26
Participants
Start Date
March 31, 1997
Primary Completion Date
May 31, 2006
Study Completion Date
January 31, 2007
cisplatin
Cisplatin will be given at a dose of 100 mg/m2 at a concentration of 1 mg/ml over one hour on Day 1 and 29 for a total of 2 courses
fluorouracil
5-FU will be given at 500 mg/m2 in 1 liter D5 1/2 by continuous infusion every 12 hours for a total of 8 doses (Total 1.0 g/m2/day X 4 days) on Days 1-4 and 29-32 for a total of 2 courses
paclitaxel
30 mg/m2 - 45 mg/m2 given weekly. The dose each subject receives will depend on when they enter the study
surgical procedure
Surgical resection should take place approximately 4 weeks following completion of the chemotherapy.
radiation therapy
The dose of radiation to the tumor and nodal area will be 4500 cGy given as 180 cGy fractions daily, Monday through Friday, for 5 weeks
Lineberger Comprehensive Cancer Center, UNC, Chapel Hill
National Cancer Institute (NCI)
NIH
UNC Lineberger Comprehensive Cancer Center
OTHER