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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Adjuvant Treatment by Intra-arterial Injection of Lipiodol-labeled Iodine-131 in Preventing Recurrence of Hepatocellular Carcinoma After Curative Treatment

Conditions
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Liver Cancer

Intervention / Treatment
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* Drug: ethiodized oil
* Radiation: iodine I 131 ethiodized oil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I<br>Patients receive an intra-arterial infusion of iodine I 131 ethiodized oil. | Radiation: iodine I 131 ethiodized oil<br>* Given as an intra-arterial infusion<br>|
| Placebo Comparator: Arm II<br>Patients receive an intra-arterial infusion of unlabeled ethiodized oil. | Drug: ethiodized oil<br>* Given as an intra-arterial infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor recurrence at 2 years |  |  | 

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