Clinical Research Directory

Inclusion Criteria: * Adult patients with histologically or cytologically confirmed AAC with subtyping of pancreatobiliary/mixed subtype or intestinal subtype * After curative resection for ampullary cancer without metastatic disease. * WHO performance status 0 or 1 * Able and willing to receive adjuvant chemotherapy * R0/ R1 resection * Age ≥ 18 years * Written informed consent Exclusion Criteria: * Prior radiotherapy, chemotherapy, or resection for AAC. * Previous malignancy (excluding non-melanoma skin cancer), unless no evidence of disease and diagnosed more than 5 years before diagnosis of AAC. * Pregnancy. * R2 resection. * Adjuvant chemotherapy started more than 12 weeks after surgery (aim to start within 8 weeks) * Serious concomitant systemic disorders that would compromise the safety of the patient or his/her ability to complete the study, at the discretion of the investigator. * Known hypersensitivity or contraindications against capecitabine, 5 FU, Irinotecan, or Oxaliplatin * Inadequate organ functions, characterized by: * Leucocytes (WBC) \< 3.0 X 109/l * Neutrophils \< 1.500 (count per microliter of blood) * Platelets \< 100 x 109 /l * Hemoglobin \< 8 mmol/l * Renal function: E-GFR \< 50 ml/min (serum creatinine \< 1.5 x UNL) * cholestasis with elevated levels of bilirubin and/or alkaline phosphatase \> 3x UNL (can be improved by biliary drainage if necessary) * elevated transaminases (ALAT/ASAT) ≥ 5 x UNL * hypoalbuminemia \< 2.5 g/dl * Inadequate coagulation status INR \> 2 or Quick \< 50%, aPTT \>50 sec in the absence of any drugs interfering with coagulation such as acenocoumarin, warfarin, phenprocoumon, NMH or UFH.