Induction by Docetaxel/Cisplatin/5-Fluorouracil (TCF) Prior to Radiotherapy With Concomintant Cetuximab in Locally Advanced Inoperable Head and Neck Tumours - a Methodical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 5
- 主要终点
- Locoregional tumour control
研究概览
简要总结
The purpose of the trial is to determine the feasibility of an induction chemotherapy with radio-immunotherapy in patients with head and neck cancer stage III/IV
详细描述
3 Cycles of: Docetaxel 75 mg/m2 on d1, Cisplatin 75 mg/m2 on d1, 5-FU 750 mg/m2 on days 1-5 as continuous i.v. infusion, Duration of 1 cycle: 21 days;
Followed by Cetuximab 400 mg/m2, Start of radiotherapy: 1 week after the first application of Cetuximab, During radiotherapy (35 x 2 Gy): Cetuximab 250 mg/m2 weekly, Up to 8 applications of Cetuximab.
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
- •histologically confirmed, locally advanced head and neck cancer
- •stage III/IV
- •performance status: ECOG 0-1
排除标准
- •distant metastases
- •prior radiotherapy of the head and neck region
- •myocardial infarct in the last six months
- •florid peptic ulcer
- •neuropathy grade III/IV
研究组 & 干预措施
Single Arm
3 cycles of induction chemotherapy consisting of docetaxel, cisplatin, and 5-FU followed by radiotherapy plus cetuximab
干预措施: Docetaxel (Drug)
Single Arm
3 cycles of induction chemotherapy consisting of docetaxel, cisplatin, and 5-FU followed by radiotherapy plus cetuximab
干预措施: Cisplatin (Drug)
Single Arm
3 cycles of induction chemotherapy consisting of docetaxel, cisplatin, and 5-FU followed by radiotherapy plus cetuximab
干预措施: 5-FU (Drug)
Single Arm
3 cycles of induction chemotherapy consisting of docetaxel, cisplatin, and 5-FU followed by radiotherapy plus cetuximab
干预措施: Radiotherapy (Radiation)
Single Arm
3 cycles of induction chemotherapy consisting of docetaxel, cisplatin, and 5-FU followed by radiotherapy plus cetuximab
干预措施: Cetuximab (Drug)
结局指标
主要结局
Locoregional tumour control
时间窗: 12 months
Time without progression of locoregional disease, locoregional recurrence of disease or death from any cause after one year.
次要结局
- Progression free survival(24 months)
- Overall survival(24 months)
- Toxicities(24 months)
- Response rate(24 months)