Ignite Creation Date:
2024-05-06 @ 4:46 PM
Last Modification Date:
2024-10-26 @ 2:15 PM
Study NCT ID:
NCT05083247
Status:
RECRUITING
Last Update Posted:
2023-05-23
First Post:
2021-09-29
Brief Title:
Preoperative mFOLFIRINOX or Gem-Nab-P - Isotoxic High-dose SBRT for Borderline Resectable Pancreatic Adenocarcinoma
Sponsor:
Erasme University Hospital
Organization:
Erasme University Hospital
Study Overview
Official Title:
Preoperative Treatment With mFOLFIRINOX or Gem-Nab-P - Isotoxic High-dose Stereotactic Body Radiation Therapy iHD-SBRT for Borderline Resectable Pancreatic Adenocarcinoma a Randomised Phase II Study STEREOPAC
Status:
RECRUITING
Status Verified Date:
2023-03
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:
STEREOPAC
Brief Summary:
Surgical resection is the only potentially curative treatment for patients with pancreatic cancer with the aim of curative R0 resection and related improvement of survival As a standard surgery is usually followed by adjuvant therapy that improves survival but neoadjuvant therapy NAT is a rapidly emerging concept that needs to be explored and validated in terms of therapeutic options in borderline resectable pancreatic tumors In this setting preoperative FFX seems to be feasible and can be prolonged by radiation therapy However the exact and best therapeutic sequence is not yet known and the additional role of adding isotoxic high-dose stereotactic body radiotherapy iHD-SBRT to chemotherapy requires validation in randomised trials We propose to evaluate the impact and efficacy of adding iHD-SBRT to preoperative neoadjuvant mFFX or Gem-NabP in patients with borderline resectable pancreatic adenocarcinoma
Detailed Description:
STEREOPAC is an multicenter academic prospective randomised comparative interventional study
Patients receive 4 cycles of mFOLFIRINOX or Gem-Nab-P A full restaging clinical morphologic imaging vascular involvement biologics CA 199 is performed Non-progressive patients will be randomised 11 to
ARM A for receiving 4 additional cycles of chemo followed by surgery
or to
ARM B for receiving 5th and 6th cycles of chemo then iHD-SBRT followed by a 7th and optional 8th cycle followed by surgery
in case of CI or intolerance to mFFX Gem-Nab-P regimen can be chosen or shifted to for 6 doses then restaging and then 3 doses followed by SBRT or 6 doses and immediate surgery
Adjuvant chemotherapy administration is indicated unless the patients condition precludes it
Patients receive 4 cycles of mFOLFIRINOX or Gem-Nab-P A full restaging clinical morphologic imaging vascular involvement biologics CA 199 is performed Non-progressive patients will be randomised 11 to
ARM A for receiving 4 additional cycles of chemo followed by surgery
or to
ARM B for receiving 5th and 6th cycles of chemo then iHD-SBRT followed by a 7th and optional 8th cycle followed by surgery
in case of CI or intolerance to mFFX Gem-Nab-P regimen can be chosen or shifted to for 6 doses then restaging and then 3 doses followed by SBRT or 6 doses and immediate surgery
Adjuvant chemotherapy administration is indicated unless the patients condition precludes it
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None