NCT05083247

Preoperative mFOLFIRINOX (or Gem-Nab-P) +/- Isotoxic High-dose SBRT for Borderline Resectable Pancreatic Adenocarcinoma

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 256 (estimated)
• Sponsor: Erasme University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 19.9) is performed. Non-progressive patients will be randomised (1:1) 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 patient's condition precludes it.

Conditions

• Pancreatic Neoplasm
• Pancreatic Adenocarcinoma
• Borderline Resectable Pancreatic Adenocarcinoma

Interventions

Type	Name	Description
DRUG	mFOLFIRINOX or Gemcitabine nab-paclitaxel	oxaliplatin IV, irinotecan IV, leucovorin IV and 5-FU IV OR Gemcitabine IV Nab paclitaxel
RADIATION	Isotoxic High-Dose (iHD)-SBRT	Radiation therapy
PROCEDURE	Surgery	Surgery

Timeline

• Start date: 2023-03-24
• Primary completion: 2027-12-31
• Completion: 2030-12-31
• First posted: 2021-10-19
• Last updated: 2023-05-23

Locations

10 sites across 1 country: Belgium