58
Participants
Start Date
January 31, 2004
Primary Completion Date
January 31, 2016
Study Completion Date
January 31, 2016
5-Fluorouracil
"2.2 Gm/m\^2 By Vein Over 48 Hours On Days 1, 15, 29, and 43.~Chemoradiotherapy: 300 mg/m2 a day Monday through Friday, by continuous infusion during radiation through an outpatient portable pump."
Folinic Acid
200 mg/m\^2 by vein Over 30 Minutes On Days 1, 15, 29, and 43.
Oxaliplatin
"100 mg/m\^2 By Vein Over 2 Hours On Days 1, 15, 29, and 43.~Chemoradiotherapy: 45 mg/m\^2 over 2 hours weekly for 5 weeks during radiation. (oxaliplatin should be administered on the first day of the radiation week)."
Radiotherapy
45 Gy (1.8 Gy fx/day) Monday through Friday, 12 days after the last dose of 5FU plus oxaliplatin and no later than 28 days.
Surgery
4-6 weeks after completion of chemoradiotherapy, restaged \& surgical resection of the primary tumor and lymph nodes attempted.
University of Texas MD Anderson Cancer Center, Houston
Collaborators (1)
Sanofi-Synthelabo
INDUSTRY
M.D. Anderson Cancer Center
OTHER