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临床试验/NCT00168896
NCT00168896Unknown2 期

A Randomised Phase II/III Study to Compare the Combination of Carboplatin Plus Irinotecan Vs. the Combination of Carboplatin Plus Etoposide for SCLC in Extensive Disease Stage

Charite University, Berlin, Germany2 个研究点 分布在 1 个国家目标入组 286 人开始时间: 2001年10月最近更新:
适应症
相关药物

试验速览

阶段
2 期
入组人数
286
试验地点
2
主要终点
Primary Endpoint:

研究概览

简要总结

Comparison of two combination chemotherapies in the treatment of patients with SLCL

详细描述

Comparison of two combination chemotherapies in the treatment of patients with SLCL

The combination chemotherapies for this study are Carboplatin plus Irinotecan versus Carboplatin plus Etoposide.

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

入选标准

  • cytological or histological proven SCLC Stage I or II at 1st diagnosis
  • no prior chemotherapy
  • measurable tumor disease
  • karnofsky performance 70

排除标准

  • second malignancy ( except basal cell carcinoma, CA in situ Cervix uteri)
  • chronic diarrhea, obstructive bowel syndrome

结局指标

主要结局

Primary Endpoint:

Documentation of the remission rate ( Phase II)

Determination of progress free time (Phase III)

次要结局

  • Secondary Endpoint:
  • Documentation of progress free time (Phase II)
  • Documentation of objective remission rate ( Phase III)
  • Documentation of 1-year survival rate
  • Documentation of safety of the drug combination

研究者

申办方类型
Other

研究点 (2)

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