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
Duke University
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 *…
Interventions
- OtherQuality 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)
Locations (2)
- Durham Veterans Administration Health Care System (DVAHCS)Durham, North Carolina
- Duke Cancer CenterDurham, North Carolina