Interventional Radiology Liver Directed Therapies and Hypofractionated Image-Guided Radiation Therapy in Veteran and Non-Veteran, Non-surgical Hepatocellular Carcinoma Patients
NCT ID: NCT04933435
Last Updated: 2025-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
78 participants
INTERVENTIONAL
2020-11-12
2027-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Interventional Radiology Liver Directed Therapies (ILDT)
ILDT includes ablations such as microwave ablation and percutaneous local ablation and embolotherapies including bland embolization, chemoembolization and radioembolization.
Quality of life questionnaires
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)
Hypofractionated Image-Guided Radiation Therapy (HIGRT)
HIGRT is a non-invasive, outpatient procedure typically delivered in 3-10 fractions of radiation.
Quality of life questionnaires
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)
Interventions
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Quality of life questionnaires
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)
Eligibility Criteria
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Inclusion Criteria
* Patient is 18 years or older
* ECOG Performance status of 0-2
* Child Pugh score A5, A6, B7 or B8 (see Appendix)
* Lesion ≤ 5cm in size
* ≤ 3 lesions in the liver to be treated on protocol
* Lesion amenable to treatment with both Interventional Radiology Liver Directed Therapies and HIGRT.
Exclusion Criteria
* Fluctuating ascites
* Inability to complete baseline Quality of Life survey forms
* Concurrent administration of systemic therapy for hepatocellular carcinoma
* Prior liver radiation therapy is an exclusion unless subject participation is approved by the PI
18 Years
ALL
No
Sponsors
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Duke University
OTHER
Responsible Party
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Principal Investigators
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Manisha Palta, MD
Role: PRINCIPAL_INVESTIGATOR
Duke Health
Locations
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Durham Veterans Administration Health Care System (DVAHCS)
Durham, North Carolina, United States
Duke Cancer Center
Durham, North Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Pro00089525_1
Identifier Type: -
Identifier Source: org_study_id
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