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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
North Carolina
Duke Cancer Center
RECRUITING
Durham
Durham Veterans Administration Health Care System (DVAHCS)
RECRUITING
Durham
Contact Information
Primary
Heather Franklin
heather.mccullough@duke.edu
(919) 668-3726
Backup
Linda Kaltenbach, PhD
Linda.Kaltenbach@duke.edu
Time Frame
Start Date: 2020-11-12
Estimated Completion Date: 2027-02
Participants
Target number of participants: 78
Treatments
Active_comparator: Interventional Radiology Liver Directed Therapies (ILDT)
ILDT includes ablations such as microwave ablation and percutaneous local ablation and embolotherapies including bland embolization, chemoembolization and radioembolization.
Active_comparator: Hypofractionated Image-Guided Radiation Therapy (HIGRT)
HIGRT is a non-invasive, outpatient procedure typically delivered in 3-10 fractions of radiation.
Related Therapeutic Areas
Sponsors
Leads: Duke University

This content was sourced from clinicaltrials.gov