An Open-Label Randomized Phase III Study of Intermittent Oral Capecitabine in Combination With Intravenous Oxaliplatin (Q3W) ("XELOX") Versus Fluorouracil/Leucovorin as Adjuvant Therapy for Patients Who Have Undergone Surgery for Colon Carcinoma, AJCC/UICC Stage III (Dukes Stage C)
An Open-Label Randomized Phase III Study of Intermittent Oral Capecitabine in Combination With Intravenous Oxaliplatin (Q3W) ("XELOX") Versus Fluorouracil/Leucovorin as Adjuvant Therapy for Patients Who Have Undergone Surgery for Colon Carcinoma, AJCC/UICC Stage III (Dukes Stage C)
This 2 arm study will compare the efficacy and safety of intermittent oral Xeloda plus Eloxatin (oxaliplatin) with that of fluorouracil/leucovorin in patients who have had surgery for colon cancer and no previous chemotherapy. Patients will be randomized to receive either 1) XELOX (Xeloda 1000mg/m2 po bid on days 1-15 + oxaliplatin) in 3 week cycles or 2)5-fluorouracil + leucovorin in 4 or 8 week cycles. The anticipated time on study treatment is until disease progression and the target sample size is 500+ individuals.
Inclusion Criteria:
Exclusion Criteria:
Northridge, California 91325, United States
Whittier, California 90603, United States
Aurora, Colorado 80045, United States
Washington D.C., District of Columbia 20007, United States
Miami, Florida 33136, United States
Philadelphia, Pennsylvania 19104-4283, United States
Madison, Wisconsin 53792, United States
Toronto, Ontario M5G 2M9, Canada
Montreal, Quebec H3T 1E2, Canada
Shanghai, 200025, China
Shanghai, 200092, China
Szeged, 6720, Hungary
Udine, Friuli Venezia Giulia 33100, Italy
Genoa, Liguria 16132, Italy
Ancona, The Marches 60121, Italy
Auckland, 1023, New Zealand
Lodz, 93-509, Poland
Szczecin, 71-730, Poland
Warsaw, 02-781, Poland
Saint Petersburg, 197758, Russia
Saint Petersburg, 198255, Russia
Singapore, 119228, Singapore
Seoul, 03080, South Korea
Seoul, 133-792, South Korea
Seoul, 138-736, South Korea
Santander, Cantabria 39008, Spain
Jaén, 23007, Spain
Cambridge, CB2 2QH, United Kingdom
Glasgow, G12 0YN, United Kingdom