protocolSection identificationModule nctId: NCT06349278, orgStudyIdInfo id: 2024-7276, briefTitle: Pancreatic Cancer and Synchronous Liver Metastases Resection Following Neoadjuvant FOLFIRINOX, acronym: PDAC-LIV, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-16, primaryCompletionDateStruct date: 2026-01-16, completionDateStruct date: 2029-01-16, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Laval University, class: OTHER, descriptionModule 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., conditionsModule conditions: Pancreas Adenocarcinoma, conditions: Pancreas Metastases, conditions: Pancreas Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: One group will undergo intervention prospectively., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: Pancreatic resection and non-anatomic liver resections., outcomesModule primaryOutcomes measure: Morbidity and mortality, secondaryOutcomes measure: Overall survival, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHU de Québec, status: RECRUITING, city: Quebec City, state: Quebec, zip: G1R 2J6, country: Canada, contacts name: Alexandre Brind'Amour, role: CONTACT, phone: +14185254444, phoneExt: 15925, email: godonco@chudequebec.ca, contacts name: Jean-François Ouellet, MD, role: SUB_INVESTIGATOR, contacts name: Jean-François Berthin Ouellet, MD, role: SUB_INVESTIGATOR, contacts name: Isabelle Deshaies, MD, role: SUB_INVESTIGATOR, contacts name: Carl Daigle, MD, role: SUB_INVESTIGATOR, contacts name: Félix Couture, MD, role: SUB_INVESTIGATOR, contacts name: Maxime Chénard-Poirier, MD, role: SUB_INVESTIGATOR, contacts name: Anne-Julie Simard, role: SUB_INVESTIGATOR, geoPoint lat: 46.81228, lon: -71.21454, hasResults: False