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 * AST or ALT \> 2.5 x UNL, alkaline phosphatase \> 2.5x normal at least 15 days after resection * Patients with poor nutritional status represented by albuminemia \< 30.0g/dl * History of myocardial infarction within the last 6 months, severe coronary artery disease or severe heart failure * Active and/or potentially severe infection * Treatment with a strong cytochrome P450 inhibitor within 4 weeks prior to the administration of the protocol treatment (Treatment with Hypericum perforatum) * Patient under treatment by brivudine, or treated by brivudine within 4 weeks prior to beginning of study treatment * Concomitant use with St John's Wort * QT/QTc interval longer than 450msec for men and longer than 470msec for women on the ECG * Hypersensitivity to any of the study products or their excipients * Administration of live vaccines within 28 days prior to randomization * Other cancer treated within the last 5 years except adequately treated, in situ cervical carcinoma or basocellular/spinocellular carcinoma * chronic bowel disease requiring specific treatment and/or intestinal obstruction * Pregnant or breastfeeding woman * Person under guardianship * Inability to undergo the medical follow-up of the trial for geographical, social or psychological reasons