NCT00168155已完成2 期
Phase 2 Study of Neoadjuvant 5-FU + Leucovorin + CPT-11 in Patients With Resectable Liver Metastases From Colorectal Adenocarcinoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- disease free survival
研究概览
简要总结
When colon or rectal cancer has spread to the liver, the cancer in the liver can sometimes be removed surgically. However, the cancer has a chance or reoccurring in the liver or elsewhere in the body. This study will determine if giving chemotherapy treatment before the surgery can reduce the chances that the cancer will come back.
详细描述
When colon or rectal cancer has spread to the liver, the cancer in the liver can sometimes be removed surgically. However, the cancer has a chance or reoccurring in the liver or elsewhere in the body. This study will determine if giving chemotherapy treatment before the surgery can reduce the chances that the cancer will come back.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •stage IV colorectal cancer isolated to the liver
- •one measurable lesion
- •metastases are completely resectable or amenable to ablation
- •Karnofsky >70
- •Adequate bone marrow function
- •adequate hepatic function
- •adequate renal function
- •informed consent
排除标准
- •primary tumor not controlled by locoregional treatments
- •bilateral portal vein and/or hepatic artery involvement
- •previous chemotherapy directed at treatment of metastatic colorectal cancer
- •underlying acute or chronic liver disease
- •Gilbert's disease
- •patients receiving phenytoin or phenobarbital prophylaxis
- •presence of any concurrent medical or psychiatric condition that serves as a contraindication to surgery or chemotherapy
- •pregnancy
- •malignancy other than basal cell or squamous cell carcinoma of the skin within the preceding 5 years
- •use of another investigational medication concurrently or within 4 months of enrollment
结局指标
主要结局
disease free survival
次要结局
未报告次要终点
研究者
研究点 (2)
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