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Locally Advanced Pancreatic CancerNORPACT-3NCT06944587

A New Clinical Pathway for Personalized Management of Borderline Resectable and Locally Advanced Pancreatic Cancer

An observational study of Locally Advanced Pancreatic Cancer and Borderline Resectable Pancreatic Cancer, run by Oslo University Hospital at 5 sites in Norway.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Chemotherapy, Radiology and Pancreatectomy
How many people
400 participants
Where
5 sitesNorway
Study dates
3 Dec 2024to 31 Dec 2028
Phase
Observational
Are there results?
Not yet: the study is under way

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: Nationwide, population based cohort from a universal health care system

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Knut Jørgen Labori, MD PhD contact

+4723070000

uxknab@ous-hf.no

Jacob Ghotbi, MD contact

+4723070000

Jacob.Ghotbi@ous-hf.no

5 sites in 1 country

Norway5 sites, 5 recruiting

  • Haukeland University Hospital

    Bergen, Norway, 5021

    Jon-Helge Angelsen, MD PhD, +47 55 97 50 00, jon-helge.angelsen@helse-bergen.no

    Not yet recruiting

  • Oslo University Hospital

    Oslo, 0424

    Knut J Labori, MD PhD, +4723070000, uxknab@ous-hf.no

    Jacob Ghotbi, MD, +4723070000, Jacob.Ghotbi@ous-hf.no

    Recruiting

  • Stavanger University Hospital

    Stavanger, Norway, 4068

    Kjetil Søreide, MD PhD, +47 51 51 80 00, kjetil.soreide@uib.no

    Not yet recruiting

  • University Hospital of North Norway

    Tromsø, Norway, 9038

    Linn S Nymo, MD PhD, +47 77 62 60 00, Linn.Save.Nymo@unn.no

    Not yet recruiting

  • St. Olavs Hospital, Trondheim University Hospital

    Trondheim, Norway, 7006

    Erling A Bringeland, MD PhD, +47 72 57 30 00, Erling.Audun.Bringeland@stolav.no

    Not yet recruiting

Other trials in Norway

About this study

Official title: A New Clinical Pathway for Personalized Management of Borderline Resectable and Locally Advanced Pancreatic Cancer - Norwegian Pancreatic Cancer Trial-3 (NORPACT 3)

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%).

Being tested
Chemotherapy, Radiology, Pancreatectomy, Endoscopy
Keywords
Primary chemotherapy, Resection rate, Borderline Resectable Pancreatic Cancer, Locally Advanced Pancreatic Cancer, Pancreatectomy, Chemotherapy Effect, FDG PET-CT, ctDNA

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ChemotherapyDrug

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

  • RadiologyDiagnostic test

    Also called Fluorine-18-fluorodeoxyglucose positron emission/computed tomography

    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.

  • PancreatectomyProcedure or surgery

    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 or surgery

    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)).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Resection rate (of the pancreatic tumour)

    Resection rate: National target of 50% in BRPC and 15% in LAPC in patients initiating primary chemotherapy.

    Measured: From November 2024-December 2027

Secondary outcomes (9)

  1. Overall survival

    After resection, median overall survival of 24 months, 1 year survival 80%, and 5 year survival >20%.

    Measured: From November 2024-December 2027

  2. Mortality after surgical resection

    90-day postoperative mortality ≤5%

    Measured: From November 2024-December 2027

  3. Morbidity after surgical resection

    90-day postoperative major morbidity (Clavien-Dindo ≥ grade3) of ≤40%

    Measured: From November 2024-December 2027

  4. Number of patients evaluated at national MDT undergoing resection

    Measured: From November 2024-December 2027

  5. Adverse events

    Adverse events during primary chemotherapy

    Measured: From November 2023-December 2027

  6. R0 resection rate

    R0 (microscopic radical resection >1mm) versus R1 (microscopic residual tumor ≤1mm).

    Measured: From November 2023-December 2027

  7. Quality of life EORTC QLQ-C30

    Outcome measures will be calculated, according to the validated questionnaire manuals.

    Measured: Measured at baseline, 3, 6, and 12 months from diagnosis, followed by yearly measurements.]

  8. Quality of life EORTC QLQ-PAN26

    Outcome measures will be calculated, according to the validated questionnaire manuals.

    Measured: Measured at baseline, 3, 6, and 12 months from diagnosis, followed by yearly measurements.

  9. Quality of life EQ-5D-5L

    Outcome measures will be calculated, according to the validated questionnaire manuals.

    Measured: Measured at baseline, 3, 6, and 12 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.

  1. First posted25 Apr 2025
  2. Study start3 Dec 2024
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

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
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06944587
Sponsor's protocol ID
REK sør-øst D 733339
Other IDs
2023010, 279530-2023
Acronym
NORPACT-3
Status last verified
Apr 2025
First submitted
17 Jan 2025
Last updated
25 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 38684573

  • 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.

    PubMed 36932224

  • 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.

    PubMed 38036745

  • 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.

    PubMed 38155512

Questions about this trial

What is this clinical trial studying?

An observational study of Locally Advanced Pancreatic Cancer and Borderline Resectable Pancreatic Cancer, run by Oslo University Hospital at 5 sites in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Knut Jørgen Labori, MD PhD (+4723070000, uxknab@ous-hf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Resection rate (of the pancreatic tumour) (time frame: From November 2024-December 2027). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06944587, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2025.

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