Evaluating liver cancer treatments and their impact on quality of life
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 study is testing how two different liver cancer treatments affect the quality of life for patients with hepatocellular carcinoma.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 78 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Durham, North Carolina and 1 other locations) |
| Trial ID | NCT04933435 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the change in quality of life for patients with hepatocellular carcinoma (HCC) undergoing either Interventional Radiology Liver Directed Therapies or Hypofractionated Image-Guided Radiation Therapy. Participants will complete the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC C-30) to measure their quality of life from baseline to one month post-treatment. The study includes both veteran and non-veteran patients, focusing on those with specific eligibility criteria related to their liver cancer diagnosis and treatment options.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older diagnosed with hepatocellular carcinoma who meet specific clinical criteria.
Not a fit: Patients with advanced liver disease (Child Pugh score B9 or Class C) or those receiving concurrent systemic therapy for HCC may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into how different liver cancer treatments affect patients' quality of life.
How similar studies have performed: Other studies have explored similar treatment approaches for liver cancer, but this specific combination of therapies and focus on quality of life is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Durham, North Carolina and 1 other locations
- Durham Veterans Administration Health Care System (DVAHCS) — Durham, North Carolina, United States (Recruiting)
- Duke Cancer Center — Durham, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Manisha Palta, MD — Duke Health
- Study coordinator: Heather Franklin
- Email: heather.mccullough@duke.edu
- Phone: (919) 668-3726
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.