Iodine I 131 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.

DISEASE CHARACTERISTICS:

• Diagnosis of hepatocellular carcinoma (HCC)

• Alpha-fetoprotein < 20 ng/mL
• Must have undergone curative treatment for HCC within the past 8-20 weeks, including 1 of the following:

• Curative resection
• Alcohol ablation, radiofrequency ablation, or cryotherapy (for 1 or 2 nodules < 5 cm in diameter)
• No ascites
• No other intrahepatic involvement or nodule progression as assessed by ultrasound
• No extrahepatic metastases

PATIENT CHARACTERISTICS:

• WHO performance status 0-2
• ANC ≥ 1,500/mm³
• Platelet count ≥ 50,000/mm³
• Bilirubin ≤ 51 μmol/L
• Creatinine ≤ 120 μmol/L
• Not pregnant or nursing
• Negative pregnancy test
• Child-Pugh score < 8 (class B)
• No decompensated cirrhosis
• No encephalopathy
• No uncontrolled bleeding
• No portal thrombosis, right- or left-branch thrombosis, extrahepatic thrombosis, or portal reflux by doppler or CT scan
• No unstable medical or surgical disease
• No contraindication to vascular arteriography
• No history of complications after injection of iodine contrast agents
• Not incarcerated

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• Recovered from all prior therapy
• No prior hormonal treatment, including tamoxifen and somatostatin analogs
• No prior systemic chemotherapy