Conditions: Colorectal Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1886
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: Participants were given one of two regimens (each participating center prespecified which regimen they would use for all patients at that center): i) Mayo Clinic regimen group: LV 20 mg/m\^2 IV bolus injection + 5-FU 425 mg/m\^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or; ii) Roswell Park regimen group: LV 500 mg/m\^2 by two-hour IV infusion + 5-FU 500 mg/m\^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks). arm 2: Capecitabine was administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine was administered orally at a dose of 1000 mg/m\^2 twice-daily (equivalent to a total daily dose of 2000 mg/m\^2) with the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m\^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks).

Interventions: intervention 1: Capecitabine intervention 2: Oxaliplatin intervention 3: Leucovorin (LV) intervention 4: 5-Fluorouracil (5-FU)
Intervention descriptions: intervention 1: 1000 milligrams per square metre of body surface area (mg/m\^2) orally twice daily on days 1-15 of each 3-week cycle. intervention 2: 130 mg/m\^2 intravenous (IV) infusion over two hours on Day 1 of each 3-week cycle. intervention 3: Administered by one of two regimens, as specified in the arm description. intervention 4: Administered by one of two regimens, as specified in the arm description.

Protocol document: