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

Liver Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04933435
• Other study ID #: Pro00089525_1
• Status: Recruiting
• Phase: N/A
• Start date: November 12, 2020
• Est. completion date: November 2025

Study information

• Verified date: June 2024
• Source: Duke University
• Contact: Taylor Fryman
• Phone: (919) 668-3726
• Email: Taylor.Fryman[@]duke.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 78
• Est. completion date: November 2025
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Liver Cancer

Intervention

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)

Locations

Country	Name	City	State
United States	Duke Cancer Center	Durham	North Carolina
United States	Durham Veterans Administration Health Care System (DVAHCS)	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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)	baseline, 1 month, 3 months, 6 months
Secondary	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
Secondary	number of patients with grade =2 acute toxicity that received Interventional Liver Directed Therapy		90 days
Secondary	number of patients with grade =2 acute toxicity that received Hypofractionated Image Guided Radiation Therapy		90 days
Secondary	total healthcare system cost associated with Interventional Radiology Liver Directed Therapies		90 days
Secondary	total healthcare system cost associated with Hypofractionated Liver Directed Therapy		90 days