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

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Diagnostic test, Procedure, Drug
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Norway
Haukeland University Hospital
NOT_YET_RECRUITING
Bergen
Oslo University Hospital
RECRUITING
Oslo
Stavanger University Hospital
NOT_YET_RECRUITING
Stavanger
University Hospital of North Norway
NOT_YET_RECRUITING
Tromsø
St. Olavs Hospital, Trondheim University Hospital
NOT_YET_RECRUITING
Trondheim
Contact Information
Primary
Knut Jørgen Labori, MD PhD
uxknab@ous-hf.no
+4723070000
Backup
Jacob Ghotbi, MD
Jacob.Ghotbi@ous-hf.no
+4723070000
Time Frame
Start Date: 2024-12-03
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 400
Sponsors
Collaborators: University Hospital of North Norway, Haukeland University Hospital, Helse Stavanger HF, St.Olavs Hospital, Trondheim University Hospital, Norway
Leads: Oslo University Hospital

This content was sourced from clinicaltrials.gov