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Interventional Radiology Liver Directed Therapies and Hypofractionated Image-Guided Radiation Therapy in Veteran and Non-Veteran, Non-surgical Hepatocellular Carcinoma Patients

RecruitingNAAges 18 Years - anyAllDuke University
NCT04933435 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 * 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: * Child Pugh score B9 or Class C * 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
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What it tests

  • Quality of life questionnaires
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Where

2 sites
Durham Veterans Administration Health Care System (DVAHCS)
Durham, United States
Duke Cancer Center
Durham, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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