Brief Summary

NORPACT-3 is a nationwide, Norwegian single arm prospective study that evaluates the resectability rates and survival in patients with borderline resectable and locally advanced pancreatic cancer who received primary chemotherapy. Eligible patients are treated with primary chemotherapy possibly followed by surgical exploration and resection. All Norwegian centres performing pancreatic surgery have agreed to collaborate in this trial. The assignment of the medical intervention is not at the discretion of the investigator, but follow the national Norwegian guidelines regarding diagnostic work up, oncological and surgical treatment and follow up. The primary aim is a national resection rate of 50% in BRPC and 15% in LAPC in patients initiating primary chemotherapy, with adequate overall survival and morbidity/mortality (after resection median overall survival of 24 months, 1 year survival 80%, and 5 year survival \>20% + 90 day postoperative mortality ≤5%, 90-day postoperative major morbidity (Clavien Dindo grade 3) ≤40%).

Trial Health

On Track

Trial Health Score

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

Enrollment

400

participants targeted

Target at P75+ for all trials

Timeline

33mo left

Started Dec 2024

Longer than P75 for all trials

Geographic Reach

1 country

5 active sites

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

4.1 years study duration

Study Progress35%

Dec 2024Dec 2028

Study Start

First participant enrolled

December 3, 2024

Completed

2 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2025

Completed

3 months until next milestone

First Posted

Study publicly available on registry

April 25, 2025

Completed

3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

April 25, 2025

Status Verified

April 1, 2025

Enrollment Period

4.1 years

First QC Date

January 17, 2025

Last Update Submit

April 17, 2025

Conditions

Locally Advanced Pancreatic Cancer Borderline Resectable Pancreatic Cancer Pancreatectomy Chemotherapy Effect

Keywords

Primary chemotherapyResection rateBorderline Resectable Pancreatic CancerLocally Advanced Pancreatic CancerPancreatectomyChemotherapy EffectFDG PET-CTctDNA

Outcome Measures

Primary Outcomes (1)

Resection rate (of the pancreatic tumour)
Resection rate: National target of 50% in BRPC and 15% in LAPC in patients initiating primary chemotherapy.
From November 2024-December 2027

Secondary Outcomes (9)

Overall survival
From November 2024-December 2027
Mortality after surgical resection
From November 2024-December 2027
Morbidity after surgical resection
From November 2024-December 2027
Number of patients evaluated at national MDT undergoing resection
From November 2024-December 2027
Adverse events
From November 2023-December 2027
+4 more secondary outcomes

Other Outcomes (2)

PET CT
From November 2023-December 2027
Molecular profiling (KRAS mutation status, MSI) at time of diagnosis
From November 2023-December 2027

Interventions

ChemotherapyDRUG

The choice of chemotherapy regimen follows national guidelines, preferably mFOLFIRINOX or gemcitabine-nab-paclitaxel.

RadiologyDIAGNOSTIC_TEST

PET/CT is optional. PET/CT will be offered as a part of the diagnostic work up at baseline and one additional scan after a minimum of two months of chemotherapy.

Also known as: Fluorine-18-fluorodeoxyglucose positron emission/computed tomography

PancreatectomyPROCEDURE

Surgery is scheduled within 4 weeks after the last neoadjuvant infusion. Resection will be performed as a standard or pylorus-preserving pancreatoduodenectomy (PD), distal pancreatectomy (DP) with splenectomy, or total pancreatectomy (TP) with splenectomy, and with or without venous or arterial resection and reconstruction.

EndoscopyPROCEDURE

Endoscopic ultrasound fine-needle biopsy to establish the diagnosis with histopathology and to obtain an adequate sample for molecular pathology (KRAS status (mutation or wild type), microsatellite instability (MSI)).

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Nationwide, population based cohort from a universal health care system

You may qualify if:

Borderline resectable or locally advanced adenocarcinoma of the pancreas (NCCN, version 2, 2021) (Appendix 3)
Nx, M0 (UICC 8th version, 2016)
Cytological or histological confirmation of adenocarcinoma
Age \>18 year
Considered able to receive primary chemotherapy and possible surgery
Written informed consent

You may not qualify if:

Co-morbidity or performance status precluding primary chemotherapy
Co-morbidity or performance status precluding pancreatectomy
Female patients in child-bearing age not using adequate contraception, pregnant or lactating women
Mental or physical disorders that could interfere with treatment of with the provision of informed consent
Any reason why, in the opinion of the investigator, the patient should not participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Oslo University Hospitallead
University Hospital of North Norwaycollaborator
Haukeland University Hospitalcollaborator
Helse Stavanger HFcollaborator
St.Olavs Hospital, Trondheim University Hospital, Norwaycollaborator

