NCT06068023

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

The ADAPTA Study: ADjuvant chemotherAPy After Curative Intent resecTion of Ampullary Cancer. A Pan-European Prospective Multicenter Double Single Arm Cohort Study.

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 400 (estimated)
• Sponsor: Fondazione Poliambulanza Istituto Ospedaliero · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

Background: Ampullary adenocarcinoma(AAC) is rare. 5-year survival rates of 30% to 70% are seen after resection. This broad range of survival could be explained by the morphological heterogeneity in the three subtypes of AAC (pancreatobiliary, intestinal and mixed subtype), which complicates the prediction of individual prognosis and clinical decision making with regard to adjuvant therapy. To date there are no prospective studies to elucidate whether adjuvant chemotherapy improves survival in these patients. Methods/design: The ADAPTA study is a phase II prospective single arm multicenter cohort study including 200 patients with resected AAC (100 patients with intestinal subtype, and 100 with pancreatobiliary- and mixed subtype). All patients will be treated with CAPOX/ FOLFIRINOX respectively. Outcomes will be compared after propensity score matching to data of all patients in consecutive participating centers not treated according to the proposed regime.

Conditions

• Ampullary Adenocarcinoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-07-01
• Primary completion: 2028-07-01
• Completion: 2029-07-01
• First posted: 2023-10-05
• Last updated: 2023-10-05

Locations

1 site across 1 country: Italy

Regulatory

• FDA-regulated drug study