PRODIGE 98 : Randomized, Multicenter Phase 3 Trial of Adjuvant Chemotherapy With Modified FOLFIRINOX Versus Capecitabine or Gemcitabine in Patients With Resected Ampullary Adenocarcinoma

Inclusion Criteria: * Histologically proven adenocarcinoma on surgical specimen * Macroscopically complete surgical resection of an ampullary adenocarcinoma (R0 or R1) * Adenocarcinoma removed within 12 weeks prior to enrollment * Patients ≥ 18 years of age * Patient without metastatic disease on CT scan \< 4 weeks prior to inclusion * WHO performance status 0 or 1 (WHO 0 if age \>75) * Normal values of kalemia, magnesemia and calcemiaPatient able to understand and sign the information and informed consent note * Women of childbearing age and men who are sexually active with women of childbearing age must agree to use highly effective contraception during the trial treatment at least until 6 months after the end of experimental treatment. Women of childbearing potential must use highly effective contraception at least 9 months after the end of treatment with oxaliplatin * Patient affiliated to a social security scheme for France, or equivalents in European countries * CA19.9 level \< 180 U/L at inclusion (post-operative level) Exclusion Criteria: * Neoadjuvant systemic chemotherapy * pT1N0M0 tumors * Active infection by HBV, HCV or HIV * Dihydropyrimidine dehydrogenase deficiency (uracilemia ≥ 16 ng/mL) * Pre-existing peripheral neuropathy (grade ≥ 2) * Unresolved or uncontrolled concomitant medical conditions * Neutrophils \< 1500/mm3, platelets \< 150 000/mm3, Haemoglobin \< 9 g/dL * Total bilirubin \> 1.5x normal, * Creatinine clearance \< 50 ml/min according to MDRD * …