NCT01194453已完成2 期
A Phase 2,Open-label Study of First Line Pemetrexed Plus Cisplatin Versus Gemcitabine Plus Cisplatin for Advanced and Metastatic Non Small Cell Lung Cancer and Biomarker Study
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 288 人开始时间: 2009年11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
- 已完成
- 发起方
- 入组人数
- 288
- 试验地点
- 1
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
A phase III trial has demonstrated that in advanced non-small cell lung cancer (NSCLC) cisplatin/ pemetrexed provides similar efficacy with better tolerability and more convenient administration than cisplatin/gemcitabine. Moreover,this trial showed survival differences based on histologic type. The investigators want to research some biomarkers that can predict clinical outcomes.
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
- •Chemotherapy-naive patients with histologically or cytologically confirmed adenocarcinoma and large-cell carcinoma, classified as stage IIIB not amenable to curative treatment or stage IV
- •With at least one unidimensionally measurable lesion according to the Response Evaluation Criteria in Solid Tumors;
- •with an Eastern CooperativeOncology Group performance status of 0 or 1,
- •At least 18 years of age
- •adequate bone marrow reserve and organ function including calculated creatinine clearance 45 mL/min based on the standard Cockcroft and Gault formula.
- •Prior radiation therapy was permitted if it was completed at least 4 weeks before study treatment
- •patients had fully recovered from its acute effects.
排除标准
- •peripheral neuropathy > National Cancer Institute Common Toxicity Criteria grade 1
- •progressive brain metastases,
- •uncontrolled third-space fluid retention before study entry.
- •Patients unable to interrupt aspirin and other nonsteroidal anti-inflammatory drugs or if they were unable or unwilling to take folic acid, vitamin B12, or corticosteroids.
研究组 & 干预措施
Group A
Experimental
干预措施: cisplatin, dexamethasone,vitamin B12, folic acid (Drug)
Group B
Active Comparator
干预措施: cisplatin, gemcitabine (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: 36months
次要结局
- Response Rate(6 weeks)
研究者
Li Zhang
Professor
Sun Yat-sen University
研究点 (1)
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