Adjuvant Treatment of Fully Resected Stage III Colon Cancer With FOLFOX-4 Versus FOLFOX-4 Plus Cetuximab
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2,559
- 试验地点
- 8
- 主要终点
- Disease-free survival
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin, or fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving combination chemotherapy with or without cetuximab after surgery may kill any remaining tumor cells and keep colon cancer from coming back. It is not yet known whether giving combination chemotherapy together with cetuximab is more effective than giving combination chemotherapy alone in treating colon cancer.
PURPOSE: This randomized phase III trial is studying combination chemotherapy and cetuximab to see how well they work compared to combination chemotherapy alone in treating patients with stage III colon cancer that was completely removed by surgery.
详细描述
OBJECTIVES:
Primary
- Compare the disease-free survival rates in patients with completely resected stage III colon cancer treated with adjuvant oxaliplatin, leucovorin calcium, and fluorouracil with vs without cetuximab.
Secondary
- Compare the 3-year disease-free survival rate and 5-year overall survival rate in patients treated with these regimens.
- Compare the overall survival of patients treated with these regimens.
- Compare the treatment compliance of patients treated with these regimens.
- Determine the prognostic factors and markers predictive for relapse and/or treatment efficacy in patients treated with these regimens.
- Compare the safety of these regimens in these patients.
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 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Folfox+Cetuximab
FOLFOX-4 Cetuximab alone every 2 weeks
干预措施: Folfox (Drug)
Folfox+Cetuximab
FOLFOX-4 Cetuximab alone every 2 weeks
干预措施: Cetuximab (Drug)
Folfox
FOLFOX-4 alone every 2 weeks
干预措施: Folfox (Drug)
结局指标
主要结局
Disease-free survival
时间窗: 3-years DFS
DFS time in the ITT KRAS wild-type population
次要结局
- Overall survival(5 years)