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临床试验/NCT02395640
NCT02395640已完成3 期

The Comparison of XELOX and EOX in the First-line Treatment of Advanced Gastric Cancer: An Open-label, Multi-center, Prospective and Randomised Study

Fudan University1 个研究点 分布在 1 个国家目标入组 438 人开始时间: 2015年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
438
试验地点
1
主要终点
progression free survival

研究概览

简要总结

This study is designed to compare the efficacy and safety of XELOX regimen with EOX regimen in the first-line treatment of advanced gastric cancer patients.

详细描述

This study is designed to compare the efficacy and safety of XELOX regimen with EOX regimen in the first-line treatment of advanced gastric cancer patients.

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

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

XELOX

Experimental

oxaliplatin 130mg/m2 d1; capecitabine 1000mg/m2 Bid po,d1-14;

干预措施: Oxaliplatin (Drug)

XELOX

Experimental

oxaliplatin 130mg/m2 d1; capecitabine 1000mg/m2 Bid po,d1-14;

干预措施: Capecitabine (Drug)

EOX

Active Comparator

Epirubicin 50mg/m2 d1; oxaliplatin 130mg/m2 d1; capecitabine 1000mg/m2 Bid po,d1-14;

干预措施: Epirubicin (Drug)

EOX

Active Comparator

Epirubicin 50mg/m2 d1; oxaliplatin 130mg/m2 d1; capecitabine 1000mg/m2 Bid po,d1-14;

干预措施: Oxaliplatin (Drug)

EOX

Active Comparator

Epirubicin 50mg/m2 d1; oxaliplatin 130mg/m2 d1; capecitabine 1000mg/m2 Bid po,d1-14;

干预措施: Capecitabine (Drug)

结局指标

主要结局

progression free survival

时间窗: 7 months

次要结局

  • overall survival(10 months)
  • quality of life questionnaire(2 months)
  • overall response rate(2 months)
  • Number of Participants with Adverse Events(2 months)

研究者

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

Weijian Guo

Professor

Fudan University

研究点 (1)

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