NCT00286000已完成2 期
High Dose Simplified Folfiri in Advanced Colorectal Cancer: a Multicentre Phase II Study
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- Response rate
研究概览
简要总结
A multicentre phase II study to evaluate the results of high dose simplified folfiri in advanced colorectal cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically proven adenocarcinoma of the colon or rectum
- •Documented progressive metastatic disease
- •Patients who have at least one uni-dimensional measurable lesion by CT-scan or MRI according to response evaluation criteria in solid tumours (RECIST)
- •WHO performance status of 0 or 1
- •Adequate laboratory values of haematology, liverfunction and renal function
- •No previous chemotherapy for metastatic colorectal cancer
排除标准
- •Past or concurrent history of neoplasm other than colorectal adenocarcinoma, except curatively treated cancer free of disease for more than 10 years.
- •Bowel obstruction or sub-obstruction. Crohn's disease, or ulcerative colitis.
- •Other severe illness or medical condition such as unstable cardiac disease under treatment, myocardial infarction within 6 months before inclusion.
- •Active uncontrolled infection
- •Other concomitant anticancer agent
结局指标
主要结局
Response rate
次要结局
- Resectability
- Safety
- TTP
研究者
研究点 (2)
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