44
Participants
Start Date
May 31, 2006
Primary Completion Date
May 29, 2009
Study Completion Date
January 30, 2013
Induction Therapy - Capecitabine
Two 21-day cycles will be given as induction. Capecitabine will be given at 1000 mg/m2 twice daily approximately 12 hours apart for 14 days, followed by seven days off.
Induction Therapy - Oxaliplatin
Two 21-day cycles will be given as induction. Oxaliplatin will be given at 70 mg/m2 intravenously in 5% dextrose over two hours on days 1 and 8 of each cycle.
Combination Therapy - Capecitabine
Two 21-day cycles will be given for combination therapy. Capecitabine will be given at 825 mg/m2 twice daily approximately 12 hours apart for five days (Monday through Friday) followed by two days off for 51/2 weeks.
Combination Therapy - Oxaliplatin
Two 21-day cycles will be given. Oxaliplatin will be given at 50 mg/m2 intravenously in 5% dextrose over two hours on days 1, 8 and 15 of each cycle.
Combination Therapy - Radiation
1.8 Gy daily Monday through Friday to a total of 50.4 Gy for 6 weeks during combination therapy.
Evaluation for response and surgery
Four to eight weeks following the completion of therapy subjects will undergo evaluation for response and surgical resection.
Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago
Northwestern University
OTHER