NCT00255476已完成2 期
A Randomised Phase II Study to Investigate the Feasibility and Benefits of Combining ZD1839 and Cisplatin/5FU, as Induction Therapy, in Patients With Locally and Advanced Squamous Cell Carcinoma of the Head and Neck
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- To compare the objective tumour response rate between cisplatin/5FU and cisplatin/5FU and ZD1839 combination in these patients
研究概览
简要总结
The purpose of this study is to compare the objectie tumour response rate between the cisplatin/5FU and cisplatin/5FU plus ZD1839 combination
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
- •Provision of written informed consent
- •Patients with histologically proven primary SCCHN
- •Aged 18 or over
排除标准
- •Patients eligible for surgery with curative intent
- •Other co-existing malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
- •Exclude UCNT
结局指标
主要结局
To compare the objective tumour response rate between cisplatin/5FU and cisplatin/5FU and ZD1839 combination in these patients
次要结局
- To compare safety and tolerability in these patients
研究者
研究点 (1)
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