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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

Primary Purpose

Liver Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Quality of life questionnaires
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Liver Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Durham Veterans Administration Health Care System (DVAHCS)Recruiting
  • Duke Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Interventional Radiology Liver Directed Therapies (ILDT)

Hypofractionated Image-Guided Radiation Therapy (HIGRT)

Arm Description

ILDT includes ablations such as microwave ablation and percutaneous local ablation and embolotherapies including bland embolization, chemoembolization and radioembolization.

HIGRT is a non-invasive, outpatient procedure typically delivered in 3-10 fractions of radiation.

Outcomes

Primary Outcome Measures

change in quality of life in patient cohorts receiving either Interventional Radiology Liver Directed Therapies or Hypofractionated Image-Guided Radiation Therapy
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

change in quality of life in patients receiving Interventional Radiology Liver Directed Therapies or HIGRT
as measured by the FACT-Hep survey questionnaire from not at all (better) to very much (worse)
number of patients with grade ≥2 acute toxicity that received Interventional Liver Directed Therapy
number of patients with grade ≥2 acute toxicity that received Hypofractionated Image Guided Radiation Therapy
total healthcare system cost associated with Interventional Radiology Liver Directed Therapies
total healthcare system cost associated with Hypofractionated Liver Directed Therapy

Full Information

First Posted
June 17, 2021
Last Updated
July 3, 2023
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT04933435
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 12, 2020 (Actual)
Primary Completion Date
November 2025 (Anticipated)
Study Completion Date
November 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
78 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Interventional Radiology Liver Directed Therapies (ILDT)
Arm Type
Active Comparator
Arm Description
ILDT includes ablations such as microwave ablation and percutaneous local ablation and embolotherapies including bland embolization, chemoembolization and radioembolization.
Arm Title
Hypofractionated Image-Guided Radiation Therapy (HIGRT)
Arm Type
Active Comparator
Arm Description
HIGRT is a non-invasive, outpatient procedure typically delivered in 3-10 fractions of radiation.
Intervention Type
Other
Intervention Name(s)
Quality of life questionnaires
Intervention Description
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 Measure Information:
Title
change in quality of life in patient cohorts receiving either Interventional Radiology Liver Directed Therapies or Hypofractionated Image-Guided Radiation Therapy
Description
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)
Time Frame
baseline, 1 month, 3 months, 6 months
Secondary Outcome Measure Information:
Title
change in quality of life in patients receiving Interventional Radiology Liver Directed Therapies or HIGRT
Description
as measured by the FACT-Hep survey questionnaire from not at all (better) to very much (worse)
Time Frame
baseline, 1 month, 3 months, 6 months
Title
number of patients with grade ≥2 acute toxicity that received Interventional Liver Directed Therapy
Time Frame
90 days
Title
number of patients with grade ≥2 acute toxicity that received Hypofractionated Image Guided Radiation Therapy
Time Frame
90 days
Title
total healthcare system cost associated with Interventional Radiology Liver Directed Therapies
Time Frame
90 days
Title
total healthcare system cost associated with Hypofractionated Liver Directed Therapy
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Taylor Fryman
Phone
(919) 668-3726
Email
Taylor.Fryman@duke.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Joan Cahill, BNS OCN CCRP
Phone
(919) 668-5211
Email
Joan.Cahill@duke.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manisha Palta, MD
Organizational Affiliation
Duke Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Durham Veterans Administration Health Care System (DVAHCS)
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Josephine Gaston, BSN RN
Email
Josephine.Gaston@va.gov
First Name & Middle Initial & Last Name & Degree
Manisha Palta, MD
Facility Name
Duke Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Taylor Fryman
Phone
919-668-3726
Email
Taylor.Fryman@duke.edu
First Name & Middle Initial & Last Name & Degree
Manisha Palta, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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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