Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2026-02-23 @ 1:53 PM
Study NCT ID:
NCT01798160
Status:
COMPLETED
Last Update Posted:
2015-10-20
First Post:
2013-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Selective Internal Radiation Therapy (SIRT) Versus Transarterial Chemoembolisation (TACE) for the Treatment of Hepatocellular Carcinoma (HCC).
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016461', 'term': 'Chemoembolization, Therapeutic'}, {'id': 'D037761', 'term': 'Sirtuins'}], 'ancestors': [{'id': 'D004621', 'term': 'Embolization, Therapeutic'}, {'id': 'D006489', 'term': 'Hemostatic Techniques'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D060205', 'term': 'Therapeutic Occlusion'}, {'id': 'D056545', 'term': 'Group III Histone Deacetylases'}, {'id': 'D006655', 'term': 'Histone Deacetylases'}, {'id': 'D000581', 'term': 'Amidohydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D036002', 'term': 'ADP Ribose Transferases'}, {'id': 'D010430', 'term': 'Pentosyltransferases'}, {'id': 'D016695', 'term': 'Glycosyltransferases'}, {'id': 'D014166', 'term': 'Transferases'}, {'id': 'D047908', 'term': 'Intracellular Signaling Peptides and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-18', 'studyFirstSubmitDate': '2013-02-16', 'studyFirstSubmitQcDate': '2013-02-21', 'lastUpdatePostDateStruct': {'date': '2015-10-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free-Survival', 'timeFrame': 'up to three years'}, {'measure': 'Overall-Survival', 'timeFrame': 'up to three years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': 'Selective Internal Radiation Therapy is superior to Transarterial Chemoembolisation for the treatment of intermediate stage hepatocellular carcinoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥18 years\n* HCC, proven by histology or according to EASL criteria\n* Intermediate stage HCC (stage B according to BCLC)\n* At least one measurable lesion in magnetic resonance imaging (MRI)\n* Tumor load ≤ 50%\n* preserved liver function (Child Pugh A and B)\n\nExclusion Criteria:\n\n* Patients feasible for curative treatment (e.g. resection or local ablation)\n* Previous TACE or SIRT\n* Chemotherapy during the last 4 weeks\n* Child Pugh stage C\n* BCLC stage D\n* ECOG Performance Status \\>0\n* Tumor involvement \\>50% of the liver\n* Extrahepatic tumor\n* Serum Bilirubin \\>2.0 mg/dl; Serum Albumin 2.8 g/dl, Serum Creatinine \\>2 mg/dl; Leukocytes \\<3000/ml; Thrombocytes \\<50000/ml\n* Clinically apparent ascites (ascites only in CT/MRI is no exclusion criteria)\n* Esophageal bleeding during the last 3 months\n* Hepatic encephalopathy\n* Transjugular intrahepatic portosystemic shunt (TIPS)\n* Infiltration or occlusion of the portal vein\n* Hepatofugal blood flow in the portal vein\n* Hepatopulmonary shunt ≥ 20% in the macroaggregated albumin scan\n* Contraindications against angiography\n* Gravidity'}, 'identificationModule': {'nctId': 'NCT01798160', 'briefTitle': 'Selective Internal Radiation Therapy (SIRT) Versus Transarterial Chemoembolisation (TACE) for the Treatment of Hepatocellular Carcinoma (HCC).', 'organization': {'class': 'OTHER', 'fullName': 'Johannes Gutenberg University Mainz'}, 'officialTitle': 'Selective Internal Radiation Therapy (SIRT) Versus Transarterial Chemoembolisation (TACE) for the Treatment of Hepatocellular Carcinoma (HCC).', 'orgStudyIdInfo': {'id': 'SIRT-TACE-HCC-Mainz-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'DEB TACE', 'description': 'Drug eluting Beads (DC Beads) loaded with Doxorubicin', 'interventionNames': ['Procedure: DEB TACE']}, {'type': 'EXPERIMENTAL', 'label': 'SIRT', 'description': 'Selective Internal Radiation Therapy using Yttrium 90 loaded resin beads (Sir Spheres)', 'interventionNames': ['Procedure: SIRT']}], 'interventions': [{'name': 'DEB TACE', 'type': 'PROCEDURE', 'otherNames': ['Chemoembolization'], 'description': 'DEB TACE every 6 weeks until either no viable tumor or endpoint reached.', 'armGroupLabels': ['DEB TACE']}, {'name': 'SIRT', 'type': 'PROCEDURE', 'otherNames': ['Radioembolization'], 'description': 'Selective Internal Radiation Therapy once at the beginning of the study. Follow up until endpoint.', 'armGroupLabels': ['SIRT']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johannes Gutenberg University Mainz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant', 'investigatorFullName': 'Michael Bernhard Pitton', 'investigatorAffiliation': 'Johannes Gutenberg University Mainz'}}}}