Radioactive Iodine in Treating Patients Who Have Undergone Surgery for Liver Cancer
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|ClinicalTrials.gov Identifier: NCT00027768|
Recruitment Status : Unknown
Verified June 2007 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : September 20, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Liver Cancer||Procedure: adjuvant therapy Radiation: iodine I 131 ethiodized oil||Phase 3|
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Official Title:||Randomised Trial of Adjuvant Hepatic Intra-Arterial Iodine-131-Lipiodol Following Curative Resection of Hepatocellular Carcinoma|
|Study Start Date :||June 2001|
- Recurrence-free survival
- Overall survival
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|