Adjuvant Treatment by Intra-arterial Injection of Lipiodol-labeled Iodine-131 in Preventing Recurrence of Hepatocellular Carcinoma After Curative Treatment
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Tumor recurrence at 2 years
研究概览
简要总结
RATIONALE: Iodine I 131 ethiodized oil may help prevent or delay the recurrence of cancer. It is not yet known whether iodine I 131 ethiodized oil is more effective than non-radiolabeled ethiodized oil in preventing recurrent cancer in patients who have undergone treatment for liver cancer.
PURPOSE: This randomized phase III trial is studying iodine I 131 ethiodized oil to see how well it works compared with non-radiolabeled ethiodized oil in preventing recurrent cancer in patients who have undergone treatment for liver cancer.
详细描述
OBJECTIVES:
Primary
- Determine whether treatment with adjuvant intra-arterial iodine I 131 ethiodized oil reduces the percentage of tumor recurrence in patients with curatively treated hepatocellular carcinoma.
Secondary
- Evaluate the overall and recurrence-free survival of these patients.
- Evaluate the deterioration of liver function in these patients.
- Evaluate the toxicity of intra-arterial iodine I 131 ethiodized oil in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm I
Patients receive an intra-arterial infusion of iodine I 131 ethiodized oil.
干预措施: iodine I 131 ethiodized oil (Radiation)
Arm II
Patients receive an intra-arterial infusion of unlabeled ethiodized oil.
干预措施: ethiodized oil (Drug)
结局指标
主要结局
Tumor recurrence at 2 years
次要结局
未报告次要终点