This phase II trial compares how well percutaneous local ablation or hypofractionated image-guided radiation therapy works in improving quality of life in participants with liver cancer. Percutaneous ablation works by inserting special needles into the liver tumor and using microwaves or radiowaves to damage tumor cells in a way that may cause cell death. Hypofractionated image-guided radiation therapy is a type of external radiation therapy where beams of radiation enter the liver from multiple angles to treat the liver cancer over several treatment sessions and may cause less damage to nearby healthy tissue. It is not yet known whether percutaneous local ablation or stereotactic body radiation therapy works better in improving the quality of life in participants with liver cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04933435.
Locations matching your search criteria
United States
North Carolina
Durham
Duke University Medical CenterStatus: Active
Contact: Brian Gary Czito
Phone: 919-668-7336
PRIMARY OBJECTIVES:
I. To compare change in quality of life (QOL), 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 patients receiving percutaneous local ablation (PLA) vs hypofractionated image-guided radiation therapy (HIGRT).
SECONDARY OBJECTIVES:
I. To estimate the difference in change in QOL in patients receiving PLA vs HIGRT, as measured EORTC C-30, from baseline to 3 months post-treatment.
II. To estimate the difference in change in QOL in patients receiving PLA vs HIGRT, as measured EORTC C-30, from baseline to 6 months post-treatment.
III. To estimate the difference in change in QOL in patients receiving PLA vs HIGRT, as measured by Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep), from baseline to 1 month, baseline to 3 months and baseline to 6 months post-treatment.
IV. To assess for grade >= 2 acute toxicity within 90 days of treatment initiation.
V. To estimate the total healthcare system cost associated with PLA vs HIGRT from time of intervention through 90 days post treatment.
EXPLORATORY OBJECTIVES:
I. To assess for grade 3+ late toxicity (> 90 days post ablative therapy or radiation therapy).
II. To evaluate local control at the treated site within the liver.
III. To evaluate distant liver recurrence (intrahepatic lesions other than treated lesion).
IV. To evaluate median progression free survival (PFS).
V. To evaluate median overall survival (OS).
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants undergo HIGRT over 5 fractions for 2 weeks or 10 fractions for 3 weeks in the absence of disease progression or unacceptable toxicity.
ARM II: Participants undergo a single treatment of PLA.
After completion of study treatment, participants are followed up at 180 days and every 6 months through year 3, annually for 5 years from randomization, and then periodically.
Lead OrganizationDuke University Medical Center
Principal InvestigatorBrian Gary Czito
