Titre Pancreatic Cancer and Synchronous Liver Metastases Resection Following Neoadjuvant FOLFIRINOX: a Prospective, Pilot Study
Protocole ID PDAC-LIV)
ClinicalTrials.gov ID NCT06349278
Type(s) de cancer Pancréas
Phase Autres
Type étude Clinique
Institution CHU DE QUEBEC – UNIVERSITE LAVAL
   HOPITAL DE L'ENFANT-JESUS
      1401 18e Rue, Québec, QC, G1J 1Z4
Ville Québec
Investigateur(trice) principal(e) Dr Alexandre Brind’Amour
Coordonnateur(trice) Maryse Gingras
 418-525-4444 poste 67322
Statut Actif en recrutement
Date d'activation 16-01-2024
Critètes d'éligibilité
  • Confirmed diagnosis of pancreatic ductal adenocarcinoma (PDAC).
  • Resectable primary tumor based on triphasic CT-scan.
  • ≤ 3 liver metastases.
  • Liver resections can be performed by local excision or non-anatomical, partial hepatectomy. Patients with complete radiologic response after neoadjuvant FOLFIRINOX (FFX), therefore not requiring liver resection, will be included.
  • No evidence of extrahepatic metastases.
  • Patient fit for pancreatic resection (ECOG 0 or 1).
  • Stable or partial response on imaging after neoadjuvant FFX.
  • No new metastasis after neoadjuvant FFX
  • Blood tumor markers ≥ 80% decreased or within normal values after neoadjuvant FFX.
Critètes d'exclusion
  • Impossibility to obtain tissue diagnosis preoperatively confirming PDAC.
  • Locally advanced disease on triphasic CT-scan.
  • > 3 liver metastases.
  • Major hepatectomy required for liver metastases (right hepatectomy, left hepatectomy, central hepatectomy, extended right or left hepatectomy).
  • Suspicion or confirmation of extrahepatic metastases.
  • Patient unfit for pancreatic resection (ECOG 2 or more).
  • Contraindication to receive FFX.