Trial Title:
PREOPANC-4 Implementation Program for Locally Advanced Pancreatic Cancer
NCT ID:
NCT05524090
Condition:
Pancreatic Cancer
Locally Advanced Pancreatic Adenocarcinoma
Pancreatic Adenocarcinoma Non-resectable
Chemotherapy Effect
Conditions: Official terms:
Adenocarcinoma
Pancreatic Neoplasms
Conditions: Keywords:
Nationwide implementation International Best-Practice
The Netherlands
International Best-Practice
Patient Selection
Patient-centered
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Implementation - International best-practice care
Description:
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.
Arm group label:
Implementation cohort
Summary:
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.
Detailed description:
Rationale:
Non-metastasized locally advanced pancreatic cancer (LAPC) is diagnosed in 35% of all
pancreatic cancer patients and is traditionally treated with palliative care. Recently,
the multidisciplinary management of LAPC has evolved by the introduction of modern
multi-agent induction chemotherapies, leading to an increased resection rate and improved
outlook for five-year survival. In contrast, five-year survival after chemotherapy
without surgery is virtually non-existent. In the Netherlands, the LAPC resection rate
after induction chemotherapy remains low with 8% versus 25% in international centers of
excellence, leading to missed opportunities for five-year survival in a selected subgroup
of LAPC patients. Explanations for this large difference include the spectrum of
chemotherapy use, interpretation of diagnostics, patient selection, and surgical
techniques.
Objective:
A safe and patient-centered implementation of the international standards of excellence
for LAPC (surgery) in the Netherlands.
Study design:
A prospective, nationwide, implementation program of the international standard of
excellence for LAPC care in the Netherlands (2021[7]-2030[6]), including a
multidisciplinary training program by the four leading international expert centers (i.e.
University of Heidelberg, University of Colorado, NYU Langone, and MD Anderson Cancer
Center). Subsequently, the three Dutch centers with the highest surgical volume and
documented experience in LAPC surgery will implement this highly complex LAPC surgery in
close collaboration with the other Dutch Pancreatic Cancer Group (DPCG) centers. Patients
who meet the inclusion criteria will be discussed within an online (inter)national expert
panel to properly select patient for surgery. In addition, the other DPCG centers can
present their LAPC patients to this panel for advice about (surgical) treatment options
and if these patients should be referred to the three high-volume DPCG centers for
surgery. Outcomes will be compared with a historical Dutch LAPC cohort, using propensity
score matching.
Study population:
Adult patients with pathology confirmed non-metastasized LAPC and non-progressive disease
after at least four months of (modified) FOLFIRINOX or gemcitabine-nab-paclitaxel
induction chemotherapy and fit for major surgery.
Study aim:
The primary study aim is to double the LAPC resection rate in the Netherlands from 8% to
16% with adequate survival and morbidity targets.
Primary targets:
1. Survival: After resection, mOS of 25 months, 1-year survival >90%, and 5-year
survival >20%. These outcomes will be compared to the Dutch cohort of patients
(2015-2020) with RECIST non-progressive LAPC after induction chemotherapy who did
not undergo surgical exploration;
2. In-hospital morbidity and mortality: in-hospital/30-day mortality ≤5% and
in-hospital major morbidity of <50% after resection, which will be compared with a
recent Dutch cohort (2015-2020) of resected patients with borderline resectable and
locally advanced pancreatic cancer after induction/neoadjuvant therapy.
Secondary targets:
1. Non-inferior radical resection (R0) rate as compared to a recent Dutch cohort
(2015-2020) of resected patients with borderline resectable and locally advanced
pancreatic cancer after induction/neoadjuvant therapy;
2. Non-inferior quality of life, mental and physical health status, and potential side
effects on the long-term follow-up, compared to a control cohort of Dutch LAPC
patients;
3. Non-inferior patients' healthcare satisfaction, compared to the Dutch historical
cohort of pancreatic cancer patients.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Amsterdam UMC, locatie AMC
Address:
City:
Amsterdam
Zip:
1105 AZ
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Marc G Besselink, MD, MSc, PhD
Email:
m.g.besselink@amsterdamUMC.nl
Contact backup:
Last name:
Thomas F Stoop, MD
Phone:
+316 547 555 11
Email:
t.f.stoop@amsterdamUMC.nl
Investigator:
Last name:
Marc G Besselink, MD, PhD, MSc
Email:
Principal Investigator
Start date:
July 1, 2021
Completion date:
December 31, 2030
Lead sponsor:
Agency:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Agency class:
Other
Collaborator:
Agency:
UMC Utrecht
Agency class:
Other
Collaborator:
Agency:
Erasmus Medical Center
Agency class:
Other
Collaborator:
Agency:
Leiden University Medical Center
Agency class:
Other
Collaborator:
Agency:
University Medical Center Groningen
Agency class:
Other
Collaborator:
Agency:
Radboud University Medical Center
Agency class:
Other
Collaborator:
Agency:
Maastricht University Medical Center
Agency class:
Other
Collaborator:
Agency:
Medisch Spectrum Twente
Agency class:
Other
Collaborator:
Agency:
Isala
Agency class:
Other
Collaborator:
Agency:
Medical Centre Leeuwarden
Agency class:
Other
Collaborator:
Agency:
Onze Lieve Vrouwe Gasthuis
Agency class:
Other
Collaborator:
Agency:
Amphia ziekenhuis
Agency class:
Other
Collaborator:
Agency:
Jeroen Bosch Ziekenhuis
Agency class:
Other
Collaborator:
Agency:
Catharina Ziekenhuis Eindhoven
Agency class:
Other
Collaborator:
Agency:
University of Colorado, Denver
Agency class:
Other
Collaborator:
Agency:
Heidelberg University
Agency class:
Other
Collaborator:
Agency:
M.D. Anderson Cancer Center
Agency class:
Other
Collaborator:
Agency:
NYU Langone Health
Agency class:
Other
Collaborator:
Agency:
Dutch Cancer Society
Agency class:
Other
Collaborator:
Agency:
Maag Lever Darm Stichting
Agency class:
Other
Collaborator:
Agency:
Deltaplan Alvleesklierkanker
Agency class:
Other
Source:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05524090
