NCT06944587 A New Clinical Pathway for Personalized Management of Borderline Resectable and Locally Advanced Pancreatic Cancer
| NCT ID | NCT06944587 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Oslo University Hospital |
| Condition | Locally Advanced Pancreatic Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 400 participants |
| Start Date | 2024-12-03 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 400 participants in total. It began in 2024-12-03 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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%).
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06944587 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Locally Advanced Pancreatic Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06944587 currently recruiting?
Yes, NCT06944587 is actively recruiting participants. Contact the research team at uxknab@ous-hf.no for enrollment information.
Where is the NCT06944587 trial being conducted?
This trial is being conducted at Bergen, Norway, Stavanger, Norway, Tromsø, Norway, Trondheim, Norway and 1 additional location.
Who is sponsoring the NCT06944587 clinical trial?
NCT06944587 is sponsored by Oslo University Hospital. The trial plans to enroll 400 participants.
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