The ADAPTA Study: ADjuvant chemotherAPy After Curative Intent resecTion of Ampullary Cancer.

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorFondazione Poliambulanza Istituto Ospedaliero

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

400 Participants
are divided into 4 treatment groups

Sponsors and collaborators

Fondazione Poliambulanza Istituto Ospedaliero

Lead sponsor

Associazione Italiana per la Ricerca sul Cancro

Collaborator