NCT02614339Unknown3 期
Effect of Adjunctive Metformin on Recurrence of Non-DM Colorectal Cancer Stage II High-risk/ III Colorectal Cancer: Open-label Randomized Controlled
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 593
- 试验地点
- 1
- 主要终点
- Disease free survival
研究概览
简要总结
The aim of this study is to identify the effect of adjunctive metformin on recurrence of non-DM Stage II High-risk/ III colorectal cancer. This study is open-label randomized controlled study.
The primary endpoint is to compare the 3-year disease free survival between metformin group and non-metformin group. The secondary endpoint is to compare the 5-year overall survival and disease specific survival between two group, to identify the safety of metformin, and to compare the recurrence rate of polyps after polypectomy between two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with stage II high-risk/ III colorectal cancer who were taken an operation for cure, or patients with stage III rectal cancer who were taken an chemoradiation therapy and subsequently operation
- •age 20 - 80 years
- •patients without DM
- •patients who have well performance status for chemotherapy
- •patients who are agreed the study protocol
排除标准
- •patients with DM
- •patients who were diagnosed other cancers (≥ stage II) within 5 years
- •patients who have familial adenomatous polyposis, hereditary non-polyposis colorectal cancer, or inflammatory bowel disease
- •patients who are taken other chemoprevention drugs (ex. NSAIDs, Aspirin)
- •patients who have risk factors to increase lactic acidosis which are renal disease, lung disease, liver disease, or infectious disease
- •Creatinine ≥ 1.5mg/dL (for male), ≥ 1.4mg/dL (for female)
- •patients with congestive heart failure which is needed to treat
- •patients who have allergic history of metformin
研究组 & 干预措施
control
Active Comparator
干预措施: control (Drug)
metformin
Experimental
干预措施: metformin (Drug)
结局指标
主要结局
Disease free survival
时间窗: after 3 years
The primary endpoint is to compare 3-year disease free survival between metformin group and non-metformin group.
次要结局
- 5-year overall survival(after 5 years)
- recurrence rate of polyps after polypectomy(after 1 year, and then according to the findings in 1 year colonoscopy)
研究者
研究点 (1)
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