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

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ClinicalTrials.gov Identifier: NCT04933435
Recruitment Status : Recruiting
First Posted : June 21, 2021
Last Update Posted : August 12, 2022
Sponsor:
Information provided by (Responsible Party):
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 Intervention/treatment Phase
Liver Cancer Other: Quality of life questionnaires Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 78 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
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 : November 12, 2020
Estimated Primary Completion Date : November 2025
Estimated Study Completion Date : November 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: X-Rays

Arm Intervention/treatment
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.
Other: Quality of life questionnaires
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)

Active Comparator: Hypofractionated Image-Guided Radiation Therapy (HIGRT)
HIGRT is a non-invasive, outpatient procedure typically delivered in 3-10 fractions of radiation.
Other: Quality of life questionnaires
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 Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04933435


Contacts
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Contact: Taylor Fryman (919) 668-3726 Taylor.Fryman@duke.edu
Contact: Joan Cahill, BNS OCN CCRP (919) 681-5200 Joan.Cahill@duke.edu

Locations
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United States, North Carolina
Durham Veterans Administration Health Care System (DVAHCS) Recruiting
Durham, North Carolina, United States, 27705
Contact: Josephine Gaston, BSN RN       Josephine.Gaston@va.gov   
Principal Investigator: Manisha Palta, MD         
Duke Cancer Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Taylor Fryman    919-668-3726    Taylor.Fryman@duke.edu   
Principal Investigator: Manisha Palta, MD         
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Manisha Palta, MD Duke Health
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT04933435    
Other Study ID Numbers: Pro00089525_1
First Posted: June 21, 2021    Key Record Dates
Last Update Posted: August 12, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases