Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 10:19 PM
Study NCT ID:
NCT00870558
Status:
COMPLETED
Last Update Posted:
2011-08-16
First Post:
2009-03-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Iodine I 131 Ethiodized Oil in Preventing Recurrent Cancer in Patients Who Have Undergone Treatment 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': 'D004998', 'term': 'Ethiodized Oil'}], 'ancestors': [{'id': 'D007459', 'term': 'Iodized Oil'}, {'id': 'D010938', 'term': 'Plant Oils'}, {'id': 'D009821', 'term': 'Oils'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-04', 'lastUpdateSubmitDate': '2011-08-13', 'studyFirstSubmitDate': '2009-03-26', 'studyFirstSubmitQcDate': '2009-03-26', 'lastUpdatePostDateStruct': {'date': '2011-08-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tumor recurrence at 2 years'}]}, 'conditionsModule': {'keywords': ['adult primary hepatocellular carcinoma', 'advanced adult primary liver cancer', 'localized resectable adult primary liver cancer', 'localized unresectable adult primary liver cancer'], 'conditions': ['Liver Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Iodine I 131 ethiodized oil may help prevent or delay the recurrence of cancer. It is not yet known whether iodine I 131 ethiodized oil is more effective than non-radiolabeled ethiodized oil in preventing recurrent cancer in patients who have undergone treatment for liver cancer.\n\nPURPOSE: This randomized phase III trial is studying iodine I 131 ethiodized oil to see how well it works compared with non-radiolabeled ethiodized oil in preventing recurrent cancer in patients who have undergone treatment for liver cancer.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine whether treatment with adjuvant intra-arterial iodine I 131 ethiodized oil reduces the percentage of tumor recurrence in patients with curatively treated hepatocellular carcinoma.\n\nSecondary\n\n* Evaluate the overall and recurrence-free survival of these patients.\n* Evaluate the deterioration of liver function in these patients.\n* Evaluate the toxicity of intra-arterial iodine I 131 ethiodized oil in these patients.\n\nOUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.\n\n* Arm I: Patients receive an intra-arterial infusion of iodine I 131 ethiodized oil.\n* Arm II: Patients receive an intra-arterial infusion of unlabeled ethiodized oil.\n\nAfter completion of study treatment, patients are followed periodically for 5 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Diagnosis of hepatocellular carcinoma (HCC)\n\n * Alpha-fetoprotein \\< 20 ng/mL\n* Must have undergone curative treatment for HCC within the past 8-20 weeks, including 1 of the following:\n\n * Curative resection\n * Alcohol ablation, radiofrequency ablation, or cryotherapy (for 1 or 2 nodules \\< 5 cm in diameter)\n* No ascites\n* No other intrahepatic involvement or nodule progression as assessed by ultrasound\n* No extrahepatic metastases\n\nPATIENT CHARACTERISTICS:\n\n* WHO performance status 0-2\n* ANC ≥ 1,500/mm³\n* Platelet count ≥ 50,000/mm³\n* Bilirubin ≤ 51 μmol/L\n* Creatinine ≤ 120 μmol/L\n* Not pregnant or nursing\n* Negative pregnancy test\n* Child-Pugh score \\< 8 (class B)\n* No decompensated cirrhosis\n* No encephalopathy\n* No uncontrolled bleeding\n* No portal thrombosis, right- or left-branch thrombosis, extrahepatic thrombosis, or portal reflux by doppler or CT scan\n* No unstable medical or surgical disease\n* No contraindication to vascular arteriography\n* No history of complications after injection of iodine contrast agents\n* Not incarcerated\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics\n* Recovered from all prior therapy\n* No prior hormonal treatment, including tamoxifen and somatostatin analogs\n* No prior systemic chemotherapy'}, 'identificationModule': {'nctId': 'NCT00870558', 'briefTitle': 'Iodine I 131 Ethiodized Oil in Preventing Recurrent Cancer in Patients Who Have Undergone Treatment for Liver Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Adjuvant Treatment by Intra-arterial Injection of Lipiodol-labeled Iodine-131 in Preventing Recurrence of Hepatocellular Carcinoma After Curative Treatment', 'orgStudyIdInfo': {'id': 'CDR0000626727'}, 'secondaryIdInfos': [{'id': 'HCL-2004-348-3'}, {'id': 'INCA-RECF0436'}, {'id': 'HCL-LIPIODOL'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I', 'description': 'Patients receive an intra-arterial infusion of iodine I 131 ethiodized oil.', 'interventionNames': ['Radiation: iodine I 131 ethiodized oil']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm II', 'description': 'Patients receive an intra-arterial infusion of unlabeled ethiodized oil.', 'interventionNames': ['Drug: ethiodized oil']}], 'interventions': [{'name': 'ethiodized oil', 'type': 'DRUG', 'description': 'Given as an intra-arterial infusion', 'armGroupLabels': ['Arm II']}, {'name': 'iodine I 131 ethiodized oil', 'type': 'RADIATION', 'description': 'Given as an intra-arterial infusion', 'armGroupLabels': ['Arm I']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69437', 'city': 'Lyon', 'country': 'France', 'facility': 'Hopital Edouard Herriot - Lyon', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'overallOfficials': [{'name': 'Jerome Dumortier, MD', 'affiliation': 'Hopital Edouard Herriot - Lyon'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}}}}