NCT00261703已完成2 期
Randomized Phase III Trial Comparing Induction Chemotherapy With Cisplatin/5-fluorouracil (PF) or Docetaxel/Cisplatin/5-fluorouracil (TPF) Plus Chemoradiotherapy (CRT) Versus CRT Alone as First-line Treatment or Unresectable Locally Advanced Head and Neck Cancer (LAHNC).
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 439
- 试验地点
- 1
- 主要终点
- Phase II: Clinical objective response rate, at the end of inducted chemotherapy (groups A and B) and at the end of combined treatment (groups A, B and C).
研究概览
简要总结
Primary Objective:
- Phase II: To determine the best treatment scheme (TPF vs. PF).
- Phase III: To compare the time to progression and the treatment failure at the 3 arms.
Secondary objectives:
- To evaluate the safety at the 3 arms.
- To compare the progression , overall survival and locoregional control at the 3 arms.
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
- •Head and Neck cancer locally advanced (oral cavity, oropharynx, hypopharynx or larynx) but without evident metastasis.
- •Inoperable tumor after revision by a multidisciplinary oncology team.
- •Proved epidermoid carcinoma.
- •ECOG = 0-1
- •Good hematologic function (i.e, hemoglobin > 10 g/dl, ...)
- •Good hepatologic function
- •Good renal function
排除标准
- •Pregnant or breast-feeding women. Potential child-bearing women should use an effective conceptive method and should have a negative pregnancy test at least the week before entering the study.
- •Nasopharynx, nasal cavity and paranasal sinusitis will be excluded
- •Previous chemotherapeutic or radiotherapeutic treatment for this disease.
- •Previous or current neoplasms in other locations, except in situ cervicouterine cancer properly treated or basal cell or squamous cell carcinoma
- •Symptomatic peripheral neuropathy
- •Other clinical severe diseases
- •Concomitant treatment with corticoids within 6 months prior to inclusion.
- •Concomitant treatment with any other neoplastic therapy
- •Previous treatment for current disease.
- •Loss of weight greater than 10% within the last 3 months.
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
1
Experimental
(Docetaxel + Cisplatin + 5-FU) + Cisplatin + Radiotherapy
干预措施: Docetaxel, Cisplatin, 5-fluorouracil (5-FU), radiotherapy (Drug)
2
Experimental
(Cisplatin + 5-FU) + Cisplatin + Radiotherapy
干预措施: Cisplatin, 5-fluorouracil (5-FU), radiotherapy (Drug)
3
Experimental
Cisplatin + Radiotherapy
干预措施: Cisplatin + radiotherapy (Other)
结局指标
主要结局
Phase II: Clinical objective response rate, at the end of inducted chemotherapy (groups A and B) and at the end of combined treatment (groups A, B and C).
时间窗: 16 weeks
Phase III: Surveillance with no progression after two years.
时间窗: 2 years
次要结局
未报告次要终点
研究者
研究点 (1)
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