nctId: NCT06349278 id: 2024-7276 briefTitle: Pancreatic Cancer and Synchronous Liver Metastases Resection Following Neoadjuvant FOLFIRINOX acronym: PDAC-LIV overallStatus: RECRUITING date: 2024-01-16 date: 2026-01-16 date: 2029-01-16 date: 2024-04-05 date: 2024-04-16 name: Laval University class: OTHER briefSummary: 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 patient will receive at least 6 cycles of FFX before surgery. The remaining six cycles will be received either preoperatively or postoperatively, depending on patient tolerance and tumor response at reassessment. Patients with liver metastases only visible on MRI will also have liver MRI at reassessment, which is also standard of care. Patients with evidence of tumor response on both imaging using RECIST V.1.1 criteria (stable disease or partial response), and blood tumor markers (≥ 80% decrease and/or normalization of all tumor markers) will then undergo pancreatic resection, either distal pancreatectomy or pancreatoduodenectomy depending on tumor side, with liver metastases excision. Each case will be followed with blood tumor markers and CT-scan every three months for two years, and every four months afterwards or until recurrence, which is standard of care for patients with metastatic PDAC. For patients without evidence of tumor response on imaging, or \< 80% decrease of all tumor markers, the standard palliative systemic treatment will be continued. conditions: Pancreas Adenocarcinoma conditions: Pancreas Metastases conditions: Pancreas Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: One group will undergo intervention prospectively. primaryPurpose: TREATMENT masking: NONE count: 15 type: ESTIMATED name: Pancreatic resection and non-anatomic liver resections. measure: Morbidity and mortality measure: Overall survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU de Québec status: RECRUITING city: Quebec City state: Quebec zip: G1R 2J6 country: Canada name: Alexandre Brind'Amour role: CONTACT phone: +14185254444 phoneExt: 15925 email: godonco@chudequebec.ca name: Jean-François Ouellet, MD role: SUB_INVESTIGATOR name: Jean-François Berthin Ouellet, MD role: SUB_INVESTIGATOR name: Isabelle Deshaies, MD role: SUB_INVESTIGATOR name: Carl Daigle, MD role: SUB_INVESTIGATOR name: Félix Couture, MD role: SUB_INVESTIGATOR name: Maxime Chénard-Poirier, MD role: SUB_INVESTIGATOR name: Anne-Julie Simard role: SUB_INVESTIGATOR lat: 46.81228 lon: -71.21454 hasResults: False