195
Participants
Start Date
December 31, 2016
Primary Completion Date
December 14, 2022
Study Completion Date
December 14, 2022
Intensity Modulated Radiotherapy (IMRT)
60- 70 Gy at 2 Gy/fx
Cisplatin (or alternative)
The acceptable weekly chemotherapy regimens are Cisplatin 30 to 40 mg/m2 (first choice), Cetuximab 250mg/m2 (second choice), Carboplatin AUC 1.5 and paclitaxel 45 mg/m2 (third choice), Carboplatin AUC 3 (fourth choice). Chemotherapy will be given intravenously weekly during IMRT, 6 -7 total doses.
Assessment for surgical evaluation
Decision for surgical evaluation will be based on the results of the PET/CT and clinical exam 10-16 weeks after CRT. Patients with a positive PET/CT scan will undergo surgical evaluation at the discretion of the surgeon. Patients with a negative PET/CT scan will be observed.
University of North Carolina at Chapel Hill, Department of Radiation Oncology, Chapel Hill
Rex Healthcare, Raleigh
University of Florida Proton Therapy Institute, Jacksonville
University of Florida, Gainesville
UNC Lineberger Comprehensive Cancer Center
OTHER