NCT06944587Recruiting
A New Clinical Pathway for Personalized Management of Borderline Resectable and Locally Advanced Pancreatic Cancer
A New Clinical Pathway for Personalized Management of Borderline Resectable and Locally Advanced Pancreatic Cancer - Norwegian Pancreatic Cancer Trial-3 (NORPACT 3)
Source: ClinicalTrials.gov · Last updated 25 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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%).
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 400 (estimated)
- First submitted
- 17 Jan 2025
- Start date
- 3 Dec 2024
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Oslo University Hospital
- Diseases
- Pancreatic cancer
- NCT number
- NCT06944587
What you commit to
- Study type: Observational
- Planned participants: 400
- From 3 Dec 2024 to the primary completion date, 31 Dec 2028
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Co-morbidity or performance status precluding primary chemotherapy
Other illness
- Mental or physical disorders that could interfere with treatment of with the provision of informed consent
Age
- Female patients in child-bearing age not using adequate contraception, pregnant or lactating women
Other
- Co-morbidity or performance status precluding pancreatectomy
- Any reason why, in the opinion of the investigator, the patient should not participate
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Haukeland University Hospital Coordinator of this site? Confirm its status | Bergen | Norway | Not yet recruiting |
| Oslo University Hospital Coordinator of this site? Confirm its status | Oslo | Norway | Recruiting |
| Stavanger University Hospital Coordinator of this site? Confirm its status | Stavanger | Norway | Not yet recruiting |
| University Hospital of North Norway Coordinator of this site? Confirm its status | Tromsø | Norway | Not yet recruiting |
| St. Olavs Hospital, Trondheim University Hospital Coordinator of this site? Confirm its status | Trondheim | Norway | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.