NCT02903498已完成2 期
Phase II Study of the Maintenance Treatment of UFT (Uracil and Tegafur) After First-line
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
- 58
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and tolerability of the maintenance treatment of tegafur-uracil (UFT) after the standard first-line chemotherapy in advanced gastric cancer.
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
- 否
入选标准
- •Histologically confirmed advanced or metastatic adenocarcinoma of the stomach
- •ECOG PS 0-2
- •At least one measurable or evaluable lesion in the first-line chemotherapy (5-FU based regimen: ECF/EOF/EOX/FOLFOX/XELOX) with the efficacy evaluation of non-PD
- •Adequate hepatic,renal,heart, and hematologic functions (platelets ≥75×109/L, neutrophil≥1.5×109/L, hemoglobin≥80 g/L, serum creatinine ≤1.5mg/dl, total bilirubin ≤1.5mg/dl, and serum transaminase≤2.5×the ULN)
排除标准
- •Receiving more or more than 2 regimens of chemotherapy
- •Pregnant or lactating women
- •Concurrent cancer
- •History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
- •Neuropathy, brain, or leptomeningeal involvement
- •Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months or high risk/uncontrolled arrhythmia
- •Uncontrolled significant comorbid conditions and previous radiotherapy
研究组 & 干预措施
UFT treatment
Experimental
Uracil and Tegafur
干预措施: UFT (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: six weeks
PFS is calculated from the start of treatment to disease progression or death
次要结局
- Overall Survival (OS)(six weeks)
- Number of Participants with Adverse Events(six weeks)
研究者
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Unknown
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Unknown
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