NCT01941953已完成2 期
Phase II Study of Metformin and 5-fluorouracil in Patients With Advanced Colorectal Cancer Previously Treated With Oxaliplatin and Irinotecan Based Chemotherapy.
Instituto do Cancer do Estado de São Paulo1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2012年11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
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Disease Control Rate according to RECIST 1.1
研究概览
简要总结
This is a phase II trial to evaluate efficacy and safety of Metformin and Fluorouracil in patients with metastatic colorectal cancer (CRC) who have progressed after Oxaliplatin and Irinotecan based chemotherapy.
详细描述
Primary Outcomes Measures:
- Disease control Rate at 8 weeks according to RECIST 1.1 (Tumor response was defined as the percentage of patients with complete response, partial response or stable disease as best overall response).
Secondary Outcome Measures:
- Progression-free Survival
- Overall Survival
- Adverse Events (assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Metformin and Flourouracil
Experimental
干预措施: Metformin and Fluorouracil (Drug)
结局指标
主要结局
Disease Control Rate according to RECIST 1.1
时间窗: From randomization of the first subject until the database cut-off approximately 12 months later (01Nov2012 up to 01Nov2015). Tumor assessed at 8 week intervals
次要结局
- Overall Survival(From randomization of the first subject until the database cut-off approximately 12 months later (01Nov2012 up to 01Nov2015). Tumor assessed at 4 week intervals)
- Adverse Events(From randomization of the first subject until the database cut-off approximately 12 months later (01Nov2012 up to 01Nov2015). Tumor assessed at 4 week intervals.)
- Progression-free Survival(From randomization of the first subject until the database cut-off approximately 12 months later (01Nov2012 up to 01Nov2015). Tumor assessed at 4 week intervals.)
研究者
Vanessa C Miranda
Fellow in Clinical Oncology
Instituto do Cancer do Estado de São Paulo
研究点 (1)
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