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Brief Title: Chemo-embolization for Head and Neck Cancer
Official Title: Chemo-embolization for Head and Neck Cancer
Study ID: NCT04595981
Brief Summary: The study will evaluate whether adjuvant chemo-embolization increases progression free and/or overall survival relative to standard of care radiation and chemo- and/or immunotherapy in cisplatin-ineligible head and neck cancer patients with an acceptable morbidity rate.
Detailed Description: This is a single site, single arm Phase II trial pilot study to explore if chemo-embolization increases progression free and/or overall survival in a subpopulation of cisplatin-ineligible head and neck cancer patients with an acceptable morbidity rate in the U.S. Chemo-embolization will serve as adjuvant therapy performed in addition to standard of care radiation and chemo- and/or immunotherapy. Within UAB, the Investigators plan to recruit 48 patients to implement the intervention, within a two-year period. Progression free survival will be assessed at 3, 6 and 24 months (if available) after intervention, which is determined based upon the results of follow-up Head and Neck imaging (CT or MRI) interpreted by a Radiologist not involved in the study, per standard of care. Overall survival will be reported by the patients' Oncology team on a monthly basis. The trial endpoints will form the basis of how PFS and OS compare to historical outcomes in a similar cohort of patients.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Alabama at Birmingham, Birmingham, Alabama, United States
Name: Jesse Jones, MD
Affiliation: The University of Alabama at Birmingham
Role: PRINCIPAL_INVESTIGATOR