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About
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.
Full description
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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Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
Diagnosis of hepatocellular carcinoma (HCC)
Must have undergone curative treatment for HCC within the past 8-20 weeks, including 1 of the following:
No ascites
No other intrahepatic involvement or nodule progression as assessed by ultrasound
No extrahepatic metastases
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
120 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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