Randomized Phase II Trial of Two Different Schedules of Docetaxel Plus Cisplatin as First-Line Therapy in Advanced Non-Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Objective response rate
研究概览
简要总结
To evaluate the toxicity and efficacy of docetaxel and cisplatin combination on two schedules in patients with previously untreated, advanced NSCLC.
详细描述
The combination of docetaxel 75 mg/m2 and cisplatin 60-80 mg/m2 administered every 3 weeks is one of the most commonly used chemotherapy regimen in Korea for the first-line treatment of advanced NSCLC. Although the 3-weekly regimen is active and tolerated, it is associated with a significant incidence of severe neutropenia, often complicated by fever. Therefore, there has been increasing interest in the use of a weekly administration of docetaxel as a way of reducing its hematologic toxicity. We designed this randomized phase II trial to evaluate the safety profile and antitumor activity of two different schedules of docetaxel plus cisplatin given as first-line therapy in patients with advanced 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
- •histologically or cytologically proven non-small cell lung cancer
- •no prior chemotherapy or only adjuvant chemotherapy which had been completed >6 months before registration
- •ECOG performance status 0 to 2
- •measurable lesion(s)
- •normal marrow, hepatic and renal functions
- •provision of written informed consent
排除标准
- •active infection or severe comorbidities
- •history of anaphylaxis of any origin
结局指标
主要结局
Objective response rate
次要结局
- Progression-free survival
- Overall survival
- Safety