PREOPANC-4 Implementation Program for Locally Advanced Pancreatic Cancer
NCT ID: NCT05524090
Last Updated: 2022-09-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
223 participants
OBSERVATIONAL
2021-07-01
2030-12-31
Brief Summary
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The PREOPANC-4 project aims a safe and patient-centered implementation of the international standards of excellence for LAPC (surgery) in the Netherlands.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Implementation cohort
Inclusion criteria:
1. Age ≥18 years;
2. Pathology confirmed LAPC\*;
3. CT-based non-progressive disease in accordance with the RECIST criteria after at least 4 months of systemic chemotherapy (\[m\]FOLFIRINOX or gemcitabine-nab-paclitaxel).
Exclusion criteria:
(1) 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.
Implementation - International best-practice care
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.
Interventions
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Implementation - International best-practice care
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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UMC Utrecht
OTHER
Erasmus Medical Center
OTHER
Leiden University Medical Center
OTHER
University Medical Center Groningen
OTHER
Radboud University Medical Center
OTHER
Maastricht University Medical Center
OTHER
Medisch Spectrum Twente
OTHER
Isala
OTHER
Frisius Medisch Centrum
OTHER
Onze Lieve Vrouwe Gasthuis
OTHER
Amphia ziekenhuis
UNKNOWN
Jeroen Bosch Ziekenhuis
OTHER
Catharina Ziekenhuis Eindhoven
OTHER
University of Colorado, Denver
OTHER
Heidelberg University
OTHER
M.D. Anderson Cancer Center
OTHER
NYU Langone Health
OTHER
Dutch Cancer Society
OTHER
Maag Lever Darm Stichting
OTHER
Deltaplan Alvleesklierkanker
UNKNOWN
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER
Responsible Party
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M.G. Besselink
prof. dr. M.G. Besselink
Principal Investigators
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Marc G Besselink, MD, MSc, PhD
Role: PRINCIPAL_INVESTIGATOR
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Locations
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Amsterdam UMC, locatie AMC
Amsterdam, North Holland, Netherlands
Countries
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Central Contacts
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Facility Contacts
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References
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Stoop TF, Seelen LWF, van 't Land FR, van der Hout AC, Scheepens JCM, Ali M, Stiggelbout AM, van der Kolk BM, Bonsing BA, Lips DJ, de Groot DJA, van Veldhuisen E, Kerver ED, Manusama ER, Daams F, Kazemier G, Cirkel GA, van Tienhoven G, Patijn GA, Lelieveld-Rier HN, de Hingh IH, van Hellemond IEG, Wijsman JH, Erdmann JI, Mieog JSD, de Vos-Geelen J, de Groot JWB, Lutchman KRD, Mekenkamp LJ, Kranenburg LW, Beuk LPM, Nijkamp MW, den Dulk M, Polee MB, Homs MYV, Wumkes ML, Stommel MWJ, Busch OR, de Wilde RF, Theijse RT, Luelmo SAC, Festen S, Bollen TL, Neumann UP, de Meijer VE, Draaisma WA, Groot Koerkamp B, Molenaar IQ, Wolfgang CL, Del Chiaro M, Katz MGH, Hackert T, Rietjens JAC, Wilmink JW, van Santvoort HC, van Eijck CHJ, Besselink MG; Dutch Pancreatic Cancer Group. Nationwide implementation of the international multidisciplinary best-practice for locally advanced pancreatic cancer (PREOPANC-4): study protocol. BMC Cancer. 2025 Feb 19;25(1):299. doi: 10.1186/s12885-025-13554-w.
Other Identifiers
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W21_487 # 21.541
Identifier Type: -
Identifier Source: org_study_id
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