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

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT04933435
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Quality of life questionnaires — OTHER
    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)

Study Details

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.

Key Dates

Start date
Nov 12, 2020
Status verified
Nov 2025
Primary completion
Feb 28, 2027
Completion
Feb 28, 2027

Study Design

Enrollment
78 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

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

Primary Outcome 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 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Duke Cancer CenterDurhamNorth Carolina27710
Heather Franklin
[email protected]
919-668-3726
Manisha Palta, MD (PRINCIPAL_INVESTIGATOR)
Durham Veterans Administration Health Care System (DVAHCS)DurhamNorth Carolina27705
Josephine Gaston, BSN RN
[email protected]
Manisha Palta, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Durham, NC

By condition
Liver cancer
By specialty
OncologyGI oncologyHepatology
By research site
Duke Cancer Center· Durham, NCDurham Veterans Administration Health Care System (DVAHCS)· Durham, NC

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