Ampullary adenocarcinoma (AMPAC) is a rare cancer (0.2% of digestive cancers) affecting the ampulla of Vater. The only curative treatment is surgery, but around 4% of patients recur within 2 years of surgical resection.
The aim of adjuvant chemotherapy is to reduce the risk of disease recurrence, and the only chemotherapies that can be considered standard to date are capecitabine and gemcitabine.
In this trial, an alternative experimental treatment strategy using modified FOLFORINOX (mFOLFORINOX) is proposed. It consists of 3 chemotherapies with complementary actions: 5-fluorouracil, irinotecan and oxaliplatin, combined with folic acid a vitamin that enhances the efficacy of 5-fluorouracil.
This study proposes 2 treatment schemes:
* Group A: mFOLFIRINOX: oxaliplatin, irinotecan, 5-fluorouracil, with folinic acid, * group B: mono-chemotherapy with capecitabine or gemcitabine.
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
Neoadjuvant systemic chemotherapy
pT1N0M0 tumors
Active infection by HBV, HCV or HIV
Dihydropyrimidine dehydrogenase deficiency (uracilemia ≥ 16 ng/mL)