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

"mFOLFIRINOX every 2 weeks during 12 cycles (24 weeks):~* Oxaliplatin 85 mg/m²~* Irinotecan 150 mg/m²~* Leucovorin 400 mg/m²~* Fluorouracil 2400 mg/m² during 46 hours"

"investigator's choice:~* Capecitabine 1250 mg/m² BID, 2 weeks on, 1 week off during 8 cycles (24 weeks) OR~* Gemcitabine 1000 mg/m² in 30 min; 3 weeks on, 1 week of, during 6 cycles ((24 weeks)"

Before treatment, during treatment (every 12 weeks in any treatment arm Until disease progression or end of follow-up) and after treatment discontinuation (30 days after the end of treatment)

Before each course of treatment and between courses of treatment if necessary

Every 3 months