Clinical trial · Observational
PREOPANC-4 Implementation Program for Locally Advanced Pancreatic Cancer
Nationwide Implementation Program for Optimal Multidisciplinary Management and Resection of Locally Advanced Pancreatic Cancer (PREOPANC-4)
NCT05524090CI-TRIAL-00060629PREOPANC-4recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy Effect | — | UNRESOLVED | — |
| Locally Advanced Pancreatic Adenocarcinoma | Pancreatic Adenocarcinoma | CURATED_BROADER | 0.78 |
| Pancreatic Adenocarcinoma Non-resectable | Pancreatic Neoplasm | PROBABILISTIC | 0.70 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Implementation - International best-practice care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Implementation cohort
- description
- 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.
- interventionNames
- Other: Implementation - International best-practice care
Primary outcomes (4)
- measure
- Resection rate
- timeFrame
- Immediately after completing the inclusion period (December 31, 2024).
- description
- Resection rate of the pancreatic tumor
- measure
- Overall survival (OS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (3)
- DERIVEDStoop 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. PMID 42263216
- DERIVEDStoop 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. PMID 39972248
- DERIVEDSeelen 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. PMID 39970867