NCT01238094Unknown3 期
Placebo-controlled, Double-blinded Phase III Trial of XELIRI/FOLFIRI + Simvastatin Followed by Simvastatin Maintenance in Metastatic Colorectal Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 258
- 试验地点
- 1
- 主要终点
- Progression free survival
研究概览
简要总结
The purpose of this study is to compare 2nd line XELIRI/FOLFIRI + simvastatin vs XELIRI/FOLFIRI + placebo.
详细描述
To compare progression free survival of the standard second line chemotherapy (FOLFIRI, XELIRI) plus simvastatin in metastatic colorectal cancer patients. This trial is a placebo-controlled study.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically documented colorectal adenocarcinoma (previously failed to oxaliplatin)
- •Age over 19 years old
- •Performance status (ECOG scale): 0-2
- •Measurable or evaluable disease
- •Adequate organ functions
- •Life expectancy ≥ 3 months
- •No history of statin treatment within the last 12 months
- •Patients should sign a written informed consent before study entry.
排除标准
- •Tumor type other than adenocarcinoma
- •Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin, papillary thyroid carcinoma or prior malignancy treated more than 5 years ago without recurrence)
- •Adjuvant or neo-adjuvant treatment for non-metastatic (M0) disease is allowed if completed at least 6 months prior to initiation of study treatment.
- •Prior radiotherapy is permitted if it was not administered to target lesions selected for this study, unless progression of the selected target lesions within the radiation portal is documented, and provided it has been completed at least 4 weeks before randomization.
研究组 & 干预措施
FOLFIRI or XELIRI/simvastatin
Experimental
FOLFIRI or XELIRI/simvastatin
干预措施: Simvastatin (Drug)
结局指标
主要结局
Progression free survival
时间窗: 12 months
次要结局
未报告次要终点
研究者
研究点 (1)
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