NCT00233636撤回2 期
A 2 Part Phase 2 Trial to Evaluate ZD1839 (Iressa™) & Radiotherapy in Patients w/Locally Advanced Inoperable Squamous Cell Carcinoma of the Head & Neck
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- AstraZeneca
- 入组人数
- 28
- 试验地点
- 6
- 主要终点
- Tumour Response Rate, as complete response (CR) and partial response (PR) . Six months after Last Patient In.
研究概览
简要总结
The aim of the study is to determine if Iressa added to radiotherapy is effective and safe in shrinking tumour dimensions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically Confirmed locally advanced Squamous Cell Carcinoma of Head and neck
- •At least one measurable tumour lesion
排除标准
- •No previous treatment such as chemotherapy, radiotherapy and/or surgery for Carcinoma Head and Neck
- •No other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
- •Any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease)
结局指标
主要结局
Tumour Response Rate, as complete response (CR) and partial response (PR) . Six months after Last Patient In.
次要结局
- Time to progression, Overall survival, Duration of response. Six months after Last Patient In.
研究者
研究点 (6)
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