About this trial
A prospective, nationwide, implementation program of the international standard of excellence for locally advanced pancreatic cancer (LAPC) care in the Netherlands (2021\[7\]-2030\[6\]), including a multidisciplinary training program by the four leading international expert centers.
The PREOPANC-4 project aims a safe and patient-centered implementation of the international standards of excellence for LAPC (surgery) in the Netherlands.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older
Pathology-confirmed (LAPC)*
CT-based non-progressive disease (RECIST criteria) after at least 4 months of systemic chemotherapy ([m]FOLFIRINOX / gemcitabine-nab-paclitaxel).
Disqualifiers
Metastatic pancreatic cancer prior to induction chemotherapy.
According to the Dutch Pancreatic Cancer Group (DPCG) definition: >90 degrees arterial tumor involvement (i.e. superior mesenteric artery, celiac axis, and/or hepatic artery) and/or portovenous involvement of either >270 degrees or occlusion.
Trial population
Adult patients with pathology confirmed non-metastasized LAPC and non-progressive disease after at least two months of (modified) FOLFIRINOX or gemcitabine-nab-paclitaxel induction chemotherapy and fit for major surgery.
Trial design
Cohort
Prospective
Treatments tested in this trial
Implementation - International best-practice care
Other interventionThe PREOPANC-4 project aims to safely implement the international standard of excellence for LAPC management and surgery using a multidisciplinary best-practice training program, based on the experiences of four leading international expert centers (i.e. NYU Langone Health, University of Colorado, Heidelberg University, and MD Anderson Cancer Center). We hypothesize that the PREOPANC-4 implementation project will result in the improvement in multidisciplinary patient management and selection in line with current international best-practice.
Treatment groups
Trial outcomes
Primary outcomes
Resection rate
Resection rate of the pancreatic tumor
Overall survival (OS)
OS from time of resection (mOS, 1-year OS \& 5-year OS)
In-hospital mortality
Mortality after resection (during primary hospitalization)
In-hospital major morbidity
Clavien-Dindo grade IIIa or higher major morbidity after resection (during primary hospitalization)
Secondary outcomes
R0 resection rate
R0 (microscopic radical resection \>1mm) versus R1 (microscopic residual tumor ≤1mm). NB. For the anterior margin, only direct ingrowth is considered as R1.
Quality of life
EORTC QLQ-C30: global health status Outcome measures will be calculated, according to the validated questionnaire manuals.
Shared decision-making: patients' healthcare satisfaction
APECC decision-making self-efficacy scale. Outcome measures will be calculated, according to the validated questionnaire manuals.
Sponsors and contacts
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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead sponsor
UMC Utrecht
Collaborator
Erasmus Medical Center
Collaborator
Leiden University Medical Center
Collaborator
University Medical Center Groningen
Collaborator
Radboud University Medical Center
Collaborator
Maastricht University Medical Center
Collaborator
Medisch Spectrum Twente
Collaborator
Isala
Collaborator
Frisius Medisch Centrum
Collaborator
Onze Lieve Vrouwe Gasthuis
Collaborator
Amphia ziekenhuis
Collaborator
Jeroen Bosch Ziekenhuis
Collaborator
Catharina Ziekenhuis Eindhoven
Collaborator
University of Colorado, Denver
Collaborator
Heidelberg University
Collaborator
M.D. Anderson Cancer Center
Collaborator
NYU Langone Health
Collaborator
Dutch Cancer Society
Collaborator
Maag Lever Darm Stichting
Collaborator
Deltaplan Alvleesklierkanker
Collaborator