Randomized Study Comparing Induction Chemotherapy With Docetaxel, Cisplatin, 5FU Versus Cisplatin, 5 FU in Patients With T3 and T4 Larynx and Hypopharynx Carcinoma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- 3-years larynx preservation rate
研究概览
简要总结
The purpose of the study is to compare two regimen of chemotherapy used as first treatment for patients with larynx or hypopharynx tumors that would be treated with total laryngectomy. The standard treatment is a combination of 2 drugs (Cisplatin and 5FU). The aim of the study is to evaluate the potential benefit of the addition of a third drug (Docetaxel) in the chemotherapy regimen. Patients will receive 3 cycles of chemotherapy. Responders to the induction treatment are treated with radiation with a purpose of larynx preservation. Non responders patients will be treated with total laryngectomy.
详细描述
The purpose of the study is to compare two regimen of induction chemotherapy for patients with T3 and T4 larynx or hypopharynx carcinoma that would be treated with total laryngectomy. The aim of the study is to compare the standard regimen (Cisplatin + 5FU) versus the TPF regimen (Taxotere + Cisplatin + 5FU). Responders to the induction treatment are treated with radiation with a purpose of larynx preservation. Non responders patients will be treated with total laryngectomy followed by postoperative radiation.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •T3 and T4 larynx and hypopharynx tumor that would be treated with total laryngectomy
- •Biopsy proven carcinoma
- •Adequate biology
- •Performance status 0 or 1
排除标准
- •Larynx or hypopharynx tumors that could be treated with partial laryngectomy
- •Distant metastasis
- •Prior surgery, chemotherapy or radiation
- •Intercurrent disease that is a contra indication to chemotherapy
研究组 & 干预措施
TPF
Docetaxel, Cisplatine, 5-FU
干预措施: DOCETAXEL (Drug)
TPF
Docetaxel, Cisplatine, 5-FU
干预措施: Cisplatin (Drug)
TPF
Docetaxel, Cisplatine, 5-FU
干预措施: 5-Fluoro-3-Pyridinecarboxylic Acid (Drug)
PF
Cisplatine, 5-FU
干预措施: Cisplatin (Drug)
PF
Cisplatine, 5-FU
干预措施: 5-Fluoro-3-Pyridinecarboxylic Acid (Drug)
结局指标
主要结局
3-years larynx preservation rate
次要结局
- 5-years survival rate