Prospective randomised clinical trial phase II: 5-fluorouracil/folinic acid (5-FU/FA) and irinotecan versus combination cepecitabin and irinotecan in patients with metastatic colorectal cancer as first line treatment

Study hypothesis: There will be no statistically significant differences in efficacy, safety and survival of XELIRI regimen compared to standard FOLFIRI regimen in neoadjuvant setting of patients with unresectable liver-only metastases of colorectal cancer.
Primary outcome(s): During the therapy, the following were assessed at baseline, 3 and 6 months, thereafter follow-up was every 3 months until progression of the disease (no limit on the maximum duration of follow-up):
1. Response rate: Response Evaluation Criteria in Solid Tumors (RECIST)
2. Rate of radical surgical resection (R0 resection)