Ignite Creation Date:
2024-05-06 @ 7:35 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06068023
Status:
RECRUITING
Last Update Posted:
2023-10-05
First Post:
2023-08-29
Brief Title:
The ADAPTA Study ADjuvant chemotherAPy After Curative Intent resecTion of Ampullary Cancer
Sponsor:
Fondazione Poliambulanza Istituto Ospedaliero
Organization:
Fondazione Poliambulanza Istituto Ospedaliero
Study Overview
Official Title:
The ADAPTA Study ADjuvant chemotherAPy After Curative Intent resecTion of Ampullary Cancer A Pan-European Prospective Multicenter Double Single Arm Cohort Study
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ADAPTA
Brief 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 adenocarcinomaAAC 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
Methodsdesign
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
Ampullary adenocarcinomaAAC 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
Methodsdesign
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None