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

RecruitingOBSERVATIONAL
Enrollment

400

Participants

Timeline

Start Date

July 1, 2023

Primary Completion Date

July 1, 2028

Study Completion Date

July 1, 2029

Conditions
Ampullary Adenocarcinoma
Interventions
DRUG

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."

DRUG

Capox

or 8 CAPOX cycles (Arm 1) every 3 weeks.

Trial Locations (1)

25124

RECRUITING

Fondazione Poliambulanza, Brescia

All Listed Sponsors
collaborator

Associazione Italiana per la Ricerca sul Cancro

OTHER

lead

Fondazione Poliambulanza Istituto Ospedaliero

OTHER