Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-30 @ 10:29 PM
Study NCT ID:
NCT04933435
Status:
RECRUITING
Last Update Posted:
2025-11-19
First Post:
2021-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interventional Radiology Liver Directed Therapies and Hypofractionated Image-Guided Radiation Therapy in Veteran and Non-Veteran, Non-surgical Hepatocellular Carcinoma Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008113', 'term': 'Liver Neoplasms'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 78}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-11-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2021-06-17', 'studyFirstSubmitQcDate': '2021-06-17', 'lastUpdatePostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in quality of life in patient cohorts receiving either Interventional Radiology Liver Directed Therapies or Hypofractionated Image-Guided Radiation Therapy', 'timeFrame': 'baseline, 1 month, 3 months, 6 months', 'description': 'as defined by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC C-30) measured from not at all (better) to very much (worse)'}], 'secondaryOutcomes': [{'measure': 'change in quality of life in patients receiving Interventional Radiology Liver Directed Therapies or HIGRT', 'timeFrame': 'baseline, 1 month, 3 months, 6 months', 'description': 'as measured by the FACT-Hep survey questionnaire from not at all (better) to very much (worse)'}, {'measure': 'number of patients with grade ≥2 acute toxicity that received Interventional Liver Directed Therapy', 'timeFrame': '90 days'}, {'measure': 'number of patients with grade ≥2 acute toxicity that received Hypofractionated Image Guided Radiation Therapy', 'timeFrame': '90 days'}, {'measure': 'total healthcare system cost associated with Interventional Radiology Liver Directed Therapies', 'timeFrame': '90 days'}, {'measure': 'total healthcare system cost associated with Hypofractionated Liver Directed Therapy', 'timeFrame': '90 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Liver Cancer']}, 'descriptionModule': {'briefSummary': 'This is a research study to evaluate change in Quality of Life, as defined by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC C-30), from baseline to 1 month post treatment in two patient cohorts receiving Interventional Radiology Liver Directed Therapies or Hypofractionated Image-Guided Radiation Therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* HCC diagnosed either by histology/pathology or Liver Imaging Reporting and Data System (LIRADs 5 per the ACR's LIRADs criteria 10) by CT or MRI\n* Patient is 18 years or older\n* ECOG Performance status of 0-2\n* Child Pugh score A5, A6, B7 or B8 (see Appendix)\n* Lesion ≤ 5cm in size\n* ≤ 3 lesions in the liver to be treated on protocol\n* Lesion amenable to treatment with both Interventional Radiology Liver Directed Therapies and HIGRT.\n\nExclusion Criteria:\n\n* Child Pugh score B9 or Class C\n* Fluctuating ascites\n* Inability to complete baseline Quality of Life survey forms\n* Concurrent administration of systemic therapy for hepatocellular carcinoma\n* Prior liver radiation therapy is an exclusion unless subject participation is approved by the PI"}, 'identificationModule': {'nctId': 'NCT04933435', 'briefTitle': 'Interventional Radiology Liver Directed Therapies and Hypofractionated Image-Guided Radiation Therapy in Veteran and Non-Veteran, Non-surgical Hepatocellular Carcinoma Patients', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Phase II Non-Randomized Trial of Interventional Radiology Liver Directed Therapies and Hypofractionated Image-Guided Radiation Therapy in Veteran and Non-Veteran, Non-surgical Hepatocellular Carcinoma Patients', 'orgStudyIdInfo': {'id': 'Pro00089525_1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Interventional Radiology Liver Directed Therapies (ILDT)', 'description': 'ILDT includes ablations such as microwave ablation and percutaneous local ablation and embolotherapies including bland embolization, chemoembolization and radioembolization.', 'interventionNames': ['Other: Quality of life questionnaires']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Hypofractionated Image-Guided Radiation Therapy (HIGRT)', 'description': 'HIGRT is a non-invasive, outpatient procedure typically delivered in 3-10 fractions of radiation.', 'interventionNames': ['Other: Quality of life questionnaires']}], 'interventions': [{'name': 'Quality of life questionnaires', 'type': 'OTHER', 'description': 'European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (QLQ-C30) and Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep)', 'armGroupLabels': ['Hypofractionated Image-Guided Radiation Therapy (HIGRT)', 'Interventional Radiology Liver Directed Therapies (ILDT)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Josephine Gaston, BSN RN', 'role': 'CONTACT', 'email': 'Josephine.Gaston@va.gov'}, {'name': 'Manisha Palta, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Durham Veterans Administration Health Care System (DVAHCS)', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Heather Franklin', 'role': 'CONTACT', 'email': 'heather.mccullough@duke.edu', 'phone': '919-668-3726'}, {'name': 'Manisha Palta, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Duke Cancer Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'centralContacts': [{'name': 'Heather Franklin', 'role': 'CONTACT', 'email': 'heather.mccullough@duke.edu', 'phone': '(919) 668-3726'}, {'name': 'Linda Kaltenbach, PhD', 'role': 'CONTACT', 'email': 'Linda.Kaltenbach@duke.edu'}], 'overallOfficials': [{'name': 'Manisha Palta, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}