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Sponsored by: |
National Medical Research Council (NMRC), Singapore |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00027768 |
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 | Intervention | Phase |
---|---|---|
Liver Cancer |
Drug: iodine I 131 ethiodized oil Procedure: adjuvant therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | Randomised Trial of Adjuvant Hepatic Intra-Arterial Iodine-131-Lipiodol Following Curative Resection of Hepatocellular Carcinoma |
Estimated Enrollment: | 300 |
Study Start Date: | June 2001 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 2 treatment arms.
PROJECTED ACCRUAL: A minimum of 300 patients (150 per treatment arm) will be accrued for this study.
Ages Eligible for Study: | 17 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Singapore | |
Changi General Hospital | |
Singapore, Singapore, 529889 | |
National Cancer Centre - Singapore | |
Singapore, Singapore, 169610 | |
Tan Tock Seng Hospital | |
Singapore, Singapore, 308433 |
Study Chair: | London L. Ooi Peng Jin, MD | National Cancer Centre, Singapore |
Study ID Numbers: | CDR0000069066, NMRC-AHCC03, EU-20128 |
Study First Received: | December 7, 2001 |
Last Updated: | December 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00027768 |
Health Authority: | United States: Federal Government |
localized resectable adult primary liver cancer adult primary hepatocellular carcinoma |
Liver Diseases Digestive System Neoplasms Carcinoma, Hepatocellular Liver neoplasms Carcinoma Liver Neoplasms Digestive System Diseases |
Ethiodized Oil Gastrointestinal Neoplasms Iodine Adenocarcinoma Neoplasms, Glandular and Epithelial Hepatocellular carcinoma |
Anti-Infective Agents Anti-Infective Agents, Local Neoplasms Neoplasms by Site Neoplasms by Histologic Type Antineoplastic Agents |
Growth Substances Therapeutic Uses Physiological Effects of Drugs Trace Elements Micronutrients Pharmacologic Actions |