RECRUITING

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

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2020-11-12
Study Completion:2025-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04933435

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * Patient is 18 years or older
  3. * ECOG Performance status of 0-2
  4. * Child Pugh score A5, A6, B7 or B8 (see Appendix)
  5. * Lesion ≤ 5cm in size
  6. * ≤ 3 lesions in the liver to be treated on protocol
  7. * Lesion amenable to treatment with both Interventional Radiology Liver Directed Therapies and HIGRT.
  1. * Child Pugh score B9 or Class C
  2. * Fluctuating ascites
  3. * Inability to complete baseline Quality of Life survey forms
  4. * Concurrent administration of systemic therapy for hepatocellular carcinoma
  5. * Prior liver radiation therapy is an exclusion unless subject participation is approved by the PI

Contacts and Locations

Study Contact

Taylor Fryman
CONTACT
(919) 668-3726
Taylor.Fryman@duke.edu
Joan Cahill, BNS OCN CCRP
CONTACT
(919) 668-5211
Joan.Cahill@duke.edu

Principal Investigator

Manisha Palta, MD
PRINCIPAL_INVESTIGATOR
Duke Health

Study Locations (Sites)

Durham Veterans Administration Health Care System (DVAHCS)
Durham, North Carolina, 27705
United States
Duke Cancer Center
Durham, North Carolina, 27710
United States

Collaborators and Investigators

Sponsor: Duke University

  • Manisha Palta, MD, PRINCIPAL_INVESTIGATOR, Duke Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-11-12
Study Completion Date2025-11

Study Record Updates

Study Start Date2020-11-12
Study Completion Date2025-11

Terms related to this study

Additional Relevant MeSH Terms

  • Liver Cancer