Actively Recruiting
A New Clinical Pathway for Personalized Management of Borderline Resectable and Locally Advanced Pancreatic Cancer
Led by Oslo University Hospital · Updated on 2025-04-25
400
Participants Needed
5
Research Sites
212 weeks
Total Duration
On this page
Sponsors
O
Oslo University Hospital
Lead Sponsor
U
University Hospital of North Norway
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
A New Clinical Pathway for Personalized Management of Borderline Resectable and Locally Advanced Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Borderline resectable or locally advanced adenocarcinoma of the pancreas
- No distant metastasis (Nx, M0)
- Cytological or histological confirmation of adenocarcinoma
- Age over 18 years
- Considered able to receive primary chemotherapy and possible surgery
- Provided written informed consent
You will not qualify if you...
- Health problems or poor performance status preventing primary chemotherapy
- Health problems or poor performance status preventing pancreatectomy
- Female patients of child-bearing age not using adequate contraception, pregnant or lactating women
- Mental or physical disorders interfering with treatment or informed consent
- Any other reason the investigator believes the patient should not participate
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Haukeland University Hospital
Bergen, Norway, Norway, 5021
Not Yet Recruiting
2
Stavanger University Hospital
Stavanger, Norway, Norway, 4068
Not Yet Recruiting
3
University Hospital of North Norway
Tromsø, Norway, Norway, 9038
Not Yet Recruiting
4
St. Olavs Hospital, Trondheim University Hospital
Trondheim, Norway, Norway, 7006
Not Yet Recruiting
5
Oslo University Hospital
Oslo, Norway, 0424
Actively Recruiting
Research Team
K
Knut Jørgen Labori, MD PhD
CONTACT
J
Jacob Ghotbi, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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