Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 12:16 AM
NCT ID:
NCT00870558
Brief Summary:
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:
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.
Study:
NCT00870558
Study Brief:
Protocol Section:
NCT00870558