NCT04933435NARecruiting
Interventional Radiology Liver Directed Therapies and Hypofractionated Image-Guided Radiation Therapy in Veteran and Non-Veteran, Non-surgical Hepatocellular Carcinoma Patients
Duke University
Start Date
11/12/2020
Completion Date
2/1/2027
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 Criteria
Age Range: 18 years to No maximum
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
Interventions
OTHER
Quality of life questionnaires
Conditions
Liver Cancer
Locations
Durham Veterans Administration Health Care System (DVAHCS)
Durham, North Carolina 27705
United States
Duke Cancer Center
Durham, North Carolina 27710
United States