Multimodal Therapy With and Without Cetuximab in Patients With Locally Advanced Esophageal Carcinoma - An Open-Label Phase III Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 297
- 试验地点
- 57
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays and to kill tumor cells. Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 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. It is not yet known whether giving radiation therapy together with chemotherapy is more effective with or without cetuximab in treating patients with esophageal cancer.
PURPOSE: This randomized phase III trial is studying giving radiation therapy together with chemotherapy, with or without cetuximab, followed by surgery in treating patients with locally advanced esophageal cancer that can be removed by surgery.
详细描述
OBJECTIVES:
Primary
- To determine the efficacy of neoadjuvant radiochemotherapy comprising docetaxel, cisplatin, and radiotherapy in combination with cetuximab followed by surgery and adjuvant cetuximab versus neoadjuvant radiochemotherapy comprising docetaxel, cisplatin, and radiotherapy followed by surgery in patients with locally advanced esophageal carcinoma.
Secondary
- To compare the toxicity of the two therapy arms.
- To determine patterns of failure overall and with regard to histology.
- To evaluate economic aspects in a subproject and to perform a radiotherapy quality assurance program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Additional immunotherapy (cetuximab)
All patients in the experimental arm will be given additional immunotherapy (cetuximab) during cycles 1 and 2, during RT and after surgery.
干预措施: cetuximab (Biological)
Additional immunotherapy (cetuximab)
All patients in the experimental arm will be given additional immunotherapy (cetuximab) during cycles 1 and 2, during RT and after surgery.
干预措施: cisplatin (Drug)
Additional immunotherapy (cetuximab)
All patients in the experimental arm will be given additional immunotherapy (cetuximab) during cycles 1 and 2, during RT and after surgery.
干预措施: docetaxel (Drug)
Additional immunotherapy (cetuximab)
All patients in the experimental arm will be given additional immunotherapy (cetuximab) during cycles 1 and 2, during RT and after surgery.
干预措施: adjuvant therapy (Procedure)
Additional immunotherapy (cetuximab)
All patients in the experimental arm will be given additional immunotherapy (cetuximab) during cycles 1 and 2, during RT and after surgery.
干预措施: neoadjuvant therapy (Procedure)
Without additional immunotherapy
Standard therapy without immunotherapy (cetuximab).
干预措施: cisplatin (Drug)
Without additional immunotherapy
Standard therapy without immunotherapy (cetuximab).
干预措施: docetaxel (Drug)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: time from randomization to a defined event.
time from randomization to one of the following events, whichever comes first: * Tumor progression at any time (progression of primary tumor or local lymph nodes, appearance of new lesions) * Recurrence at local, regional or distant site after surgery * Death from any cause
次要结局
- Time to locoregional failure after R0 resection(from date of surgery to date of first documented loco-regional failure)
- Progression-free survival after surgery(from date of surgery to an event as defined in PFS.)
- Adverse events according to CTCAE version 4.0 and major postoperative complications(during treatment and follow-up period.)
- Pathological remission(Assessed according to the tumor regression model of Mandard)
- Overall survival(time from trial randomization to the date of death from any cause)
- Time to systemic failure after R0 resection(from date of surgery to date of first documented systemic failure)
- In-hospital mortality(occurring after surgery but while the patient remains in hospital)
- Time to progression (TTP)(Time to progression is defined as time from randomization to one of the following events, whichever comes first: - Tumor progression at any time. - Recurrence at local, regional or distant site after surgery. - Death due to tumor)