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Iodine

Ethiodized Oil

Cadexomer iodine

Patients receive an intra-arterial infusion of iodine I 131 ethiodized oil.

Patients receive an intra-arterial infusion of unlabeled ethiodized oil.

ethiodized oil

iodine I 131 ethiodized oil

Jerome Dumortier, MD

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.

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.

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

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

Hospices Civils de Lyon

adjuvant therapy

London L. Ooi Peng Jin, MD

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.

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

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

National Medical Research Council (NMRC), Singapore

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Iodine I 131 Ethiodized Oil in Preventing Recurrent Cancer in Patients Who Have Undergone Treatment for Liver Cancer	NCT00870558	Liver Cancer	ethiodized oil iodine I 131 et...	18 Years -	National Cancer Institute (NCI)
Radioactive Iodine in Treating Patients Who Have Undergone Surgery for Liver Cancer	NCT00027768	Liver Cancer	adjuvant therap... iodine I 131 et...	17 Years -	National Cancer Institute (NCI)
Iodine I 131 Ethiodized Oil in Preventing Recurrent Cancer in Patients Who Have Undergone Treatment for Liver Cancer	NCT00870558	Liver Cancer	ethiodized oil iodine I 131 et...	18 Years -	National Cancer Institute (NCI)

Spots Global Cancer Trial Database for iodine i 131 ethiodized oil