22
Participants
Start Date
May 31, 2005
Primary Completion Date
May 31, 2008
Study Completion Date
May 31, 2008
Capecitabine
"Capecitabine 1000\* mg/m2 po bid day 1-14; repeat every three weeks for two cycles~\*For calculated creatinine clearance of 30-50 mL/min or patients \> 70 years old, capecitabine starting dose is 825 mg/m2 po bid"
Irinotecan
Irinotecan 200 mg/m2 IV, day 1
EUS
biopsy per EUS
Neoadjuvant Chemotherapy
"* Irinotecan 200 mg/m2 IV, day 1~* Capecitabine 1000 mg/m2 po bid day 1-14; repeat every three weeks for two cycles"
Preoperative Radiation
Pelvic XRT 45 Gy/1.8 GY/fx/qd+5/4 Gy/1.8 Gy/fx/qd for T3+9 Gy/1.8/Gy/fx/qd for T4
Surgery
Surgery within 8 weeks following chemoradiotherapy
Adjuvant Chemotherapy
Adjuvant chemotherapy at investigator's discretion
Indiana University Cancer Center, Indianapolis
Quality Cancer Center (MCGOP), Indianapolis
Elkhart Clinic, Elkhart
Center for Cancer Care at Goshen Health System, Goshen
Northern Indiana Cancer Research Consortium, South Bend
Fort Wayne Oncology & Hematology, Inc, Fort Wayne
Center for Cancer Care, Inc., P.C., New Albany
Medical Consultants, P.C., Muncie
AP&S Clinic, Terre Haute
Collaborators (1)
Pfizer
INDUSTRY
Roche Pharma AG
INDUSTRY
Walther Cancer Institute
OTHER
Gabi Chiorean, MD
OTHER