NCT05524090

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
223

participants targeted

Target at P75+ for all trials

Timeline
57mo left

Started Jul 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress51%
Jul 2021Dec 2030

Study Start

First participant enrolled

July 1, 2021

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 16, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 1, 2022

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Expected
Last Updated

September 1, 2022

Status Verified

August 1, 2022

Enrollment Period

3.5 years

First QC Date

August 16, 2022

Last Update Submit

August 29, 2022

Conditions

Pancreatic CancerLocally Advanced Pancreatic AdenocarcinomaPancreatic Adenocarcinoma Non-resectableChemotherapy Effect

Keywords

Nationwide implementation International Best-PracticeThe NetherlandsInternational Best-PracticePatient SelectionPatient-centered

Outcome Measures

Primary Outcomes (4)

  • 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

Secondary Outcomes (3)

  • R0 resection rate

    Immediately after completing the inclusion period (December 31, 2024).

  • Quality of life

    Measured at 3, 6, 9, 12, 18, and 24 months from diagnosis, followed by yearly measurements.

  • Shared decision-making: patients' healthcare satisfaction

    Measured at 3, 6, 9, 12, 18, and 24 months from diagnosis, followed by yearly measurements.

Study Arms (1)

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.

Other: Implementation - International best-practice care

Interventions

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.

Implementation cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amsterdam UMC, locatie AMC

Amsterdam, North Holland, 1105 AZ, Netherlands

RECRUITING

Related Publications (1)

  • 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.

    PMID: 39972248DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Marc G Besselink, MD, MSc, PhD

    Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas F Stoop, MD

CONTACT

+316 547 555 11t.f.stoop@amsterdamUMC.nl

Marc G Besselink, MD, MSc, PhD

CONTACT

+316 16 15 83 45m.g.besselink@amsterdamUMC.nl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
60 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prof. dr. M.G. Besselink

Study Record Dates

First Submitted

August 16, 2022

First Posted

September 1, 2022

Study Start

July 1, 2021

Primary Completion

December 31, 2024

Study Completion (Estimated)

December 31, 2030

Last Updated

September 1, 2022

Record last verified: 2022-08

Locations

NL(1)