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NCT04933435 | RECRUITING | Liver Cancer

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

Condition or disease

Liver Cancer

Intervention/treatment

Quality of life questionnaires

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 78 participants
Masking : NONE
Primary Purpose : SUPPORTIVE_CARE
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
Actual Study Start Date : 2020-11-12
Estimated Primary Completion Date : 2027-02
Estimated Study Completion Date : 2027-02

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Interventional Radiology Liver Directed Therapies and Hypofractionated Image-Guided Radiation Therapy in Veteran and Non-Veteran, Non-surgical Hepatocellular Carcinoma Patients

Location Details

NCT04933435

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, North Carolina

Durham Veterans Administration Health Care System (DVAHCS)

Durham, North Carolina, United States, 27705

RECRUITING

United States, North Carolina

Duke Cancer Center

Durham, North Carolina, United States, 27710