NCT04933435 Interventional Radiology Liver Directed Therapies and Hypofractionated Image-Guided Radiation Therapy in Veteran and Non-Veteran, Non-surgical Hepatocellular Carcinoma Patients
| NCT ID | NCT04933435 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Duke University |
| Condition | Liver Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 78 participants |
| Start Date | 2020-11-12 |
| Primary Completion | 2027-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 78 participants in total. It began in 2020-11-12 with a primary completion date of 2027-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Manisha Palta, MD
PRINCIPAL INVESTIGATOR
Duke Health
Frequently Asked Questions
Who can join the NCT04933435 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Liver Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04933435 currently recruiting?
Yes, NCT04933435 is actively recruiting participants. Contact the research team at heather.mccullough@duke.edu for enrollment information.
Where is the NCT04933435 trial being conducted?
This trial is being conducted at Durham, United States, Durham, United States.
Who is sponsoring the NCT04933435 clinical trial?
NCT04933435 is sponsored by Duke University. The principal investigator is Manisha Palta, MD at Duke Health. The trial plans to enroll 78 participants.
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