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

Duke University

Status: Enrolling

Conditions: Liver Cancer

Treatments: Other: Quality of life questionnaires

Study type: Interventional

Funder types: Other

Identifiers

NCT04933435

Pro00089525_1

Details and patient eligibility

About

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.

Enrollment: 78 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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78 participants in 2 patient groups

Interventional Radiology Liver Directed Therapies (ILDT)

Active Comparator group

Description:

ILDT includes ablations such as microwave ablation and percutaneous local ablation and embolotherapies including bland embolization, chemoembolization and radioembolization.

Treatment:

Other: Quality of life questionnaires

Hypofractionated Image-Guided Radiation Therapy (HIGRT)

Active Comparator group

Description:

HIGRT is a non-invasive, outpatient procedure typically delivered in 3-10 fractions of radiation.

Treatment:

Other: Quality of life questionnaires