Comparing 3 approaches for pancreatic ductal adenocarcinoma

Inclusion

• +Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
• +Participants must meet all of the following criteria prior to Pre-BaselineBaselineYour starting measurements, taken before treatment begins.Read more → registration:
• +Age 18 years or older.
• +Histological or radiological diagnosis of resectable, borderline resectable, or locally advanced PDAC.
• +Medically fit and planned to undergo laparoscopic procedure as part of standard of careStandard of careThe treatment normally given for a condition outside a study.Read more →.
• +Able to give informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → for the study-related procedures performed during laparoscopy.
• +Participants must meet all of the following criteria to be eligible for enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more → in the Main Study:
• +Age 18 years or older.
• +Enrolled in the Personalized Oncogenomics (POG) Program at BC Cancer.
• +Histological and/or radiological diagnosis of resectable, borderline resectable, or locally advanced PDAC. Participants without a histological diagnosis of PDAC must undergo confirmatory histological diagnosis prior to treatment start date.
• +Medically fit to undergo surgical resection of the primary lesion(s) as judged by the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → (Resectable and Borderline Resectable CohortsCohortA group of participants sharing a characteristic, followed together.Read more → only).
• +Planned for adjuvant (Resectable and Borderline Resectable Cohorts) or first-line (Locally Advanced Cohort) therapy with FOLFIRINOX or a gemcitabine-based regimen, either as part of routine care or in combination with an investigational agent(s) within another clinical trialInterventional studyA study where participants are given something to see what happens.Read more →. Participants may have received pre-operative therapy.
• +Adequate organ function as defined by the following laboratory results obtained within 28 days prior to enrollment date:
• +Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L.
• +Hemoglobin ≥ 9 g/dL.
• +Platelets ≥ 75 x 10\^9/L.
• +Prothrombin time test and international normalized ratio (PT/INR) and partial thromboplastin time (PTT) ≤ 1.5 x Upper Limit of Normal (ULN).
• +Total bilirubin ≤ 1.5 x ULN. Isolated bilirubin \> 1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin \< 35%.
• +Aspartate aminotransferase (AST) and alanine aminotransferase (AST) ≤ 1.5 x ULN. If liver metastases are present, AST and ALT ≤ 5 x ULN is permitted.
• +Albumin ≥ 25 g/L.
• +One of the following:
• +Creatinine ≤ 1.5 x ULN.
• +Calculated creatinine clearance (as calculated by Cockcroft-Gault formula) ≥ 40 mL/min.
• +24-hour urine creatinine clearance ≥ 40 mL/min.
• +Life expectancy greater than 90 days as judged by the investigator.
• +Able to give informed consent for the study procedures defined in this protocolProtocolThe detailed plan a study must follow.Read more →.
• +Measurable disease by RECIST 1.1. For those in the Resectable and Borderline Resectable Cohorts, measurable disease must be present prior to resection surgery.