Radioactive Iodine in Treating Patients Who Have Undergone Surgery for Liver Cancer
This trial is active, not recruiting.
|Treatments||adjuvant therapy, iodine i 131 ethiodized oil|
|Sponsor||National Medical Research Council (NMRC), Singapore|
|Start date||June 2001|
|Trial size||300 participants|
|Trial identifier||NCT00027768, CDR0000069066, EU-20128, NMRC-AHCC03|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
Male or female participants at least 17 years old.
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: Age: - 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 Hepatic: - Bilirubin less than 2.92 mg/dL - PT less than 4 seconds over control Renal: - Creatinine less than 2.26 mg/dL Other: - 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 Surgery - See Disease Characteristics - Recovered from prior surgery Other - No other prior treatment for HCC
|Official title||Randomised Trial of Adjuvant Hepatic Intra-Arterial Iodine-131-Lipiodol Following Curative Resection of Hepatocellular Carcinoma|
|Description||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.|
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