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Phase III Trial of Radiotherapy Plus Cetuximab Versus Chemoradiotherapy in HPV-Associated Oropharynx Cancer

Primary Objective: To determine whether substitution of cisplatin with Cetuximab will result in comparable 5-year overall survival Secondary Objectives: To monitor and compare progression-free survival for safety ; To compare patterns of failure (locoregional vs. distant); To compare acute toxicity profiles (and overall toxicity burden); To compare overall quality of life (QOL) short-term (< 6 months) and long-term (1 year) To compare quality of life Swallowing Domains short-term and long-term; To compare clinician-reported versus patient-reported CTCAE toxicity events; To explore differences in the cost effectiveness of Cetuximab as compared to cisplatin; To explore differences in work status and time to return to work; To compare patient-reported changes in hearing as measured by the HHIA-S; To compare CTCAE, v. 4 late toxicity at 1, 2, and 5 years To evaluate the effect of tobacco exposure (and other exposures) as measured by standardized computer-assisted self interview (CASI) on overall survival and progression-free survival; To pilot computer-assisted self interview (CASI) collection of patient reported outcomes in a cooperative group setting; To determine whether specific molecular profiles are associated with overall or progression-free survival; To investigate associations between changes in serum biomarkers or HPV-specific cellular immune responses measured at baseline and three months with overall or progression-free survival.



Recruitment Status

Past Studies