Maintenance Treatment With Capecitabine Metronomic Chemotherapy and Chinese Traditional Medicine in Metastatic Colorectal Cancer
试验速览
- 阶段
- 4 期
- 入组人数
- 159
- 主要终点
- Progression-free survival
研究概览
简要总结
The optimum regimen of maintenance treatment after first-line chemotherapy in patients with metastatic colorectal cancer （mCRC） is unknown. This study was designed to determine the efficacy and safety of maintenance treatment with capecitabine metronomic chemotherapy plus Chinese Traditional Medicine.
In this Prospective, open-label, randomised controlled trial, the investigators will recruit 159 mCRC patients who have finished 18 to 24 weeks first-line chemotherapy and disease evaluation is SD, PR or CR. The patients will then accept Chinese traditional diagnosis and be randomised into two group, capecitabine metronomic chemotherapy only as control group and the metronomic chemotherapy plus Chinese Traditional Medicine as experimental group. This treatment regimen will be continued until progression, death, or an unacceptable adverse event.
The primary endpoint is progression-free survival (PFS). Secondary endpoints are overall survival (OS), quality of life (QOL) and toxic effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •unresectable metastatic colorectal cancer with pathological confirmation.
- •patients have accepted 18-24 weeks first-line chemotherapy and disease evaluation is SD, PR or CR.
排除标准
- 未提供
研究组 & 干预措施
Metronomic chemotherapy
Metronomic Chemotherapy for maintenance treatment with Capecitabine 300mg/m2 twice a day, everyday.
干预措施: Metronimic chemotherapy (Drug)
Metronimic chemotherapy plus Chinese Traditional Medicine
Metronomic Chemotherapy for maintenance treatment with Capecitabine 300mg/m2 twice a day, everyday.
Chinese Traditional Medicine
干预措施: Metronimic chemotherapy plus Chinese Traditional Medicine (Drug)
结局指标
主要结局
Progression-free survival
时间窗: six months
from randomising to progression, death, unacceptable AE
次要结局
未报告次要终点
研究者
Hao Li
associate chief physician, Department of Oncology
Ruijin Hospital