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NCT Number: NCT06944587

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

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%).

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Key information

Conditions

Locally Advanced Pancreatic Cancer Borderline Resectable Pancreatic Cancer Chemotherapy Effect Pancreatectomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Haukeland University Hospital, Bergen, Norway

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chemotherapy

Drug

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

Radiology

Diagnostic Test

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.

Other names: Fluorine-18-fluorodeoxyglucose positron emission/computed tomography

Pancreatectomy

Procedure

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.

endoscopy

Procedure

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)).

Primary outcomes

  1. Resection rate (of the pancreatic tumour)

    Time frame: From November 2024-December 2027

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

Secondary outcomes

  1. Overall survival

    Time frame: From November 2024-December 2027

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

  2. Mortality after surgical resection

    Time frame: From November 2024-December 2027

    90-day postoperative mortality ≤5%

  3. Morbidity after surgical resection

    Time frame: From November 2024-December 2027

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

  4. Number of patients evaluated at national MDT undergoing resection

    Time frame: From November 2024-December 2027

  5. Adverse events

    Time frame: From November 2023-December 2027

    Adverse events during primary chemotherapy

  6. R0 resection rate

    Time frame: From November 2023-December 2027

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

  7. Quality of life EORTC QLQ-C30

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

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

  8. Quality of life EORTC QLQ-PAN26

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

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

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

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

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

Other outcomes

  1. PET CT

    Time frame: From November 2023-December 2027

    • Extrapancreatic disease detected at baseline PET-CT
    • Correlation of PET-CT findings with histopathological tumor regression grading
    • Correlation of PET-CT findings with CA19-9 dynamics
    • Prognostic value of metabolic tumor response in resected patients

  2. Molecular profiling (KRAS mutation status, MSI) at time of diagnosis

    Time frame: From November 2023-December 2027

    • Number of patients with KRAS mutations, KRAS wild type, or MSI tumors
    • Number of patients undergoing additional genetic profiling and/or targeted therapy in accordance with the national guidelines protocols or ongoing trials.

Study contacts

Contact information is provided by the study sponsor or research team.

Jacob Ghotbi, MD

CONTACT

[email protected]

+4723070000

Knut Jørgen Labori, MD PhD

CONTACT

[email protected]

+4723070000

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • Haukeland University Hospital
  • Helse Stavanger HF
  • St. Olavs Hospital
  • University Hospital of North Norway

Registry information

Official study title

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

Acronym: NORPACT-3

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Apr 25, 2025
Registry last updated
Apr 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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