NCT00169221终止2 期
CARISSA Trial - Multicenter Randomized Phase II Trial Comparing Post-operative Radiotherapy and Cisplatin Alone or in Combination With the EGFR Inhibitor ZD 1839 (Iressa) in Upper Aerodigestive Tract Carcinomas
Groupe Oncologie Radiotherapie Tete et Cou1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2005年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Disease free survival
研究概览
简要总结
This trial will be an open multicentric randomized phase II study comparing post-operative radiotherapy + cisplatin associated or not with Iressa in upper aerodigestive tract carcinomas.
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
- •Patients with upper aerodigestive tract carcinomas (all sites included) having surgical resection and eligible for post-operative radiation + cisplatin.
- •Patient having a tumoral biopsy (0.5 - 1 cm3) stored in liquid nitrogen at time of surgical resection (patients with small tumors located in larynx for instance will not be included)
- •Patients receiving post-operative radiation (>=60 Gy on tumor bed and/or cervical area), associated with cisplatin, 6 weeks after surgery at the latest.
排除标准
- •previous history of cancer (except skin basal cell carcinoma)
研究组 & 干预措施
postop chemoradio with cisplatin
Active Comparator
postoperative chemoradiotherapy with cisplatin
干预措施: chemoradiotherapy with cisplatin (Radiation)
postop chemoradio (cisplatin)+gefitinib
Experimental
postoperative chemoradiotherapy with cisplatin + gefitinib
干预措施: Iressa (Gefitinib) (Drug)
结局指标
主要结局
Disease free survival
时间窗: 3 years
次要结局
未报告次要终点
研究者
研究点 (1)
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