NCT00539630已完成3 期
TAX + Cisplatin + 5 F/U vs Cisplatin + 5 F/U in SCCHN
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Clinical response will be evaluated by modified WHO criteria. Clinical and radiological assessment of all lesions will be performed
研究概览
简要总结
To describe the clinical response rate in two groups (Docetaxel plus cisplatin plus 5-FU, versus Cisplatin plus 5-FU) after 3 cycle of neoadjuvant chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically proven squamous cell carcinoma of the head and neck with locally advanced inoperable disease.
- •Primary tumor sites eligible: oral cavity, oropharynx, hypopharynx , larynx or nasopharynx.
- •Patients are required to have at least one (bi-or uni-dimensionally) measurable lesion.
- •WHO performance status 0 or
- •Adequate bone marrow, hepatic and renal functions.
排除标准
- •Pregnant and lactating women
- •Previous chemotherapy
- •Previous radiotherapy for H&N
- •Previous surgery for H&N
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
结局指标
主要结局
Clinical response will be evaluated by modified WHO criteria. Clinical and radiological assessment of all lesions will be performed
时间窗: After 2 cycle, 3 cycle and after concurrent chemo/radiotherapy.
次要结局
- Pathologic response if clinical response of primary tumor is CR at the end of chemotherapy and end of concurrent chemo/ radiotherapy, biopsy of primary tumor site will be performed to evaluate pathologic response rate.
研究者
研究点 (2)
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