PREOPANC-4 Implementation Program for Locally Advanced Pancreatic Cancer

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Implementation - International best-practice care

    Other intervention

    The 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

223 Participants
are divided into 1 treatment group
Group A: Implementation cohort1 intervention

Trial outcomes

Primary outcomes

1

Resection rate

Resection rate of the pancreatic tumor

Time frame
Immediately after completing the inclusion period (December 31, 2024).
2

Overall survival (OS)

OS from time of resection (mOS, 1-year OS \& 5-year OS)

Time frame
After completing the follow-up period (December 31, 2029)
3

In-hospital mortality

Mortality after resection (during primary hospitalization)

Time frame
Yearly assessment throughout the inclusion period
4

In-hospital major morbidity

Clavien-Dindo grade IIIa or higher major morbidity after resection (during primary hospitalization)

Time frame
Yearly assessment throughout the inclusion period

Secondary outcomes

1

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.

Time frame
Immediately after completing the inclusion period (December 31, 2024).
2

Quality of life

EORTC QLQ-C30: global health status Outcome measures will be calculated, according to the validated questionnaire manuals.

Time frame
Measured at 3, 6, 9, 12, 18, and 24 months from diagnosis, followed by yearly measurements.
3

Shared decision-making: patients' healthcare satisfaction

APECC decision-making self-efficacy scale. Outcome measures will be calculated, according to the validated questionnaire manuals.

Time frame
Measured at 3, 6, 9, 12, 18, and 24 months from diagnosis, followed by yearly measurements.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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