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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: t
View:

• 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

• R0/ R1 resection

• Age ≥ 18 years

• Written informed consent

Locations
Other Locations
Italy
Fondazione Poliambulanza
RECRUITING
Brescia
Contact Information
Primary
Moh'd Abu Hilal, MD, PhD
abuhilal9@gmail.com
+393756326711
Backup
Bas Uijterwijk
basuijterwijk@live.nl
0640380827
Time Frame
Start Date: 2023-07-01
Estimated Completion Date: 2029-07-01
Participants
Target number of participants: 400
Treatments
Intestinal-type ampullary adenocarcinoma intervention
This cohort consist of patients with intestinal-type ampullary adenocarcinoma who are able to receive adjuvant chemotherapy.
Intestinal-type ampullary adenocarcinoma control
This cohort consist of patients with intestinal-type ampullary adenocarcinoma who are able to receive adjuvant chemotherapy but due to logistics or patient preference, are not willing to receive adjuvant chemotherapy.
Pancreatobiliary/mixed-type ampullary adenocarcinoma intervention
This cohort consist of patients with Pancreatobiliary/mixed-type ampullary adenocarcinoma who are able to receive adjuvant chemotherapy.
Pancreatobiliary/mixed-type ampullary adenocarcinoma control
This cohort consist of patients with Pancreatobiliary/mixed-type ampullary adenocarcinoma who are able to receive adjuvant chemotherapy but due to logistics or patient preference, are not willing to receive adjuvant chemotherapy.
Related Therapeutic Areas
Sponsors
Leads: Fondazione Poliambulanza Istituto Ospedaliero
Collaborators: Associazione Italiana per la Ricerca sul Cancro

This content was sourced from clinicaltrials.gov