400
Participants
Start Date
July 1, 2023
Primary Completion Date
July 1, 2028
Study Completion Date
July 1, 2029
Folfirinox
"Patients meeting the criteria of post-operative adenocarcinoma of the ampulla of Vater will be enrolled, with adjuvant chemotherapy commencing within 8 weeks of recovery from surgery. Those undergoing palliative intent surgery or palliative chemotherapy are ineligible for the ADAPTA study.~The ADAPTA study's adjuvant chemotherapy involves 8-12 FOLFIRINOX cycles (Arm 2) repeated 2 weeks. Given patient outcomes, 8 cycles of FOLFIRINOX are deemed sufficient due to completion challenges in prior research. FOLFIRINOX regimen mirrors the modified version from the ACCORD/PRODIGE trial for metastatic pancreatic cancer. This trial adapts mFOLFIRINOX for standard practice."
Capox
or 8 CAPOX cycles (Arm 1) every 3 weeks.
RECRUITING
Fondazione Poliambulanza, Brescia
Associazione Italiana per la Ricerca sul Cancro
OTHER
Fondazione Poliambulanza Istituto Ospedaliero
OTHER