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

NCT ID: NCT06944587

Last Updated: 2025-04-25

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-12-03
• Study Completion Date: 2028-12-31

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%).

Conditions

Locally Advanced Pancreatic Cancer; Borderline Resectable Pancreatic Cancer; Pancreatectomy; Chemotherapy Effect

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Chemotherapy

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

Intervention Type: DRUG

Radiology

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.

Intervention Type: DIAGNOSTIC_TEST

Pancreatectomy

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.

Intervention Type: PROCEDURE

Endoscopy

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)).

Intervention Type: PROCEDURE

Other Intervention Names

Fluorine-18-fluorodeoxyglucose positron emission/computed tomography

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital of North Norway

OTHER

Sponsor Role: collaborator

Haukeland University Hospital

OTHER

Sponsor Role: collaborator

Helse Stavanger HF

OTHER_GOV

Sponsor Role: collaborator

St.Olavs Hospital, Trondheim University Hospital, Norway

UNKNOWN

Sponsor Role: collaborator

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Knut Jørgen Labori

Professor of Surgery, Senior consultant surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Haukeland University Hospital

Bergen, Norway, Norway

Site Status: NOT_YET_RECRUITING

Stavanger University Hospital

Stavanger, Norway, Norway

Site Status: NOT_YET_RECRUITING

University Hospital of North Norway

Tromsø, Norway, Norway

Site Status: NOT_YET_RECRUITING

St. Olavs Hospital, Trondheim University Hospital

Trondheim, Norway, Norway

Site Status: NOT_YET_RECRUITING

Oslo University Hospital

Oslo, , Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Knut Jørgen Labori, MD PhD

Role: CONTACT

uxknab@ous-hf.no

+4723070000

Jacob Ghotbi, MD

Role: CONTACT

Jacob.Ghotbi@ous-hf.no

+4723070000

Facility Contacts

Jon-Helge Angelsen, MD PhD

Role: primary

jon-helge.angelsen@helse-bergen.no

+47 55 97 50 00

Kjetil Søreide, MD PhD

Role: primary

kjetil.soreide@uib.no

+47 51 51 80 00

Linn S Nymo, MD PhD

Role: primary

Linn.Save.Nymo@unn.no

+47 77 62 60 00

Erling A Bringeland, MD PhD

Role: primary

Erling.Audun.Bringeland@stolav.no

+47 72 57 30 00

Knut J Labori, MD PhD

Role: primary

uxknab@ous-hf.no

+4723070000

Jacob Ghotbi, MD

Role: backup

Jacob.Ghotbi@ous-hf.no

+4723070000

References

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.

Reference Type: BACKGROUND

PMID: 38684573 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36932224 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 38036745 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 38155512 (View on PubMed)

Other Identifiers

2023010

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

279530-2023

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

REK sør-øst D 733339

Identifier Type: -

Identifier Source: org_study_id