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

Last updated: April 17, 2025
Sponsor: Oslo University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Digestive System Neoplasms

Treatment

Endoscopy

Radiology

Chemotherapy

Clinical Study ID

NCT06944587
REK sør-øst D 733339
2023010
279530-2023
  • Ages > 18
  • All Genders

Study 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%).

Eligibility Criteria

Inclusion

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

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 orlactating women

  • Mental or physical disorders that could interfere with treatment of with theprovision of informed consent

  • Any reason why, in the opinion of the investigator, the patient should notparticipate

Study Design

Total Participants: 400
Treatment Group(s): 4
Primary Treatment: Endoscopy
Phase:
Study Start date:
December 03, 2024
Estimated Completion Date:
December 31, 2028

Connect with a study center

  • Haukeland University Hospital

    Bergen, 5021
    Norway

    Site Not Available

  • Oslo University Hospital

    Oslo, 0424
    Norway

    Active - Recruiting

  • Stavanger University Hospital

    Stavanger, 4068
    Norway

    Site Not Available

  • University Hospital of North Norway

    Tromsø, 9038
    Norway

    Site Not Available

  • St. Olavs Hospital, Trondheim University Hospital

    Trondheim, 7006
    Norway

    Site Not Available

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