Cisplatin Combined With Irinotecan or Etoposide for Untreated Extensive-stage Small Cell Lung Cancer: a Multicenter Randomized Control Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- progression-free survival
研究概览
简要总结
Patients with untreated extensive-stage small cell lung cancer(SCLC) were randomly assigned to receive either irinotecan/cisplatin (IP) or etoposide/cisplatin(EP), The association of efficacy and toxicity of IP regimen was analyzed.
详细描述
This is a randomized, multicenter study. Patients are randomized to irinotecan/cisplatin (IP) or etoposide/cisplatin (EP) treatment arms. The IP regimen consisted of at most 6 cycles of irinotecan 65 mg/m2 of body-surface area on days 1, 8 and cisplatin 75mg/m2 of body-surface area on day 1. The EP regimen consisted of at most 6 cycles of etoposide 100 mg/m2 of body-surface area from day 1 to 3 and cisplatin 75mg/m2 of body-surface area on day 1. Cycle length for the two arms was 3 weeks. The dose adjustment was allowed in at most within ±5% per investigator discretion if necessary.
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 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eastern Cooperative Oncology Group (ECOG) of 0 to 2
- •A life expectancy of at least 3 months
- •Measurable lesions
- •Adequate hematologic function
排除标准
- •Infection
- •Myocardial infarction within the preceding three months
- •Symptomatic brain metastases or receiving radiotherapy less than 4 weeks
- •Pregnancy or breast-feeding
研究组 & 干预措施
Irinotecan and cisplatin
The IP regimen consisted of at most 6 cycles of irinotecan 65 mg/m2 of body-surface area on days 1, 8 and cisplatin 75mg/m2 of body-surface area on day 1.
干预措施: Irinotecan and cisplatin (Drug)
Etoposide and Cisplatin
The EP regimen consisted of at most 6 cycles of etoposide 100 mg/m2 of body-surface area from day 1 to 3 and cisplatin 75mg/m2 of body-surface area on day 1.
干预措施: Etoposide and cisplatin (Drug)
结局指标
主要结局
progression-free survival
时间窗: 1 month
次要结局
未报告次要终点
研究者
Shi Yuankai
Cancer Institute/Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Chinese Academy of Medical Sciences
