Ignite Creation Date:
2025-12-24 @ 5:45 PM
Ignite Modification Date:
2026-01-01 @ 1:37 PM
Study NCT ID:
NCT00027768
Status:
UNKNOWN
Last Update Posted:
2013-09-20
First Post:
2001-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radioactive Iodine in Treating Patients Who Have Undergone Surgery for Liver Cancer
Sponsor:
National Medical Research Council (NMRC), Singapore
Organization:
Study Overview
Official Title:
Randomised Trial of Adjuvant Hepatic Intra-Arterial Iodine-131-Lipiodol Following Curative Resection of Hepatocellular Carcinoma
Status:
UNKNOWN
Status Verified Date:
2007-06
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
PURPOSE: Randomized phase III trial to determine the effectiveness of radioactive iodine in treating patients who have undergone surgery for liver cancer.
Detailed Description:
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.
* 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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: