45
Participants
Start Date
February 7, 2012
Primary Completion Date
November 30, 2014
Study Completion Date
November 30, 2019
Intensity Modulated Radiotherapy (IMRT)
All patients will receive IMRT. Dose painting IMRT will be used and all doses will be specified to the planning target volume (PTV). The high risk planning target volume (PTV-HR) and standard risk planning target volume (PTV-SR) will be treated to the following respective total doses: 60 Gy and 54 Gy. The dose per fraction to the PTV-HR and PTV-SR will be 2 Gy per day and 1.8 Gy per day, respectively. The PTV-HR will include the gross tumor and the PTV-SR will include the lymph nodes at risk for harboring micro-metastatic disease (i.e. subclinical disease).
Cisplatin
Cisplatin, 30mg/m2, will be given intravenously over 60 minutes weekly during IMRT; 6 total doses for a total of 180 mg/m2. It is preferred that the doses be administered on days 1, 8, 15, 22, and 29, and 36 of IMRT; however, this is not mandatory.
Limited surgical evaluation
4 to 14 weeks after completion of CRT, patients will have at least a biopsy of the primary tumor and limited neck surgery to remove those lymph nodes that were involved with cancer prior to CRT.
University of North Carolina at Chapel Hill, Department of Radiation Oncology, Chapel Hill
Rex Healthcare, Raleigh
Rex Cancer Center of Wakefield, Raleigh
Penrose Cancer Center, Colorado Springs
University of Florida, Department of Radiation Oncology, Gainesville
UNC Lineberger Comprehensive Cancer Center
OTHER