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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.
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