgery;
研究组 & 干预措施
chemotherapy group
patients receive 4 cycles of Xelox
干预措施: XELOX (Drug)
结局指标
主要结局
tumor volume
时间窗: At the end of Cycle 4 (each cycle is 3 weeks)
tumor volume measured by MRI
tumor area in endoscopy
时间窗: At the end of Cycle 4 (each cycle is 3 weeks)
tumor area measured in endoscopy
次要结局
- tumor thickness in TRUS(At the end of Cycle 2 (each cycle is 3 weeks))
- blood DNA test(At the end of Cycle 4 (each cycle is 3 weeks))
研究者
Ziqiang Wang,MD
professor
West China Hospital