Phase III Trial Comparing 2 Chemotherapy Schedules (Preoperative vs Pre and Postoperative) in Stage I and II NSCLC
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 530
- 试验地点
- 1
- 主要终点
- Compare 3-Years survival
研究概览
简要总结
The addition of chemotherapy to lung cancer surgery is now considered as the standard of care. Solid data support postoperative chemotherapy but only few results are available in the preoperative setting. To define which timing of perioperative chemotherapy offers the best survival improvement, the IFCT 0002 study is conducted in France.
详细描述
In this multicenter study, patients are randomized to receive either two preoperative chemotherapy cycles plus two additional preoperative cycles if they respond to chemotherapy, or two preoperative plus two postoperative cycles in case of response.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically NSCLC stade I or II Resectable disease WHO performance status of 2 or less
排除标准
- •NSCLC stage III or IV
研究组 & 干预措施
A: pre-operative chemotherapy
pre-operative chemotherapy (gemcitabine+cisplatine, 4 cycles)
干预措施: gemcitabine + cisplatine (Drug)
B: pre-operative chemotherapy
pre-operative chemotherapy (paclitaxel+carboplatin, 4 cycles)
干预措施: gemcitabine + cisplatine (Drug)
C: peri-operative chemotherapy
peri-operative chemotherapy (gemcitabine+cisplatine, 4 cycles)
干预措施: Paclitaxel + Carboplatine (Drug)
D: peri-operative chemotherapy
peri-operative chemotherapy (paclitaxel+carboplatin, 4 cycles)
干预措施: Paclitaxel + Carboplatine (Drug)
结局指标
主要结局
Compare 3-Years survival
时间窗: 3 years
次要结局
- Compare Objective response rate(6 weeks)