NCT01810367已完成2 期
ABX Combined With Cisplatin Compared With Gemcitabine Combined With Cisplatin in First Line Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer Stage II Randomized Controlled Trials
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
Assess the PFS/ORR/OS of ABX Combined With Cisplatin Compared With Gemcitabine Combined With Cisplatin in first Treatment of NSCLC
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
- 未提供
排除标准
- •Patients have used drugs according to protocol
- •Patients were allergic to pemetrexed or cisplatin
- •Patients received radiotherapy or other biological treatment 4 weeks before the trial
- •Uncontrolled hydrothorax or hydropericardium
- •neuropathy toxicity ≥ CTC 3
- •Severe symptomatic heart disease
- •Active upper gastrointestinal ulcer or digestive disfunction
- •Severe infection or metabolic disfunction
- •Patients with other malignant tumor
- •Uncontrolled brain metastases
- •Patients have accepted other clinical trials
- •Female patients during their pregnant and lactation period, or patients without contraception
研究组 & 干预措施
ABX Combined With Cisplatin
Experimental
ABX，100mg/m2，d1、8、15，ivgtt,in 30 min，28day one cycle； cisplin 75mg/m2 d1 ivgtt
干预措施: ABX Combined With Cisplatin (Drug)
Gemcitabine Combined With Cisplatin
Active Comparator
gemcitabine 1000mg/m2，d1、8；cisplatin 75mg/m2 d1 ivgtt,3 weeks one cycle.
干预措施: Gemcitabine Combined With Cisplatin (Drug)
结局指标
主要结局
PFS
时间窗: from the first cycle of treatment (day one) to two month after the last cycle
次要结局
未报告次要终点
研究者
Chang Jian Hua
Vice director of department of chemotherapy
Fudan University
研究点 (1)
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