NCT04933435

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
9mo left

Started Nov 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress88%
Nov 2020Feb 2027

Study Start

First participant enrolled

November 12, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 17, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 21, 2021

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

November 19, 2025

Status Verified

November 1, 2025

Enrollment Period

6.2 years

First QC Date

June 17, 2021

Last Update Submit

November 18, 2025

Conditions

Liver Cancer

Outcome Measures

Primary Outcomes (1)

  • 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)

    baseline, 1 month, 3 months, 6 months

Secondary Outcomes (5)

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

    baseline, 1 month, 3 months, 6 months

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

    90 days

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

    90 days

  • total healthcare system cost associated with Interventional Radiology Liver Directed Therapies

    90 days

  • total healthcare system cost associated with Hypofractionated Liver Directed Therapy

    90 days

Study Arms (2)

Interventional Radiology Liver Directed Therapies (ILDT)

ACTIVE COMPARATOR

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

Other: Quality of life questionnaires

Hypofractionated Image-Guided Radiation Therapy (HIGRT)

ACTIVE COMPARATOR

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

Other: Quality of life questionnaires

Interventions

Quality of life questionnairesOTHER

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)

Hypofractionated Image-Guided Radiation Therapy (HIGRT)Interventional Radiology Liver Directed Therapies (ILDT)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Durham Veterans Administration Health Care System (DVAHCS)

Durham, North Carolina, 27705, United States

RECRUITING

Duke Cancer Center

Durham, North Carolina, 27710, United States

RECRUITING

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver Diseases

Study Officials

  • Manisha Palta, MD

    Duke Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Heather Franklin

CONTACT

(919) 668-3726heather.mccullough@duke.edu

Linda Kaltenbach, PhD

CONTACT

Linda.Kaltenbach@duke.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2021

First Posted

June 21, 2021

Study Start

November 12, 2020

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

November 19, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

US(2)