Using organoids to predict efficacy of adjuvant treatment to improve outcome in resectable pancreatic cancer (UNITEPANC)

Patients with functionally resectable pancreatic ductal adenocarcinoma (PDAC) according to NCCN criteria and Ca19-9 <500 U/ml (without relevant cholestasis)

Trial part I: Feasibility of treatment selection by an organoid-based approach in the adjuvant setting within 12 weeks after surgery in more than 60% of the resected PDAC., Trial part II: DFS at 18 months from start of organoid-based adjuvant treatment.

Trial part I: Organoid establishment in more than 75% of the resected PDAC, Trial part I: Organoid expansion and characterization in more than 60% of the resected PDAC, Trial part I: Rate of organoid-based change of adjuvant treatment regimen from standard mFOLFIRINOX treatment, Trial part I: Comparison of organoid establishment, expansion and characterization as well as treatment outcome between the different sites establishing organoids, Trial part II: Time from surgery to start of adjuvant treatment, Trial part II: Rate of patients receiving adjuvant treatment, Trial part II: DFS in organoid-based treatment selection with and without mFOLFIRINOX, Trial part II: OS in organoid-based treatment selection with and without mFOLFIRINOX, Trial part II: Comparison of DFS and OS by organoid-based adjuvant treatment with historical controls from the PRODIGE 24 trial, Trial part II: Correlation of CT imaging (radiomics) with R0 resection rate, DFS, OS, Ca19-9 and biomarker behaviour, Trial part II: Health related quality of life (EORTC QLQ-PAN26, QLQ-C30 questionnaires), Trial part II: Safety and Toxicity of organoid-based adjuvant treatment

Germany