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临床试验/NCT02323737
NCT02323737已完成2 期

Cisplatin Combined With Irinotecan or Etoposide for Untreated Extensive-stage Small Cell Lung Cancer: a Multicenter Randomized Control Clinical Trial

Chinese Academy of Medical Sciences1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2010年7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
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

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

Active Comparator

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

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shi Yuankai

Cancer Institute/Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

Chinese Academy of Medical Sciences

研究点 (1)

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