Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00027768
Status:
UNKNOWN
Last Update Posted:
2013-09-20
First Post:
2001-12-07
Brief Title:
Radioactive Iodine in Treating Patients Who Have Undergone Surgery for Liver Cancer
Sponsor:
National Medical Research Council NMRC Singapore
Organization:
National Cancer Institute NCI
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?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-20128 | None | None | None |
| NMRC-AHCC03 | None | None | None |