Iodine I 131 Ethiodized Oil in Preventing Recurrent Cancer in Patients Who Have Undergone Treatment for Liver Cancer

Overview

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.

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. OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive an intra-arterial infusion of iodine I 131 ethiodized oil. * Arm II: Patients receive an intra-arterial infusion of unlabeled ethiodized oil. After completion of study treatment, patients are followed periodically for 5 years.

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Interventions