A Randomised Phase II/III Multi-Centre Clinical Trial of Definitive Chemotherapy, With or Without Cetuximab, in Carcinoma of the Oesophagus
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 259
- 试验地点
- 55
- 主要终点
- Treatment-failure rate at 24 weeks
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as cisplatin and capecitabine, work in different ways to kill tumor cells or stop them from growing. Radiation therapy uses high-energy x-rays to kill 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. It is not yet known whether giving cisplatin together with capecitabine and radiation therapy is more effective with or without cetuximab in treating esophageal cancer.
PURPOSE: This randomized phase II/III trial is studying the side effects and how well giving cisplatin together with capecitabine, radiation therapy, and cetuximab works compared with giving cisplatin, capecitabine, and radiation therapy without cetuximab in treating patients with esophageal cancer.
详细描述
OBJECTIVES:
Primary
- To determine whether the addition of cetuximab to definitive chemoradiotherapy comprising cisplatin, capecitabine, and radiotherapy shows evidence of enhanced overall survival in patients with carcinoma of the esophagus.
- To determine the safety of this regimen in these patients.
- To determine the feasibility of this regimen in these patients.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive cisplatin IV over 2 hours on days 1, 22, 43, and 64 and oral capecitabine twice daily on days 1-84. Beginning in week 7 patients also undergo radiotherapy 5 days a week for 5 weeks (weeks 7-11). Treatment continues in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive cisplatin and capecitabine and undergo radiotherapy as in arm I. Patients also receive cetuximab IV over 1-2 hours on day 1 in weeks 1-12. Treatment continues in the absence of disease progression or unacceptable toxicity.
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 —（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
Chemo-radiotherapy
干预措施: capecitabine (Drug)
Chemo-radiotherapy
干预措施: cisplatin (Drug)
Chemo-radiotherapy
干预措施: radiation therapy (Radiation)
Chemo-radiotherapy plus cetuximab
干预措施: cetuximab (Biological)
Chemo-radiotherapy plus cetuximab
干预措施: capecitabine (Drug)
Chemo-radiotherapy plus cetuximab
干预措施: cisplatin (Drug)
Chemo-radiotherapy plus cetuximab
干预措施: radiation therapy (Radiation)
结局指标
主要结局
Treatment-failure rate at 24 weeks
Overall survival
次要结局
- Feasibility
- Toxicity
- Quality of life
- Quality of assurance
- Health economics