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

Study Overview
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Brief Summary
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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
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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

Conditions
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Liver Cancer

Intervention / Treatment
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* Other: Quality of life questionnaires


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Interventional Radiology Liver Directed Therapies (ILDT)<br>ILDT includes ablations such as microwave ablation and percutaneous local ablation and embolotherapies including bland embolization, chemoembolization and radioembolization. | Other: Quality of life questionnaires<br>* 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)<br>|
| Active Comparator: Hypofractionated Image-Guided Radiation Therapy (HIGRT)<br>HIGRT is a non-invasive, outpatient procedure typically delivered in 3-10 fractions of radiation. | Other: Quality of life questionnaires<br>* 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)<br>|

What is the study measuring?
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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 |