Induction Chemotherapy With Cetuximab, Docetaxel, Cisplatin, and Fluorouracil (ETPF) in Patient With Resectable Stage III-IV Squamous Cell Carcinoma of the Oropharynx
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 8
- 主要终点
- Clinical and Radiological Complete Clinical Response (crCR) Rate at 3 Months
研究概览
简要总结
RATIONALE: 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. Drugs used in chemotherapy, such as docetaxel, cisplatin, and 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) together with cetuximab may kill more tumor cells.
PURPOSE: This phase II clinical trial is studying how well cetuximab given together with combination chemotherapy works in treating patients with stage III or stage IV oropharynx cancer that can be removed by surgery.
详细描述
OBJECTIVES:
Primary
- To determine the complete clinical response rate at 3 months in patients with stage III or IV nonmetastatic squamous cell carcinoma of the oropharynx treated with cetuximab, docetaxel, cisplatin, and fluorouracil.
Secondary
- To determine the rate of tumor response.
- To determine progression-free and overall survival.
- To determine the rate of complete pathological response.
- To assess the tolerability of this regimen in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
cetuximab
Cetuximab by intravenous (IV) infusion over 1-2 h on day
干预措施: cisplatin (Drug)
cetuximab
Cetuximab by intravenous (IV) infusion over 1-2 h on day
干预措施: docetaxel (Drug)
cetuximab
Cetuximab by intravenous (IV) infusion over 1-2 h on day
干预措施: fluorouracil (Drug)
cetuximab
Cetuximab by intravenous (IV) infusion over 1-2 h on day
干预措施: Cetuximab (Drug)
结局指标
主要结局
Clinical and Radiological Complete Clinical Response (crCR) Rate at 3 Months
时间窗: at 3 months after ETPF combination
The evaluation of tumor response rate was assessed by computed tomography scan of the neck and chest at Baseline, then at 3 months from inclusion using RECIST1.0 criteria and clinical examination
次要结局
- The 2-year Estimated Progression-free Survival (PFS)(2 years)
- Complete Radiological Response (rCR)(At 3 months after the end of 3 cycles of the ETPF combination)
- The 2-year Estimated Overall Survival (OS) Rate(2 years)
- Complete Clinical Response (cCR)(at 3 months)
- Pathologic Response(after surgery of the primary tumor)