Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Radiation Therapy Oncology Group
With
OBJECTIVES: Primary * To determine whether substitution of cisplatin with cetuximab will result in comparable 5-year overall survival. Secondary * 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 QOL 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. * 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 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 human papilloma virus (HPV)-specific cellular immune responses measured at baseline and three months with overall or progression-free survival. OUTLINE: This is a multicenter study. Patients are stratified according to T stage (T1-2 vs T 3-4), N stage (N0-2a vs N2b-3), Zubrod performance status (0 vs 1), and smoking history (≤ 10 pack-years vs \> 10 pack-years). Patients are randomized to 1 of 2 treatment arms. Patients may complete quality-of-life questionnaires and risk factors for head and neck cancer surveys at baseline, periodically during study, and at follow-up for 1 year. After completion of study therapy, patients are followed up at 1-3 months, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
Age
18–120
Sex
ALL
Healthy volunteers
Not accepted
