Liver CancerNCT04933435
Interventional Radiology Liver Directed Therapies and Hypofractionated Image-Guided Radiation Therapy in Veteran and Non-Veteran, Non-surgical Hepatocellular Carcinoma Patients
A study testing Quality of life questionnaires in people with Liver Cancer and Hepatocellular Carcinoma (HCC), run by Duke University at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cancer, Hepatocellular Carcinoma (HCC)
- What is being tested?
- Quality of life questionnaires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Nov 2020to Feb 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Linda Kaltenbach, PhD contact
United States2 sites, 2 recruiting
- Recruiting
Durham Veterans Administration Health Care System (DVAHCS)
Durham, North Carolina, 27705
Josephine Gaston, BSN RN, Josephine.Gaston@va.gov
Joseph Salama, MD
- Recruiting
Duke Cancer Center
Durham, North Carolina, 27710
Heather Franklin, (919) 668-3726, heather.mccullough@duke.edu
Manisha Palta, MD
About this study
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
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.
- Conditions
- Liver Cancer, Hepatocellular Carcinoma (HCC)
- Being tested
- Quality of life questionnaires
- Keywords
- Percutaneous local ablation (PLA), Hypofractionated Image-Guided Radiation Therapy (HIGRT)
- Medical subject headings
- Liver Neoplasms, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Quality of life questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
as measured by the FACT-Hep survey questionnaire from not at all (better) to very much (worse)
Measured: baseline, 1 month, 3 months, 6 months
number of patients with grade ≥2 acute toxicity that received Interventional Liver Directed Therapy
Measured: 90 days
number of patients with grade ≥2 acute toxicity that received Hypofractionated Image Guided Radiation Therapy
Measured: 90 days
total healthcare system cost associated with Interventional Radiology Liver Directed Therapies
Measured: 90 days
total healthcare system cost associated with Hypofractionated Liver Directed Therapy
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2021
- Study start12 Nov 2020
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manisha Palta, MD, Principal investigator, Duke Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04933435
- Sponsor's protocol ID
- Pro00089525_1
- Status last verified
- Oct 2026
- First submitted
- 17 Jun 2021
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No