Study Sites (5)

Haukeland University Hospital

Bergen, Norway, 5021, Norway

NOT YET RECRUITING

Stavanger University Hospital

Stavanger, Norway, 4068, Norway

NOT YET RECRUITING

University Hospital of North Norway

Tromsø, Norway, 9038, Norway

NOT YET RECRUITING

St. Olavs Hospital, Trondheim University Hospital

Trondheim, Norway, 7006, Norway

NOT YET RECRUITING

Oslo University Hospital

Oslo, 0424, Norway

RECRUITING

Related Publications (4)

Boggi U, Kauffmann EF, Napoli N, Barreto SG, Besselink MG, Fusai GK, Hackert T, Hilal MA, Marchegiani G, Salvia R, Shrikhande SV, Truty M, Werner J, Wolfgang C, Bannone E, Capretti G, Cattelani A, Coppola A, Cucchetti A, De Sio D, Di Dato A, Di Meo G, Fiorillo C, Gianfaldoni C, Ginesini M, Hidalgo Salinas C, Lai Q, Miccoli M, Montorsi R, Pagnanelli M, Poli A, Ricci C, Sucameli F, Tamburrino D, Viti V, Cameron J, Clavien PA, Asbun HJ; REDISCOVER guidelines group. REDISCOVER guidelines for borderline-resectable and locally advanced pancreatic cancer: management algorithm, unanswered questions, and future perspectives. Updates Surg. 2024 Sep;76(5):1573-1591. doi: 10.1007/s13304-024-01860-0. Epub 2024 Apr 29.
PMID: 38684573BACKGROUND
Springfeld C, Ferrone CR, Katz MHG, Philip PA, Hong TS, Hackert T, Buchler MW, Neoptolemos J. Neoadjuvant therapy for pancreatic cancer. Nat Rev Clin Oncol. 2023 May;20(5):318-337. doi: 10.1038/s41571-023-00746-1. Epub 2023 Mar 17.
PMID: 36932224BACKGROUND
Stoop TF, Theijse RT, Seelen LWF, Groot Koerkamp B, van Eijck CHJ, Wolfgang CL, van Tienhoven G, van Santvoort HC, Molenaar IQ, Wilmink JW, Del Chiaro M, Katz MHG, Hackert T, Besselink MG; International Collaborative Group on Locally Advanced Pancreatic Cancer. Preoperative chemotherapy, radiotherapy and surgical decision-making in patients with borderline resectable and locally advanced pancreatic cancer. Nat Rev Gastroenterol Hepatol. 2024 Feb;21(2):101-124. doi: 10.1038/s41575-023-00856-2. Epub 2023 Nov 30.
PMID: 38036745BACKGROUND
Farnes I, Kleive D, Verbeke CS, Aabakken L, Issa-Epe A, Smastuen MC, Fosby BV, Dueland S, Line PD, Labori KJ. Resection rates and intention-to-treat outcomes in borderline and locally advanced pancreatic cancer: real-world data from a population-based, prospective cohort study (NORPACT-2). BJS Open. 2023 Nov 1;7(6):zrad137. doi: 10.1093/bjsopen/zrad137.
PMID: 38155512BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples for circulating tumor DNA analysis

MeSH Terms

Interventions

Drug TherapyDiagnostic ImagingTomography, X-Ray ComputedPancreatectomyEndoscopy

Intervention Hierarchy (Ancestors)

TherapeuticsDiagnostic Techniques and ProceduresDiagnosisImage Interpretation, Computer-AssistedRadiographic Image EnhancementImage EnhancementPhotographyRadiographyTomography, X-RayTomographyDigestive System Surgical ProceduresSurgical Procedures, OperativeDiagnostic Techniques, SurgicalMinimally Invasive Surgical Procedures

Central Study Contacts

Knut Jørgen Labori, MD PhD

CONTACT

+4723070000 uxknab@ous-hf.no

Jacob Ghotbi, MD

CONTACT

+4723070000 Jacob.Ghotbi@ous-hf.no

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Professor of Surgery, Senior consultant surgeon

Study Record Dates

First Submitted

January 17, 2025

First Posted

April 25, 2025

Study Start

December 3, 2024

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

April 25, 2025

Record last verified: 2025-04

Locations

NO(5)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (9)

Other Outcomes (2)

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (5)

Related Publications (4)

Biospecimen

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

Locations