Bi-daily tegafur-uracil (UFT) plus leucovorin (LV) versus capecitabine as first-line therapy in elderly patients with advanced colorectal cancer, unfit or unwilling to receive combination chemotherapy. - A randomized, open-label phase III study -

Interventions: Arm A: UFT 300 mg/m2 orally, divided in two daily doses, days 1-28 Leucovorin: 60 mg/day orally, divided in two daily doses, days 1-28, Q5 weeks, until disease progression or unacceptable toxicity Arm B: Capecitabine 2500 mg/m2 orally,divided in two daily doses, days 1-14 Q3 weeks, until disease progression or unacceptable toxicity Primary outcome(s): Comparison of progression free survival Study Design: Randomized controlled trial, Open (masking not used), Active, Parallel