Radioactive Iodine in Treating Patients Who Have Undergone Surgery for Liver Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Randomised Trial of Adjuvant Hepatic Intra-Arterial Iodine-131-Lipiodol Following Curative Resection of Hepatocellular Carcinoma

Conditions
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Liver Cancer

Intervention / Treatment
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* Procedure: adjuvant therapy
* Radiation: iodine I 131 ethiodized oil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: adjuvant therapy|nan|
|Radiation: iodine I 131 ethiodized oil|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence-free survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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localized resectable adult primary liver cancer, adult primary hepatocellular carcinoma