Liver Cancer Clinical Trial
Official title:
Randomised Trial of Adjuvant Hepatic Intra-Arterial Iodine-131-Lipiodol Following Curative Resection of Hepatocellular Carcinoma
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.
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.
;
Allocation: Randomized, Primary Purpose: Treatment
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