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临床试验/NCT00743964
NCT00743964已完成2 期

A Randomized Phase II Study of Combination Chemotherapy With Epirubicin , Cisplatin and Capecitabine (ECX) or Cisplatin and Capecitabine (CX) in Advanced Gastric Cancer

Samsung Medical Center1 个研究点 分布在 1 个国家目标入组 91 人开始时间: 2008年4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
91
试验地点
1
主要终点
Failure-free survival

研究概览

简要总结

Recently, 3-drug (ECX) and 2-drug (CX) combination chemotherapy involving capecitabine showed promising results in randomized clinical trials for advanced gastric cancer (AGC). The objective of the study is to evaluate the safety and activity of ECX and CX combination chemotherapy given as first-line therapy for AGC.

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
— 至 75 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 75 years or less
  • Adenocarcinoma of stomach
  • Advanced, metastatic, or recurrent
  • No prio chemotherapy for advanced disease
  • Adequate performance status
  • Adequate major organ functions

排除标准

  • Severe comorbid illness or active infections
  • Pregnancy or lactating women
  • GI obstruction or malabsorption syndrome

研究组 & 干预措施

ECX

Experimental

Epirubicin, cisplatin and capecitabine combination chemotherapy will be administered.

干预措施: Epirubicin (Drug)

ECX

Experimental

Epirubicin, cisplatin and capecitabine combination chemotherapy will be administered.

干预措施: Cisplatin, capecitabine (Drug)

CX

Active Comparator

Cisplatin and capecitabine combination chemotherapy will be administered.

干预措施: Cisplatin, capecitabine (Drug)

结局指标

主要结局

Failure-free survival

时间窗: six months

次要结局

  • progression-free survival(six months)

研究者

申办方类型
Other

研究点 (1)

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