NCT04933435 · Duke University
Interventional Radiology Liver Directed Therapies and Hypofractionated Image-Guided Radiation Therapy in Veteran and Non-Veteran, Non-surgical Hepatocellular Carcinoma Patients
What this study is about
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.
View original scientific description
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.
Interventions
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
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)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Durham, North Carolina
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 19, 2025 · Source of record for eligibility and locations