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

Description

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.

Conditions

Liver Cancer

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Liver Cancer
Intervention / Treatment

-

Contacts and Locations

Durham

Durham Veterans Administration Health Care System (DVAHCS), Durham, North Carolina, United States, 27705

Durham

Duke Cancer Center, Durham, North Carolina, United States, 27710

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Duke University,

Manisha Palta, MD, PRINCIPAL_INVESTIGATOR, Duke Health

Study Record Dates

2025-11