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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017024', 'term': 'Chemotherapy, Adjuvant'}], 'ancestors': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004358', 'term': 'Drug Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2001-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-06', 'lastUpdateSubmitDate': '2013-09-19', 'studyFirstSubmitDate': '2001-12-07', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2013-09-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence-free survival'}], 'secondaryOutcomes': [{'measure': 'Overall survival'}]}, 'conditionsModule': {'keywords': ['localized resectable adult primary liver cancer', 'adult primary hepatocellular carcinoma'], 'conditions': ['Liver Cancer']}, 'descriptionModule': {'briefSummary': '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.\n\nPURPOSE: Randomized phase III trial to determine the effectiveness of radioactive iodine in treating patients who have undergone surgery for liver cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* 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.\n\nOUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 2 treatment arms.\n\n* Arm I: Within 4-6 weeks after prior resection, patients receive adjuvant hepatic intra-arterial iodine I 131 lipiodol once.\n* Arm II: After prior resection, patients undergo observation. Patients are followed monthly for 1 year and then every 3 months thereafter.\n\nPROJECTED ACCRUAL: A minimum of 300 patients (150 per treatment arm) will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '17 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed primary hepatocellular carcinoma (HCC)\n* Completely resected disease with clear margins\n* No residual disease by postoperative CT scan\n* No metastatic disease\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 17 and over\n\nPerformance status:\n\n* Karnofsky 60-100%\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* WBC greater than 1,500/mm\\^3\n* Platelet count greater than 50,000/mm\\^3\n\nHepatic:\n\n* Bilirubin less than 2.92 mg/dL\n* PT less than 4 seconds over control\n\nRenal:\n\n* Creatinine less than 2.26 mg/dL\n\nOther:\n\n* No contraindication to contrast or radioactive iodine\n* No uncontrolled thyrotoxicosis\n* No other prior or concurrent malignancy\n* Not pregnant or nursing\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Not specified\n\nChemotherapy\n\n* Not specified\n\nEndocrine therapy\n\n* Not specified\n\nRadiotherapy\n\n* Not specified\n\nSurgery\n\n* See Disease Characteristics\n* Recovered from prior surgery\n\nOther\n\n* No other prior treatment for HCC'}, 'identificationModule': {'nctId': 'NCT00027768', 'briefTitle': 'Radioactive Iodine in Treating Patients Who Have Undergone Surgery for Liver Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Randomised Trial of Adjuvant Hepatic Intra-Arterial Iodine-131-Lipiodol Following Curative Resection of Hepatocellular Carcinoma', 'orgStudyIdInfo': {'id': 'CDR0000069066'}, 'secondaryIdInfos': [{'id': 'NMRC-AHCC03'}, {'id': 'EU-20128'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'adjuvant therapy', 'type': 'PROCEDURE'}, {'name': 'iodine I 131 ethiodized oil', 'type': 'RADIATION'}]}, 'contactsLocationsModule': {'locations': [{'zip': '169610', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'National Cancer Centre - Singapore', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '308433', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Tan Tock Seng Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '529889', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Changi General Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'overallOfficials': [{'name': 'London L. Ooi Peng Jin, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'National Cancer Centre, Singapore'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Medical Research Council (NMRC), Singapore', 'class': 'OTHER_GOV'}}}}