An Open-label, Randomized, Parallel-group, Multicenter Study of Neoadjuvant Docetaxel(Taxotere®) Plus Cisplatin Plus 5-fluorouracil Versus Neoadjuvant Cisplatin Plus 5-fluorouracil in Patients With Locally Advanced Inoperable Squamous Cell Carcinoma of the Head and Neck
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
The Primary Objective is to evaluate the progression-free survival after treatment with docetaxel plus cisplatin plus 5-Fluorouracil (5-FU) (DCF) in comparison with cisplatin plus 5-FU (CF) in patient with locally advanced inoperable SCCHN The Secondary Objective is to evaluate and compare the clinical response rate both before and after radiotherapy, the local symptoms, the duration of response, the time to treatment failure, the survival, the toxicity and the quality of life in the 2 study groups.
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 70 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
Docetaxel Cisplatin 5-Fluorouracil (DCF)
4 cycles of the following products every 3 weeks (unless disease progression/relapse or unacceptable toxicity occured or the patient refused treatment):
- Docetaxel 60mg/m² on day 1
- Cisplatin 75mg/m² on day 1
- 5-FU 750mg/m²/day on day 1 to day 5
干预措施: DOCETAXEL (Drug)
Docetaxel Cisplatin 5-Fluorouracil (DCF)
4 cycles of the following products every 3 weeks (unless disease progression/relapse or unacceptable toxicity occured or the patient refused treatment):
- Docetaxel 60mg/m² on day 1
- Cisplatin 75mg/m² on day 1
- 5-FU 750mg/m²/day on day 1 to day 5
干预措施: CISPLATIN (Drug)
Docetaxel Cisplatin 5-Fluorouracil (DCF)
4 cycles of the following products every 3 weeks (unless disease progression/relapse or unacceptable toxicity occured or the patient refused treatment):
- Docetaxel 60mg/m² on day 1
- Cisplatin 75mg/m² on day 1
- 5-FU 750mg/m²/day on day 1 to day 5
干预措施: 5-FLUOROURACIL (Drug)
Cisplatin 5-Fluorouracil (CF)
4 cycles of the following products every 3 weeks (unless disease progression/relapse or unacceptable toxicity occured or the patient refused treatment):
- Cisplatin 75mg/m² on day 1
- 5-FU 750mg/m²/day on day 1 to day 5
干预措施: CISPLATIN (Drug)
Cisplatin 5-Fluorouracil (CF)
4 cycles of the following products every 3 weeks (unless disease progression/relapse or unacceptable toxicity occured or the patient refused treatment):
- Cisplatin 75mg/m² on day 1
- 5-FU 750mg/m²/day on day 1 to day 5
干预措施: 5-FLUOROURACIL (Drug)
结局指标
主要结局
Progression-free survival
时间窗: From randomization to any progression event or patient death (follow-up every 3 months 1st year, then every 6 months)
次要结局
- Overall survival(From randomization to patient death (follow-up every 3 months 1st year, then every 6 months))
- Overall response rates(From randomization to any progression event or patient death (follow-up every 3 months 1st year, then every 6 months) and at the end of chemotherapy + end of radiotherapy)
- Duration of response(From randomization to any progression event or patient death (follow-up every 3 months 1st year, then every 6 months))
- Time to treatment failure(From randomization to any progression event or patient death (follow-up every 3 months 1st year, then every 6 months) and at the end of chemotherapy + end of radiotherapy)