NCT00199173已完成3 期
Comparison Hepatic Intra-arterial Injection of Yttrium-90 Versus 5FU in Colorectal Cancer Metastatic to the Liver Only
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 试验地点
- 2
研究概览
简要总结
This is a Phase III trial comparing hepatic intra-arterial injection of Yttrium-90 microspheres (selective internal radiation [SIR] spheres) versus infusional intravenous (IV) 5FU in colorectal cancer metastatic to the liver only and refractory to standard IV chemotherapy.
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
- 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
- •Histologically proven colorectal adenocarcinoma, metastatic to the liver only.
- •Failure of prior chemotherapy for advanced colorectal cancer.
- •Adequate laboratory values of hematologic, renal and liver function
- •World Health Organization (WHO) performance status (PS) <= 2
- •Written consent
排除标准
- •Pregnant or lactating patients
- •Other tumor type than adenocarcinoma (leiomyosarcoma; lymphoma).
- •Patients with cirrhosis or other chronic liver disease
- •Thrombosis of the hepatic main artery of the portal vein
- •Lung shunting > 20% as determined by nuclear medicine breakthrough scan
- •Patients with serum bilirubin > 1.0 x upper limit of normal (ULN) or with AST and/or ALT and/or alkaline phosphatase > 5 x ULN
- •Patients with concurrent or within 4 week period administration of any other experimental drugs.
- •Other serious illness or medical conditions.
研究者
研究点 (2)
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