NCT00681967已完成1 期
Conventional Postoperative Radiotherapy (Standard Fractionation) Plus Iressa or Hyperfractionated Radiotherapy Plus Cisplatin and Iressa for Advanced Head & Neck Cancer: A Phase I Pilot Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To evaluate the feasibility and safety of (cohort 1) postoperative standard fractionation radiotherapy plus Iressa and of (cohort 2) hyperfractionated radiotherapy plus cisplatin and Iressa
研究概览
简要总结
To evaluate the feasibility and safety of (cohort 1) postoperative standard fractionation radiotherapy plus Iressa and of (cohort 2) hyperfractionated radiotherapy plus cisplatin and Iressa
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
- •Written informed consent
- •Age over 18 years
- •Histologically proven squamous cell cancer of the head & neck (SCCHN)
- •Indication for postoperative Radiotherapy: pT3, pT4, pN2b, pN2c, pN3
排除标准
- •Hypersensitivity to ZD1839 or any of the excipients of this product
- •Tumour stage M1
- •Co-existing malignancies diagnosed within the last 5 years. Exceptions: basal cell carcinoma, cervical cancer in situ
- •Absolute neutrophil counts <1.5 x 109
研究组 & 干预措施
Cohort 1
Experimental
post operative combination of gefinib and RT
干预措施: Gefitinib (Drug)
Cohort 2
Experimental
combination of gefitinib with RT and Chemotherapy in non operated patients
干预措施: Gefitinib (Drug)
结局指标
主要结局
To evaluate the feasibility and safety of (cohort 1) postoperative standard fractionation radiotherapy plus Iressa and of (cohort 2) hyperfractionated radiotherapy plus cisplatin and Iressa
次要结局
- Both cohorts overall survival (OS) local control (LC) rate at six months and at one year
- Cohort 1 only time-to-recurrence (TTR)
- Cohort 2 only time-to-progression (TTP). Complete Response (CR) rate time to treatment failure (TTF)
研究者
研究点 (1)
Loading locations...
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