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Pancreatic Cancer and Synchronous Liver Metastases Resection Following Neoadjuvant FOLFIRINOX

RecruitingNAAges 18 Years - anyAllLaval University
NCT06349278 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This is a prospective, pilot study from a single center. Patients will be evaluated and operated on by one of five surgeons with a subspeciality in hepato-biliary and pancreatic surgery. After thorough, standard of care assessment for both pancreatic primary and liver metastases resectability with blood tumor markers (CEA, CA 19-9 and CA-125), triphasic CT-scan and liver magnetic resonance imaging (MRI), patients with resectable pancreatic ductal adenocarcinoma primary and three or less resectable liver metastases will be prospectively included in the study. PET-scan may be added to the investigation depending on CT-scan or MRI results to prove metastatic disease or rule out extrahepatic metastases. Patients will receive a total of 12 cycles of perioperative FOLFIRINOX (FFX), with first reassessment with triphasic CT-scan to monitor tumor response after the first six cycles. Every patien

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
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What it tests

  • Pancreatic resection and non-anatomic liver resections.
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Where

1 site
CHU de Québec
Québec, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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