ADAPTA study

Adjuvant chemotherAPy after curative intent resecTion of Ampullary Cancer

  • Chief
  • Coordinators
  • Steering committee
  • Mohammad Abu Hilal
  • Bas Uijterwijk
  • Daniel H.L. Lemmer
  • Alberto Zaniboni
  • Michele Milelle 
  • Michele Ghidini 
  • Hanneke Wilmink 
  • Aldo Scarpa 
  • Clarissa Ferrari 
  • Marc G. Besselink
  • Sara Cherri

Ampullary adenocarcinoma (AAC) is a rare form of gastrointestinal cancer, accounting for approximately 0.2% to 0.5% of all gastrointestinal cancers and 7% of all periampullary cancers. The five-year overall survival (OS) for AAC ranges between 30% and 70%, with the pancreatobiliary (PB) subtype believed to exhibit the most aggressive biological behavior. To date, no randomized trials have confirmed a survival improvement after adjuvant chemotherapy for AAC.

Recent retrospective studies have demonstrated that only patients with the PB and mixed subtypes benefit from adjuvant therapy, showing improved median overall survival, whereas no benefit was observed for the intestinal subtype. Although there is evidence of survival improvement with adjuvant treatment for AAC based on histopathological subtype, prospective studies are needed to confirm this. Additionally, the PB and mixed subtypes exhibit the worst five-year OS and the most aggressive biological behavior. A phase II study demonstrated that the combination of Capecitabine and Oxaliplatin (CAPOX) is well-tolerated and results in superior response rates and longer OS compared to other regimens in patients with AAC (all subtypes) and duodenal cancer.

Based on these findings, we hypothesize that patients with the intestinal subtype of AAC will benefit from adjuvant treatment with CAPOX, while those with the PB and mixed subtypes will benefit from adjuvant treatment with FOLFIRINOX, the preferred adjuvant treatment in pancreatic cancer. In this prospective cohort study, the authors aim to investigate whether this adjuvant treatment strategy, based on the histopathological subtypes of AAC, will result in improved survival. The study will also conduct molecular sub-studies on the histopathological subtypes of AAC to gain more knowledge about the biological behavior of this rare disease.

ADAPTA design
Double arm, non-randomized, prospective cohort, retrospectively validated, design

Patient criteria for inclusion in ADAPTA
Inclusion criteria: 
18>, curative intent, WHO 0/1, able to receive ACT
Exclusion criteria: R2, M1, Radiotherapy, pregnancy, ACT started >12w
Sample size: >100 amp.IT, >100 amp.PB, >100 control. 

 

Endpoints:
3- and 5-year Overall Survival and Disease-free Survival 
safety and tolerability
QOL
Correlations with molecular markers

The Genetic Substudy.
Some of the ADAPTA participating centers also participate in the ADAPTA Genetic Substudy. In this substudy, a slice of the tumor will be sent to the Verona Genome Laboratory to evaluate the entire clinical cancer genome of the tumor, aiming for a more profound understanding of the tumor’s pathophysiology.

Interested in participation? CONTACT US!

ISGACAconsortium@gmail.com
Abuhilal9@gmail.com
basuijterwijk@live.nl