Randomized Phase II Trial of Neoadjuvant Docetaxel Plus Cisplatin and 5-fluorouracil Followed by Concomitant Chemoradiotherapy and Chemoradiotherapy Alone in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- Rate of radiologic Complete Response (CR) evaluated 6-8 weeks after the completion of treatment
研究概览
简要总结
To evaluate the rate of clinical complete response 6-8 weeks after treatment with docetaxel plus cisplatin and 5-fluorouracil followed by chemoradiotherapy and after chemoradiotherapy alone in patients with locally advanced squamous cell carcinoma of the head and neck.
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
A
Cisplatin from day 1 to day 4 and 5-FU for 4 days starting immediately after the end of cisplatin infusion on day 1. Both drugs were administered during week 1 and 6 of irradiation, starting from day 1 of weekly radiotherapy.
干预措施: Concomitant cisplatin, 5-FU and radiotherapy (Drug)
B
Docetaxel followed by cisplatin and 5-FU from day 1 to day 4 starting after the end of cisplatin infusion. The cycle was repeated every 3 weeks up to a total of 3 cycles. After 3-6 weeks from the end of neoadjuvant chemotherapy, patients will receive with the same modality of arm A (reference arm).
干预措施: Docetaxel, cisplatin and 5-FU treatment followed by concomitant cisplatin, 5-FU and radiotherapy (Drug)
结局指标
主要结局
Rate of radiologic Complete Response (CR) evaluated 6-8 weeks after the completion of treatment
时间窗: from end of treatment until 6-8 weeks
次要结局
- Time to disease progression(From the date of the treatment start to the date of first documented progression of disease)
- Duration of response(from the date of first documented tumor response to the date of first documented tumor progression)
- Time to treatment failure(from the date of treatment start to the date of diagnosis of progression, withdrawal from study treatment for any reason, administration of other antitumor treatment, or death for any cause)
- Median length of overall survival(time interval from the date of treatment to the date of death)