The ADAPTA Study: ADjuvant chemotherAPy After Curative Intent resecTion of Ampullary Cancer.

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.