146
Participants
Start Date
March 31, 2004
Primary Completion Date
May 31, 2011
Study Completion Date
December 31, 2016
Radiation Therapy
Pelvic radiation therapy given once daily 5 days a week for 6 weeks, 45 Gy in 25 fractions + boost of 5.4 Gy in 3 fractions for a total dose of 50.4 Gy.
Capecitabine 1650 mg/m^2/day
825 mg/m\^2 q12 hours (1650 mg/m\^2/day) orally 5 days per week during radiotherapy.
Capecitabine 1200 mg/m^2/day
600 mg/m\^2 q12 hours(1200 mg/m\^2/day) orally 5 days per week during radiotherapy.
Irinotecan
50mg/m\^2 IV over 1 hour on days 1, 8, 22, and 29
Oxaliplatin
50mg/m\^2 IV over 2 hours on days 1, 8, 15, 22, and 29
Surgery
All patients will undergo surgery four to eight weeks following the completion of radiation therapy. The choice of procedure abdominoperineal resection (APR), low anterior resection (LAR), or LAR/coloanal anastomosis is at the discretion of the surgeon.
Folinic Acid
400 mg/m\^2 IV over 2 hours Day 1 (postoperatively) ,every 14 days, for nine 14-day cycles.
Fluorouracil
"5-fluorouracil bolus 400 mg/m\^2 IV push Day 1 (postoperatively), every 14 days, for nine 14-day cycles.~5-fluorouracil infusion 2400 mg/m\^2 IV continuous infusion over 46 hours, beginning day 1, every 14 days, for nine 14-day cycles."
Oxaliplatin
85 mg/m\^2 IV over 2 hours Day 1 (postoperatively), every 14 days, for nine 14-day cycles.
Northeast Radiation Oncology Center, Dunmore
Baptist-South Miami Regional Cancer Program, Miami
Ingalls Cancer Care Center at Ingalls Memorial Hospital, Harvey
University of California Davis Cancer Center, Sacramento
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton, Marlton
National Cancer Institute (NCI)
NIH
Radiation Therapy Oncology Group
NETWORK