RecruitingInterventional

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

NCT ID: NCT04933435Sponsor: Duke UniversityLast updated: 2025-11-19

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.

Arms & 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)

Outcome measures

Primary

change in quality of life in patient cohorts receiving either Interventional Radiology Liver Directed Therapies or Hypofractionated Image-Guided Radiation Therapy
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)
Time frame: baseline, 1 month, 3 months, 6 months

Secondary

change in quality of life in patients receiving Interventional Radiology Liver Directed Therapies or HIGRT
Time frame: baseline, 1 month, 3 months, 6 months
number of patients with grade ≥2 acute toxicity that received Interventional Liver Directed Therapy
Time frame: 90 days
number of patients with grade ≥2 acute toxicity that received Hypofractionated Image Guided Radiation Therapy
Time frame: 90 days
total healthcare system cost associated with Interventional Radiology Liver Directed Therapies
Time frame: 90 days
total healthcare system cost associated with Hypofractionated Liver Directed Therapy
Time frame: 90 days

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy 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 * Concurrent administration of systemic therapy for hepatocellular carcinoma * Prior liver radiation therapy is an exclusion unless subject participation is approved by the PI

Study locations (2)

Durham Veterans Administration Health Care System (DVAHCS)

Durham, North Carolina, 27705

Recruiting

Josephine Gaston, BSN RN · Contact

Josephine.Gaston@va.gov

Manisha Palta, MD · Principal Investigator

Duke Cancer Center

Durham, North Carolina, 27710

Recruiting

Heather Franklin · Contact

919-668-3726 heather.mccullough@duke.edu

Manisha Palta, MD · Principal Investigator