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| Name | Class |
|---|---|
| UMC Utrecht | OTHER |
| Erasmus Medical Center | OTHER |
| Leiden University Medical Center | OTHER |
| University Medical Center Groningen |
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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.
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:
Secondary targets:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Implementation cohort | Inclusion criteria:
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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implementation - International best-practice care | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Resection rate | Resection rate of the pancreatic tumor | Immediately after completing the inclusion period (December 31, 2024). |
| Overall survival (OS) | OS from time of resection (mOS, 1-year OS & 5-year OS) | After completing the follow-up period (December 31, 2029) |
| In-hospital mortality | Mortality after resection (during primary hospitalization) | Yearly assessment throughout the inclusion period |
| In-hospital major morbidity | Clavien-Dindo grade IIIa or higher major morbidity after resection (during primary hospitalization) | Yearly assessment throughout the inclusion period |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Immediately after completing the inclusion period (December 31, 2024). |
| Quality of life |
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Inclusion Criteria:
Exclusion Criteria:
Metastatic pancreatic cancer prior to induction chemotherapy.
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thomas F Stoop, MD | Contact | +316 547 555 11 | t.f.stoop@amsterdamUMC.nl | |
| Marc G Besselink, MD, MSc, PhD | Contact | +316 16 15 83 45 | m.g.besselink@amsterdamUMC.nl |
| Name | Affiliation | Role |
|---|---|---|
| Marc G Besselink, MD, MSc, PhD | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amsterdam UMC, locatie AMC | Recruiting | Amsterdam | North Holland | 1105 AZ | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39972248 | Derived | 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. | |
| 39970867 |
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| 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 |
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EORTC QLQ-C30: global health status Outcome measures will be calculated, according to the validated questionnaire manuals. |
| Measured at 3, 6, 9, 12, 18, and 24 months from diagnosis, followed by yearly measurements. |
| Shared decision-making: patients' healthcare satisfaction | APECC decision-making self-efficacy scale. Outcome measures will be calculated, according to the validated questionnaire manuals. | Measured at 3, 6, 9, 12, 18, and 24 months from diagnosis, followed by yearly measurements. |
| Derived |
| Seelen LWF, Augustinus S, Stoop TF, Bouwense SAW, Busch OR, Cirkel GA, van Eijck CHJ, de Vos-Geelen J, Groot Koerkamp B, Haj Mohammad N, de Hingh IHJT, van Alphen E, Homs MYV, Liem MSL, Los M, de Meijer VE, Mekenkamp LJM, Sprangers MAG, Stommel MWJ, Wilmink JW, Besselink MG, van Santvoort HC, van Laarhoven HWM, Molenaar IQ; Dutch Pancreatic Cancer Group. Quality of Life Among Patients With Locally Advanced Pancreatic Cancer: A Prospective Nationwide Multicenter Study. J Natl Compr Canc Netw. 2025 Feb 19;23(3):97-104. doi: 10.6004/jnccn.2024.7091. |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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