Personalized management for 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)
This study is testing if giving chemotherapy first can help people with borderline resectable and locally advanced pancreatic cancer have surgery and improve their chances of survival.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Oslo University Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 5 sites (Bergen, Norway and 4 other locations) |
| Trial ID | NCT06944587 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of primary chemotherapy in patients with borderline resectable and locally advanced pancreatic cancer across Norway. Patients receive chemotherapy followed by potential surgical exploration and resection, adhering to national guidelines for treatment. The primary goal is to achieve a resection rate of 50% for borderline resectable cases and 15% for locally advanced cases, while also monitoring overall survival and postoperative outcomes. The study involves collaboration among all Norwegian centers that perform pancreatic surgery.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with borderline resectable or locally advanced pancreatic adenocarcinoma who can tolerate chemotherapy and possible surgery.
Not a fit: Patients with severe co-morbidities or performance status that prevents them from undergoing chemotherapy or surgery will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve surgical outcomes and survival rates for patients with challenging pancreatic cancer cases.
How similar studies have performed: Previous studies have shown promising results with similar approaches in managing pancreatic cancer, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bergen, Norway and 4 other locations
- Haukeland University Hospital — Bergen, Norway, Norway (Not_yet_recruiting)
- Stavanger University Hospital — Stavanger, Norway, Norway (Not_yet_recruiting)
- University Hospital of North Norway — Tromsø, Norway, Norway (Not_yet_recruiting)
- St. Olavs Hospital, Trondheim University Hospital — Trondheim, Norway, Norway (Not_yet_recruiting)
- Oslo University Hospital — Oslo, Norway (Recruiting)
Study contacts
- Study coordinator: Knut Jørgen Labori, MD PhD
- Email: uxknab@ous-hf.no
- Phone: +4723070000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.