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A Randomized Phase II Trial for Patients With p16 Positive, Non-Smoking Associated, Locoregionally Advanced Oropharyngeal Cancer

Primary Objective To select the arm(s) achieving a 2-year progression-free survival rate of greater than or equal to 85% without unacceptable swallowing toxicity at 1 year Secondary Objectives (5/24/16) To determine patterns of failure (locoregional relapse versus distant) and survival (overall and progression-free) at 6 months and 2 years; To determine acute toxicity profiles at the end of radiation therapy and at 1 and 6 months; To determine late toxicity profiles at 1 and 2 years; To determine patient-reported swallowing outcomes at 6 months and 1 and 2 years; To determine the predictive value of 12-14 week, post-treatment FDG-PET/CT for locoregional control and PFS at 2 years; To determine the predictive value of blood and tissue biomarkers for disease outcomes at 2 years; To determine swallowing recovery per videofluoroscopy imaging at 2 years.

Primary Objective To select the arm(s) achieving a 2-year progression-free survival rate of greater than or equal to 85% without unacceptable swallowing toxicity at 1 year Secondary Objectives (5/24/16) To determine patterns of failure (locoregional relapse versus distant) and survival (overall and progression-free) at 6 months and 2 years; To determine acute toxicity profiles at the end of radiation therapy and at 1 and 6 months; To determine late toxicity profiles at 1 and 2 years; To determine patient-reported swallowing outcomes at 6 months and 1 and 2 years; To determine the predictive value of 12-14 week, post-treatment FDG-PET/CT for locoregional control and PFS at 2 years; To determine the predictive value of blood and tissue biomarkers for disease outcomes at 2 years; To determine swallowing recovery per videofluoroscopy imaging at 2 years.