PHASE II: ADAPTIVE TREATMENT DE-ESCALATION IN FAVORABLE RISK HPV-POSITIVE OROPHARYNGEAL CARCINOMA

Brief description of study

This will be a phase II single-arm clinical trial. The primary objective of this study is to evaluate progression-free survival at 2 years. The secondary objectives will include 2-year locoregional control and overall survival, quality of life, and late toxicity. Quality of life outcomes can be assessed with a validated, self-reported questionnaire. Late toxicity can be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events. Additionally, the prognostic value of positive HPV in salivary rinse as well as plasma at mid and post- treatment time points will be evaluated with a baseline evaluation pre-treatment. Radiomic analysis of pre-treatment imaging will be correlated with outcomes.


Clinical Study Identifier: s17-00330
ClinicalTrials.gov Identifier: NCT03215719
Principal Investigator: Kenneth S Hu.
Other Investigators: Elizabeth M Coffey, Paulina Galavis, Jacqueline Mojica, Elaine Shum, Christoph Maier, Janet H. Van Cleave, Michael E. Pacold, Colin Hill, Milan R Amin, Danny Perlaza, Elise M Zahriah, Nora Russo, Monica Rivera, Joshua K Sabari, Marissa Rybstein, Caitlin Elizabeth Ryan, Moses M Tam, Tuyet-Phuong N Tran, Zujun Li, Adam S Jacobson, Catherine M Concert, Ann M Riccobene.


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