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.
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
- Conditions the study is for
- Locally Advanced Pancreatic Cancer, Borderline Resectable Pancreatic Cancer, Pancreatectomy
- What is being tested?
- Chemotherapy, Radiology and Pancreatectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 400 participants
- Where
- 5 sitesNorway
- Study dates
- 3 Dec 2024to 31 Dec 2028
- 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: 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.
5 sites in 1 country
Norway5 sites, 5 recruiting
- Not yet recruiting
Haukeland University Hospital
Bergen, Norway, 5021
Jon-Helge Angelsen, MD PhD, +47 55 97 50 00, jon-helge.angelsen@helse-bergen.no
- 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
- Not yet 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
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%).
- Conditions
- Locally Advanced Pancreatic Cancer, Borderline Resectable Pancreatic Cancer, Pancreatectomy, Chemotherapy Effect
- 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.
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)
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
Mortality after surgical resection
90-day postoperative mortality ≤5%
Measured: From November 2024-December 2027
Morbidity after surgical resection
90-day postoperative major morbidity (Clavien-Dindo ≥ grade3) of ≤40%
Measured: From November 2024-December 2027
Number of patients evaluated at national MDT undergoing resection
Measured: From November 2024-December 2027
Adverse events
Adverse events during primary chemotherapy
Measured: From November 2023-December 2027
R0 resection rate
R0 (microscopic radical resection >1mm) versus R1 (microscopic residual tumor ≤1mm).
Measured: From November 2023-December 2027
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.]
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.
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.
- First posted25 Apr 2025
- Study start3 Dec 2024
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (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 Locally Advanced Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital of North Norway, Haukeland University Hospital, Helse Stavanger HF, St. Olavs Hospital
- Responsible party
- Principal investigator, Knut Jørgen Labori, Oslo University Hospital
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 38684573Springfeld 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 36932224Stoop 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 38036745Farnes 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