Pancreatic CancerPREOPANC-4NCT05524090
PREOPANC-4 Implementation Program for Locally Advanced Pancreatic Cancer
An observational study of Pancreatic Cancer and Locally Advanced Pancreatic Adenocarcinoma, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Locally Advanced Pancreatic Adenocarcinoma, Pancreatic Adenocarcinoma Non-resectable
- What is being tested?
- Implementation - International best-practice care
- How many people
- 223 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jul 2021to 31 Dec 2030
- How long will I take part?
- 60 Months
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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).
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam UMC, locatie AMC
Amsterdam, North Holland, 1105 AZ
Marc G Besselink, MD, MSc, PhD, m.g.besselink@amsterdamUMC.nl
Thomas F Stoop, MD, +316 547 555 11, t.f.stoop@amsterdamUMC.nl
About this study
Official title: Nationwide Implementation Program for Optimal Multidisciplinary Management and Resection of Locally Advanced Pancreatic Cancer (PREOPANC-4)
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.
Read the 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:
- 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;
- 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:
- 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;
- 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;
- Non-inferior patients' healthcare satisfaction, compared to the Dutch historical cohort of pancreatic cancer patients.
- Conditions
- Pancreatic Cancer, Locally Advanced Pancreatic Adenocarcinoma, Pancreatic Adenocarcinoma Non-resectable, Chemotherapy Effect
- Being tested
- Implementation - International best-practice care
- Keywords
- Nationwide implementation International Best-Practice, The Netherlands, International Best-Practice, Patient Selection, Patient-centered
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation - International best-practice careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Implementation - International best-practice care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resection rate
Resection rate of the pancreatic tumor
Measured: Immediately after completing the inclusion period (December 31, 2024).
Overall survival (OS)
OS from time of resection (mOS, 1-year OS \& 5-year OS)
Measured: After completing the follow-up period (December 31, 2029)
In-hospital mortality
Mortality after resection (during primary hospitalization)
Measured: Yearly assessment throughout the inclusion period
In-hospital major morbidity
Clavien-Dindo grade IIIa or higher major morbidity after resection (during primary hospitalization)
Measured: Yearly assessment throughout the inclusion period
Secondary outcomes (3)
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.
Measured: Immediately after completing the inclusion period (December 31, 2024).
Quality of life
EORTC QLQ-C30: global health status
Outcome measures will be calculated, according to the validated questionnaire manuals.
Measured: 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: Measured at 3, 6, 9, 12, 18, and 24 months from diagnosis, followed by yearly measurements.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2022
- Study start1 Jul 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 223 participants (estimated)
- Target duration
- 60 Months
Sponsor and investigators
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Sponsor type
- University, hospital or other
- Collaborators
- UMC Utrecht, Erasmus Medical Center, Leiden University Medical Center, University Medical Center Groningen, Radboud University Medical Center, Maastricht University Medical Center, Medisch Spectrum Twente, Isala, Frisius Medisch Centrum, Onze Lieve Vrouwe Gasthuis, Amphia ziekenhuis, Jeroen Bosch Ziekenhuis, Catharina Ziekenhuis Eindhoven, University of Colorado, Denver, Heidelberg University, M.D. Anderson Cancer Center, NYU Langone Health, Dutch Cancer Society, Maag Lever Darm Stichting, Deltaplan Alvleesklierkanker
- Responsible party
- Principal investigator, M.G. Besselink, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Marc G Besselink, MD, MSc, PhD, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05524090
- Sponsor's protocol ID
- W21_487 # 21.541
- Acronym
- PREOPANC-4
- Status last verified
- Aug 2022
- First submitted
- 16 Aug 2022
- Last updated
- 1 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Stoop TF, Seelen LWF, van 't Land FR, Scheepens JCM, Ali M, van der Hout AC, van der Kolk BM, Bonsing BA, Lips DJ, Manusama ER, Willemsen FEJA, Daams F, Kazemier G, Patijn GA, de Hingh IH, Wijsman JH, Schreinemakers J, Erdmann JI, Mieog JSD, Klaase JM, Rietjens JAC, Bosscha K, Beuk LPM, Nijkamp MW, den Dulk M, Kop MPM, Liem MSL, Luyer M, Stommel MWJ, Busch OR, Festen S, Bouwense S, Karsten TM, van Ravens TW, Neumann UP, de Meijer VE, Nieuwenhuijs VB, Draaisma WA, Derksen W, Bollen TL, Groot Koerkamp B, van Eijck CHJ, Molenaar IQ, Wolfgang CL, Del Chiaro M, Katz MHG, Hackert T, Wilmink JW, van Santvoort HC, de Wilde RF, Besselink MG; Dutch Pancreatic Cancer Group. Surgical outcomes from nationwide implementation of the international best practice for locally advanced pancreatic cancer (PREOPANC-4) study. Br J Surg. 2026 Aug 27;113(9):znag075. doi: 10.1093/bjs/znag075.
PubMed 42329186Stoop TF, Croce C, Ishida H, Ali M, Javed AA, Halimi A, Oba A, Groot Koerkamp B, Leonhardt CS, Thiels CA, Rangelova E, Sparrelid E, Sotirova I, Leiting JL, Tauchi J, Kobayashi K, Klos M, Beuk LPM, Genova L, Mastronardi M, Kendrick ML, Mughal NA, Busch OR, Franklin O, Larsson P, Klaiber U, Schulick RD, Theijse RT, Strobel O, Ghorbani P, de Wilde RF, Rodriguez Franco S, Sugawara T, Wilmink JW, Messersmith W, Besselink MG, Wolfgang CL, Inoue Y, Truty MJ, Del Chiaro M; International Collaboration on Advanced Pancreatic Cancer. Neurogenic diarrhoea after superior mesenteric artery divestment or resection for pancreatic adenocarcinoma following preoperative chemotherapy: international multicentre retrospective study. BJS Open. 2026 May 12;10(3):zrag057. doi: 10.1093/bjsopen/zrag057.
PubMed 42263216Stoop 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.
PubMed 39972248Seelen 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.
PubMed 39970867