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NCT Number: NCT04933435

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

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.

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Key information

Conditions

Liver Cancer Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke Cancer Center, Durham, North Carolina, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Primary outcomes

  1. 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

    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)

Secondary outcomes

  1. change in quality of life in patients receiving Interventional Radiology Liver Directed Therapies or HIGRT

    Time frame: baseline, 1 month, 3 months, 6 months

    as measured by the FACT-Hep survey questionnaire from not at all (better) to very much (worse)

  2. number of patients with grade ≥2 acute toxicity that received Interventional Liver Directed Therapy

    Time frame: 90 days

  3. number of patients with grade ≥2 acute toxicity that received Hypofractionated Image Guided Radiation Therapy

    Time frame: 90 days

  4. total healthcare system cost associated with Interventional Radiology Liver Directed Therapies

    Time frame: 90 days

  5. total healthcare system cost associated with Hypofractionated Liver Directed Therapy

    Time frame: 90 days

Study contacts

Contact information is provided by the study sponsor or research team.

Heather Franklin

CONTACT

[email protected]

(919) 668-3726

Linda Kaltenbach, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Jun 21, 2021
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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