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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Liver Cancer
• Intervention / Treatment: Other: Quality of life questionnaires

• Study Type: Interventional
• Enrollment (Estimated): 78
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joan Cahill, BNS OCN CCRP; Phone Number: (919) 668-5211; Email: Joan.Cahill@duke.edu
• Study Contact Backup: Name: Taylor Fryman; Phone Number: (919) 668-3726; Email: Taylor.Fryman@duke.edu

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Recruiting
      • Duke Cancer Center
      • Principal Investigator: Manisha Palta, MD
      • Contact: Taylor Fryman; Phone Number: 919-668-3726; Email: Taylor.Fryman@duke.edu
    • Durham, North Carolina, United States, 27705
      • Recruiting
      • Durham Veterans Administration Health Care System (DVAHCS)
      • Contact: Josephine Gaston, BSN RN; Email: Josephine.Gaston@va.gov
      • Principal Investigator: Manisha Palta, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Quality 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)
Active Comparator: Hypofractionated Image-Guided Radiation Therapy (HIGRT); HIGRT is a non-invasive, outpatient procedure typically delivered in 3-10 fractions of radiation.	Other: Quality 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	baseline, 1 month, 3 months, 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in quality of life in patients receiving Interventional Radiology Liver Directed Therapies or HIGRT	as measured by the FACT-Hep survey questionnaire from not at all (better) to very much (worse)	baseline, 1 month, 3 months, 6 months
number of patients with grade ≥2 acute toxicity that received Interventional Liver Directed Therapy		90 days
number of patients with grade ≥2 acute toxicity that received Hypofractionated Image Guided Radiation Therapy		90 days
total healthcare system cost associated with Interventional Radiology Liver Directed Therapies		90 days
total healthcare system cost associated with Hypofractionated Liver Directed Therapy		90 days

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Manisha Palta, MD, Duke Health

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2020
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: June 17, 2021
• First Submitted That Met QC Criteria: June 17, 2021
• First Posted (Actual): June 21, 2021

Study Record Updates

• Last Update Posted (Actual): July 5, 2023
• Last Update Submitted That Met QC Criteria: July 3, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma, Hepatocellular
• Other Study ID Numbers: Pro00089525_1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No