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

Not Applicable

Recruiting

• Conditions: Liver Cancer
• Interventions: Other: Quality of life questionnaires

• Registration Number: NCT04933435
• Lead Sponsor: Duke University

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-11-12
• Study First Submitted: 2021-06-17
• Study First Submitted QC: 2021-06-17
• Study First Posted: 2021-06-21
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-18
• Last Update Posted: 2024-06-21
• Primary Completion: 2025-11
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 78

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interventional Radiology Liver Directed Therapies (ILDT)	Quality of life questionnaires	ILDT includes ablations such as microwave ablation and percutaneous local ablation and embolotherapies including bland embolization, chemoembolization and radioembolization.
Hypofractionated Image-Guided Radiation Therapy (HIGRT)	Quality of life questionnaires	HIGRT is a non-invasive, outpatient procedure typically delivered in 3-10 fractions of radiation.

Primary Outcome Measures

Name	Time	Method
change in quality of life in patient cohorts receiving either Interventional Radiology Liver Directed Therapies or Hypofractionated Image-Guided Radiation Therapy	baseline, 1 month, 3 months, 6 months	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)

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Durham Veterans Administration Health Care System (DVAHCS); 🇺🇸 Durham, North Carolina, United States

Duke Cancer Center; 🇺🇸 Durham, North Carolina, United States