Hepatic Arterial Infusion of Oxaliplatin Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- number of patients who become eligible for total resection of metastatic liver tumor
研究概览
简要总结
Hepatic artery infusion (HAI) with oxaliplatin (OX), systemic 5 fluorouracil (5FU), and leucovorin (HAI/OX/FU) will be implemented using an interventional radiology technique to obviate the need for initial major surgery (catheter placement) in patients who have unresectable liver metastasis from colorectal cancer. The study goal is to reduce tumor size to make possible a complete resection of all lesions. Secondary goals are to reduce or eliminate the complexity usually associated with HAI, to accomplish most or all of the treatment as an outpatient, to reduce costs, and to avoid the hepatotoxicity associated with HAI/floxuridine (FUDR). Oxaliplatin has been selected because of its ease of use, known toxicology, and established efficacy in colorectal cancer.
详细描述
After entry qualification and registration patients will undergo hepatic artery catheterization via interventional radiology. The catheter will remain in place for two hours while oxaliplatin is infused and then be removed. This treatment will be followed by a 48 hour infusion of 5FU and leucovorin, generally following the principle of FOLFOX 6. These cycles of therapy will be repeated biweekly for six episodes. Hepatic tumor size will be evaluated by CT scan to determine if resectability has been established as the result of tumor size reduction. If so, the patient will be offered resection of the residual lesions in an effort to achieve long term survival.
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
- •Signed consent
- •Age greater than 17 years
- •Stage IV colorectal cancer
- •Metastasis limited to the liver considered unresectable for cure by standard methods
- •Completely resected primary tumor
- •Life expectancy greater than 3 years excluding cancer
- •Eastern Cooperative Oncology Group (ECOG) status 0, 1, 2
- •Absolute granulocyte count greater than 1500
- •Platelet count greater than 100,000
- •Adequate hepatic function
- •Adequate renal function
排除标准
- •Concomitant anticancer therapy other than this protocol
- •Gastroduodenal ulcer
- •Pregnancy or lactation
- •Last treatment for colon cancer less than 4 weeks from this protocol
结局指标
主要结局
number of patients who become eligible for total resection of metastatic liver tumor
overall survival of patients resected for cure versus (vs.) resected for palliation vs. not resected.
次要结局
- toxicity
- HAI complexity
- cost