Clinical Trials /

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

NCT04933435

Description:

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.

Related Conditions:
  • Hepatocellular Carcinoma
Recruiting Status:

Recruiting

Phase:

N/A

URL:

https://clinicaltrials.gov/show/NCT04933435

Trial Eligibility

Document

Title

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

  • ORG STUDY ID: Pro00089525_1
  • NCT ID: NCT04933435

Conditions

  • Liver Cancer

Purpose

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.

Trial Arms

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

      Eligibility Criteria

              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
      Maximum Eligible Age:N/A
      Minimum Eligible Age:18 Years
      Eligible Gender:All
      Healthy Volunteers:No

      Primary Outcome Measures

      Measure:change in quality of life in patient cohorts receiving either Interventional Radiology Liver Directed Therapies or Hypofractionated Image-Guided Radiation Therapy
      Time Frame:baseline, 1 month, 3 months, 6 months
      Safety Issue:
      Description:as defined by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC C-30)

      Secondary Outcome Measures

      Measure:change in quality of life in patients receiving Interventional Radiology Liver Directed Therapies or HIGRT
      Time Frame:baseline, 1 month, 3 months, 6 months
      Safety Issue:
      Description:as measured by the FACT-Hep survey questionnaire
      Measure:number of patients with grade ≥2 acute toxicity that received Interventional Liver Directed Therapy
      Time Frame:90 days
      Safety Issue:
      Description:
      Measure:number of patients with grade ≥2 acute toxicity that received Hypofractionated Image Guided Radiation Therapy
      Time Frame:90 days
      Safety Issue:
      Description:
      Measure:total healthcare system cost associated with Interventional Radiology Liver Directed Therapies
      Time Frame:90 days
      Safety Issue:
      Description:
      Measure:total healthcare system cost associated with Hypofractionated Liver Directed Therapy
      Time Frame:90 days
      Safety Issue:
      Description:

      Details

      Phase:N/A
      Primary Purpose:Interventional
      Overall Status:Recruiting
      Lead Sponsor:Duke University

      Last Updated

      June 21, 2021