About this trial
Ampullary adenocarcinoma (AAC) is a rare gastrointestinal cancer with varying survival rates, particularly the aggressive pancreatobiliary (PB) subtype. Adjuvant therapy benefits only PB and mixed subtype patients, while prospective studies are required for validation. A study proposes tailored adjuvant treatments (CAPOX for intestinal subtype, FOLFIRINOX for PB and mixed subtypes) based on histopathology to enhance survival, also exploring molecular sub-studies for deeper insights.
Eligibility criteria
Qualifiers
Adult patients with histologically or cytologically confirmed AAC with subtyping of pancreatobiliary/mixed subtype or intestinal subtype
After curative resection for ampullary cancer without metastatic disease.
WHO performance status 0 or 1
Able and willing to receive adjuvant chemotherapy
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Folfirinox
- Capox
Treatment groups
Sponsors and collaborators
Fondazione Poliambulanza Istituto Ospedaliero
Lead sponsor
Associazione Italiana per la Ricerca sul Cancro
Collaborator