Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2026-01-04 @ 9:01 AM
Study NCT ID:
NCT00238160
Status:
WITHDRAWN
Last Update Posted:
2013-05-30
First Post:
2005-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surgery With or Without Hepatic Arterial Chemotherapy in Treating Patients With Liver Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D017024', 'term': 'Chemotherapy, Adjuvant'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}], 'ancestors': [{'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-07', 'lastUpdateSubmitDate': '2013-05-29', 'studyFirstSubmitDate': '2005-10-12', 'studyFirstSubmitQcDate': '2005-10-12', 'lastUpdatePostDateStruct': {'date': '2013-05-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-10-13', 'type': 'ESTIMATED'}}, 'conditionsModule': {'conditions': ['Localized Resectable Adult Primary Liver Cancer', 'Stage III Childhood Liver Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy, such as fluorouracil and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving drugs directly into the arteries around the tumor may kill more tumor cells. Giving chemotherapy after surgery may kill any remaining tumor cells. It is not yet known whether surgery and hepatic arterial chemotherapy are more effective than surgery alone in treating patients with liver cancer that has spread to the portal vein.\n\nPURPOSE: This randomized phase III trial is studying surgery and hepatic arterial chemotherapy to see how well they work compared to surgery alone in treating patients with liver cancer that has spread to the portal vein.', 'detailedDescription': 'OBJECTIVES:\n\n* Compare the efficacy of surgical resection with vs without postoperative hepatic arterial chemotherapy in patients with hepatocellular carcinoma and portal vein tumor thrombus.\n\nOUTLINE: This is a randomized, multicenter study. Patients are stratified according to grade of portal invasion and Child-Pugh classification. Patients are randomized to 1 of 2 treatment arms.\n\n* Arm I: Patients undergo macroscopic curative resection. Within 28 days after surgery, patients without post-surgery complications undergo hepatic arterial infusion comprising fluorouracil and cisplatin on days 1-5, 8-12, and 15-19. Treatment continues for 6 months.\n* Arm II: Patients undergo macroscopic curative resection.\n\nPROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed hepatocellular carcinoma (HCC) with portal vein tumor thrombus\n* Tumor thrombus in the main trunk or first branch of the portal vein\n* No apparent distant metastases on chest CT scan and bone scintigraphy within the past 6 weeks\n* No pleural effusion or ascites\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* Not specified\n\nPerformance status\n\n* ECOG 0-1\n\nLife expectancy\n\n* Not specified\n\nHematopoietic\n\n* Neutrophil count \\> 1,000/mm\\^3\n* Platelet count \\> 50,000/mm\\^3\n* Hemoglobin \\> 8 g/dL\n\nHepatic\n\n* Bilirubin \\< 2 times upper limit of normal (ULN)\n* ALT and AST \\< 4 times ULN\n\nRenal\n\n* Creatinine normal\n\nCardiovascular\n\n* No severe heart disease\n* No cardiac effusion\n\nOther\n\n* No other malignant disease\n* No high risk for esophageal varices rupture\n* No allergy to fluorouracil or cisplatin\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Not specified\n\nChemotherapy\n\n* No prior hepatic arterial chemotherapy\n* No prior systemic chemotherapy for HCC\n\nEndocrine therapy\n\n* Not specified\n\nRadiotherapy\n\n* Not specified\n\nSurgery\n\n* Not specified'}, 'identificationModule': {'nctId': 'NCT00238160', 'briefTitle': 'Surgery With or Without Hepatic Arterial Chemotherapy in Treating Patients With Liver Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Phase III Randomized Study of Surgical Resection With Versus Without Postoperative Hepatic Arterial Chemotherapy in Patients With Hepatocellular Carcinoma and Portal Vein Tumor Thrombus', 'orgStudyIdInfo': {'id': 'KYUH-UHA-HCC02-01'}, 'secondaryIdInfos': [{'id': 'CDR0000363800', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'cisplatin', 'type': 'DRUG'}, {'name': 'fluorouracil', 'type': 'DRUG'}, {'name': 'adjuvant therapy', 'type': 'PROCEDURE'}, {'name': 'chemotherapy', 'type': 'PROCEDURE'}, {'name': 'conventional surgery', 'type': 'PROCEDURE'}, {'name': 'hepatic arterial infusion', 'type': 'PROCEDURE'}, {'name': 'surgery', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '602-8566', 'city': 'Kyoto', 'country': 'Japan', 'facility': 'Kyoto Prefectural University of Medicine', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}, {'zip': '604-8845', 'city': 'Kyoto', 'country': 'Japan', 'facility': 'Kyoto City Hospital', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}, {'zip': '606-8501', 'city': 'Kyoto', 'country': 'Japan', 'facility': 'Kyoto University Hospital', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}, {'zip': '615-8256', 'city': 'Kyoto', 'country': 'Japan', 'facility': 'Kyoto-Katsura Hospital', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}], 'overallOfficials': [{'name': 'Iwao Ikai, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Kyoto University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kyoto University', 'class': 'OTHER'}}}}