IXO (Irinotecan, Xeloda, Oxaliplatin) in Rectal Cancer

Inclusion Criteria: General * Pathologically confirmed rectal adenocarcinoma * T3 or T4 or N1 (node ≥1 cm on short axis) adenocarcinoma of the rectum. * ECOG performance status equal or less than 1 * Male and female patients, aged ≥ 18 years and ≤ 80 years * Written informed consent * Adequate haematological, liver, renal function Resectability * Patients categorized as having resectable locally advanced cancer * Favorable general condition Exclusion Criteria: Resectability * Diagnosis of metastatic disease * Clear indication of involvement of pelvic wall(s), on imaging. * Peritoneal carcinomatosis, portal vein occlusion, ascites, non-regional lymph nodes * Histology other than adenocarcinoma * Obstructed rectal carcinoma without defunctionalizing colostomy Prior treatment * Previously undergone treatment for this disease * Prior chemotherapy for colorectal cancer * Prior chemotherapy for other malignancies in past 12 months * Prior radiotherapy other than skin cancer * Concomitant use of St John's Wort * Treatment with any other investigational agent * Current use of full-dose of warfarin for therapeutic Other conditions * Confirmed or suspected brain metastases * History or evidence of CNS disease * Past or current history of other malignancies * Clinically significant cardiovascular disease * Evidence of bleeding diathesis or coagulopathy * Known hypersensitivity to any of the study drugs * Serious, non-healing wound, ulcer or bone fracture * Major surgical procedure or significant traumatic injury within 28 days prior to treatment * Disease or condition that contraindicates the use of an investigational drug * Life expectancy less than 5 years * Inability or unwillingness to comply with the protocol * Neuropathy ≥ Gr.2 * History of ulcerative colitis or Crohn's disease * Pelvic abscess or perforated pelvic carcinoma Pregnancy / Contraception * Pregnancy or lactation * Positive serum pregnancy test within 7 days of starting study treatment