24
Participants
Start Date
July 31, 2002
Primary Completion Date
November 30, 2004
Study Completion Date
March 31, 2008
celecoxib
twice daily beginning 5 days prior to radiotherapy and continuing until completion of radiotherapy
fluorouracil
Patients receive concurrent fluorouracil IV continuously for 5 weeks.
conventional surgery
4-10 weeks after completion of chemoradiotherapy
radiation therapy
Patients undergo radiotherapy 5 days a week for 5 weeks
tumor biopsy
at baseline and then at the time of surgical resection
laboratory biomarker analysis
blood and urine collected at baseline, 5 days after initiation of celecoxib, 7 days after initiation of celecoxib in combination with fluorouracil and radiotherapy, and at the time of surgical resection. specimens are evaluated for COX-2 expression, eicosanoid production, and gene and protein expression using immunohistochemistry, microarray, and mass spectrometry.
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus, Nashville
Vanderbilt-Ingram Cancer Center, Nashville
National Cancer Institute (NCI)
NIH
Vanderbilt-Ingram Cancer Center
OTHER