NCT00986284暂停2 期
Phase II Study of EGFR Status Based Gefitinib Neoadjuvant Therapy in NSCLC Patients
Tianjin Medical University Cancer Institute and Hospital1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2009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
- 暂停
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Response Rate
研究概览
简要总结
This study aims to investigate the efficacy and safety of gefitinib as neoadjuvant therapy in stage IIIA NSCLC patients.
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
- •Patients pathological diagnosed with NSCLC,with EGFR sensitive mutation;
- •Stage IIIA patients with technical operable disease evaluated by image and lab results;
- •Patients without chemotherapy or targeted-therapy before;
- •Inform Consent.
排除标准
- •Patients with malignant tumor other than lung cancer;
- •Patients with other diseases such as cardiovascular disease that may hamper follow up;
- •Patients that may not coordinate well,judged by researcher.
研究组 & 干预措施
Gefitinib, Neoadjuvant therapy
Experimental
Patients with EGFR mutation will be recruited and treated with gefitinib.
干预措施: gefitinib (Drug)
结局指标
主要结局
Response Rate
时间窗: 1 month
次要结局
未报告次要终点
研究者
研究点 (1)
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未知
不适用
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