A Multicenter, Randomized Phase II Study of Weekly XELIRI Regimen Versus FOLFIRI in the Treatment of Advanced Colorectal Cancer Patients
试验速览
- 阶段
- 2 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Progression free survival which is calculated from the start of treatment to disease progression or death
研究概览
简要总结
The aim of this study is to compare weekly-XELIRI(wXELIRI) regimen versus FOLFIRI regimen in the treatment of advanced colorectal cancer patients. The hypothesis is the efficacy of wXELIRI is not less than FOLFIRI with tolerable toxicity.
详细描述
The combination of irinotecan and fluorouracil drugs regimen is frequently used in patients with advanced colorectal cancer. According to the previous data, higher rate of diarrhea was observed in the combination of irinotecan and capecitabine (XELIRI) regimen, compared to the combination of irinotecan and 5-fluorouracil (FOLFIRI) regimen. However, the modified weekly XELIRI regimen, which was investigated in our previous single armed study, show tolerate toxicities compared with FOLFIRI, without compromising efficacy. It is supposed that wXELIRI regimen is no less less than FOLFIRI regimen in efficacy.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Second-line treatment for advanced colorectal cancer,irinotecan was not previously used.
- •Age range 18-70 years old
- •ECOG performance status 0-1
- •Life expectancy of more than 3 months
- •Adequate organ function
排除标准
- •Previous serious cardiac disease
- •History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
- •Pregnant or lactating women
- •chronic inflammatory bowel disease or intestinal obstruction
- •Serious uncontrolled diseases and intercurrent infection
研究组 & 干预措施
FOLFIRI
FOLFIRI regimen
干预措施: FOLFIRI regimen (Drug)
wXELIRI regimen
wXELIRI
干预措施: wXELIRI regimen (Drug)
结局指标
主要结局
Progression free survival which is calculated from the start of treatment to disease progression or death
时间窗: eight weeks
次要结局
- Objective response rate which includes complete response(CR) and partial response(PR) participants(eight weeks)