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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

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

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

NCT ID

NCT04933435

First Posted

June 17, 2021

Last Updated

July 3, 2023

Sponsor

Duke University

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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

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

Taylor.Fryman@duke.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Joan Cahill, BNS OCN CCRP

Phone

(919) 668-5211

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

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

Taylor.Fryman@duke.edu

First Name & Middle Initial & Last Name & Degree

Manisha Palta, MD

12. IPD Sharing Statement

Plan to Share IPD

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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