Advancing Treatment for Head and Neck Cancer Patients with Competing Health Risks through Multi-Center Randomized Trials - PROJECT SUMMARY ABSTRACT Head and neck cancer is a major cause of morbidity and mortality worldwide. My clinical research program focuses on novel alternative therapeutic strategies for head and neck cancer patients who are medically unfit for standard treatment, which differentially affects older populations with comorbidities and medically underserved populations. Historically, these patients have been poorly represented in clinical trials. I have dedicated my career to advancing care of head and neck cancer patients through clinical research, and have served as national PI, national co-chair, and co-author for multiple NCTN trials, as well as contact PI for NRG Oncology at UCSD. I have also led multiple funded IITs, previously holding numerous NIH grants including KL2, R21, and R01 grants supporting my clinical trials work. Recently, our field has seen a consistent string of failures of experimental arms in high-profile trials, highlighting the need for continued work to define the standard of care and develop new therapeutic strategies through NCI-sponsored trials. This project will advance science in this arena through my activities as a national leader in NRG Oncology and as Co-Chair of the NCI Head and Neck Steering Committee (HNSC), including the active development of the NRG HN2437 Phase II Randomized Trial concept. In addition, through my roles as NRG Contact PI and MCC Head and Neck Disease Team Co-Leader at my institution, I will continue to support accrual to NCI-sponsored trials, and as a scientific collaborator and co-investigator, will actively support accrual to NCI-sponsored institutional IITs that are advancing novel treatment paradigms. This grant will additionally enable me to fulfill my ambition of proposing a Clinical Trials Planning Meeting addressing older patient populations and engage in mentorship of emerging investigators. Lastly, it will enable me to continue implementing novel risk-assessment methods that I have developed, using competing event models to define subpopulations who selectively benefit from intensive treatment. For over 16 years, I have served as a research leader at UCSD's Moores Cancer Center (MCC), where I have been Head and Neck and Radiation Disease Team Leader and have led its NRG program since 2008 from affiliate to full voting member status. MCC is the only NCI-designated Comprehensive Cancer Center serving San Diego and Imperial Counties in Southern California. Its clinical trials program is the principal locus of clinical cancer research in the region, which serves a large, ethnically diverse population, with a high prevalence of underrepresented minorities and non-English speaking patients. This grant will also enable me to support innovative collaborations at UCSD, resulting in novel therapeutic strategies. Ultimately, this project will promote novel clinical trials that will improve outcomes for head and neck cancer patients with contraindications to standard therapy, defining new standards of care for future generations.
