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

NCT06944587 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2025-04-25

No results posted yet for this 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%).

Conditions

Interventions

DRUG

Chemotherapy

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

DIAGNOSTIC_TEST

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.

PROCEDURE

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.

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)).

Sponsors & Collaborators

  • University Hospital of North Norway

    collaborator OTHER

  • Haukeland University Hospital

    collaborator OTHER

  • Helse Stavanger HF

    collaborator OTHER_GOV

  • St.Olavs Hospital, Trondheim University Hospital, Norway

    collaborator UNKNOWN

  • Oslo University Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-03
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • Norway

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06944587 on ClinicalTrials.gov