A Pilot Phase II Trial of Irinotecan Discontinuation and Reintroduction in Patients With Previously Untreated Advanced Colorectal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Response rate after FOLFIRI reintroduction
研究概览
简要总结
The purpose of this study is to evaluate the feasibility and efficacy of first-line FOLFIRI discontinuation after initial 8 cycles and reintroduction after progression.
详细描述
For medically-fit patients with advanced colorectal cancer, the current standard approach is chemotherapy with FOLFIRI or FOLFOX. Although a strategy of using sequential 5-FU, irinotecan and oxaliplatin has been thought to maximize overall survival in such patients, significant toxicity remains a problem. It has been suggested feasible that chemotherapy can be discontinued after 2-3 months and restart same treatment on progression in patients with chemosensitive colorectal cancer. Thus we designed this pilot phase II study to evaluate the feasibility and efficacy of first-line FOLFIRI discontinuation after initial 8 cycles and reintroduction after progression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proven adenocarcinoma of colon and rectum
- •No prior chemotherapy or only adjuvant chemotherapy and/or radiotherapy
- •Advanced, metastatic or recurrent not amenable to curative local therapy
- •Measurable lesion(s)
- •ECOG performance status 0 to 2
- •Normal marrow, hepatic and renal function
- •Provision of written informed consent
排除标准
- •Active infection and/or severe comorbidity
- •Known history of anaphylaxis of any origin
结局指标
主要结局
Response rate after FOLFIRI reintroduction
次要结局
- Progression-free survival
- Overall survival