NCT00027768Unknown3 期
Randomised Trial of Adjuvant Hepatic Intra-Arterial Iodine-131-Lipiodol Following Curative Resection of Hepatocellular Carcinoma
National Medical Research Council (NMRC), Singapore6 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2001年6月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 300
- 试验地点
- 6
- 主要终点
- Recurrence-free survival
研究概览
简要总结
RATIONALE: Radioactive iodine may be effective in reducing the rate of recurrence of liver cancer after surgery to remove the tumor. It is not yet known if radioactive iodine is more effective than no further treatment after surgery.
PURPOSE: Randomized phase III trial to determine the effectiveness of radioactive iodine in treating patients who have undergone surgery for liver cancer.
详细描述
OBJECTIVES:
- Compare the effect of adjuvant hepatic intra-arterial iodine I 131 lipiodol vs observation in terms of rate of recurrence and overall survival of patients with curatively resected hepatocellular carcinoma.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Within 4-6 weeks after prior resection, patients receive adjuvant hepatic intra-arterial iodine I 131 lipiodol once.
- Arm II: After prior resection, patients undergo observation. Patients are followed monthly for 1 year and then every 3 months thereafter.
PROJECTED ACCRUAL: A minimum of 300 patients (150 per treatment arm) will be accrued for this study.
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
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed primary hepatocellular carcinoma (HCC)
- •Completely resected disease with clear margins
- •No residual disease by postoperative CT scan
- •No metastatic disease
- •PATIENT CHARACTERISTICS:
- •17 and over
- •Performance status:
- •Karnofsky 60-100%
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •WBC greater than 1,500/mm^3
- •Platelet count greater than 50,000/mm^3
- •Bilirubin less than 2.92 mg/dL
- •PT less than 4 seconds over control
- •Creatinine less than 2.26 mg/dL
- •No contraindication to contrast or radioactive iodine
- •No uncontrolled thyrotoxicosis
- •No other prior or concurrent malignancy
- •Not pregnant or nursing
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •Not specified
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •Not specified
- •See Disease Characteristics
- •Recovered from prior surgery
- •No other prior treatment for HCC
排除标准
- 未提供
结局指标
主要结局
Recurrence-free survival
次要结局
- Overall survival
研究者
研究点 (6)
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