NCT00195572已完成3 期
Post-Approved Phase III Study of 1-LV/5FU Therapy
Wyeth is now a wholly owned subsidiary of Pfizer43 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2002年5月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 43
- 主要终点
- Survival time
研究概览
简要总结
The purpose of the study is to verify non-inferiority of survival time between Isovorin/5-fluorouracil (1-LV/5FU) therapy and TS-1 therapy in patients with inoperable advanced or recurrent gastric cancer. Secondary endpoints include response rates, duration of responses, time to progression (TTP) safety and quality of life (QOL).
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
- 20 Years 至 77 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gastric cancer diagnosed histologically or cytologically
- •Normal organ function of bone marrow, heart, liver and kidney
- •Age of 20-77
- •Other inclusion applies
排除标准
- •Serious infection, heart disease, complication or organ disorder
- •Ongoing administration of flucytosine
- •Pregnant or breastfeeding women
- •Other exclusion applies
结局指标
主要结局
Survival time
次要结局
- Response rate, duration of response, time to progression, safety, quality of life
研究者
研究点 (43)
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