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

Study acronym: STEREOPAC
StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Start date changed from estimate of Mar 15, 2023 to Mar 24, 2023
    • Site details revised at 6 of 10 sites
    v3
  2. Trial status: Not Yet Recruiting to Recruitingv2 Show 12 more changesShow less
    • Primary completion date: Dec 31, 2023 to Dec 31, 2027
    • Start date: Nov 1, 2021 to Mar 15, 2023
    • Primary endpoints: 1 to 2
    • Enrollment target: 174 to 256
    • Study sites: 1 to 10
    • Study completion date: Dec 31, 2025 to Dec 31, 2030
    • Interventions: mFOLFIRINOX or gemcitabine-nabpaclitaxel (Drug) to Isotoxic High-Dose (iHD)-SBRT (Radiation), Surgery (Procedure), mFOLFIRINOX or Gemcitabine nab-paclitaxel (Drug)
    • Eligibility criteria shortened, about 37 words
    • Secondary endpoints: 4 to 12
    • Study description shortened, about 195 words
    • Collaborators: 7 to 3
    • Publications: 1 to 4
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05083247
Lead Sponsor Erasme University Hospital
Collaborators: Jules Bordet Institute, Belgian Group of Digestive Oncology, University Hospital St Luc, Brussels
Conditions
(from sponsor)		 Pancreatic Neoplasm, Pancreatic Adenocarcinoma, Borderline Resectable Pancreatic Adenocarcinoma
Related terms Pancreatic Neoplasms
Enrollment 256 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov