NCT00191763已完成2 期
Phase II Trial of Gemcitabine and Cisplatin as Neo-Adjuvant Chemotherapy for Operable Non-Small Cell Lung Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- To evaluate the clinical response rate of neo-adjuvant chemotherapy with gemcitabine and cisplatin in patients with operable non small cell lung cancer
研究概览
简要总结
Based on available data, the concept of neo-adjuvant chemotherapy seems to be promising for patients with resectable non-small cell lung cancer. The exploration of new drugs and regimens are warranted. Therefore the aim of this study is to evaluate the clinical response rate of neo-adjuvant chemotherapy with gemcitabine and cisplatin in patients with operable non-small cell lung cancer stage IB, IIA-B, IIIA.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •define histologic or cytologic diagnosis of non small cell lung cancer.
- •determine the presence of clinical Stage IB, IIA-B or IIIA disease in accordance with the revision by Mountain CF of American Joint Committee on Cancer.
- •define performance status of 0-1 on ECOG scale
- •do not have any prior tumor therapy
- •to be suitable for curative resection
排除标准
- •to have any treatment within the last 30 days with any investigational drug.
- •to get concurrent administration of any other tumor therapy
- •to be pregnant
- •to have poorly controlled diabetes mellitus
- •to have serious concomitant disorders.
结局指标
主要结局
To evaluate the clinical response rate of neo-adjuvant chemotherapy with gemcitabine and cisplatin in patients with operable non small cell lung cancer
次要结局
- To evaluate the safety of neo-adjuvant chemotherapy with gemcitabine / cisplatin
- To determine the complete tumor resection rate
- To evaluate overall survival and time to documented disease progression
研究者
研究点 (2)
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