Radioactive Iodine in Treating Patients Who Have Undergone Surgery for Liver Cancer
Recruitment status was: Active, not recruiting
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.
Procedure: adjuvant therapy
Radiation: iodine I 131 ethiodized oil
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||Randomised Trial of Adjuvant Hepatic Intra-Arterial Iodine-131-Lipiodol Following Curative Resection of Hepatocellular Carcinoma|
- Recurrence-free survival [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
|Study Start Date:||June 2001|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00027768
|National Cancer Centre - Singapore|
|Singapore, Singapore, 169610|
|Tan Tock Seng Hospital|
|Singapore, Singapore, 308433|
|Changi General Hospital|
|Singapore, Singapore, 529889|
|Study Chair:||London L. Ooi Peng Jin, MD||National Cancer Centre, Singapore|