Clinical trial NCT06944587: A New Clinical Pathway for Personalized Management of Borderline Resectable and Locally Advanced Pancreatic Cancer
Official title: A New Clinical Pathway for Personalized Management of Borderline Resectable and Locally Advanced Pancreatic Cancer - Norwegian Pancreatic Cancer Trial-3 (NORPACT 3)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Locally Advanced Pancreatic Cancer
Borderline Resectable Pancreatic Cancer
Pancreatectomy
Chemotherapy Effect
Keywords: Primary chemotherapy
Resection rate
Borderline Resectable Pancreatic Cancer
Locally Advanced Pancreatic Cancer
Pancreatectomy
Chemotherapy Effect
FDG PET-CT
ctDNA
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: University Hospital of North Norway
name: Haukeland University Hospital
name: Helse Stavanger HF
name: St.Olavs Hospital, Trondheim University Hospital, Norway
First posted: 2025-04-25
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Nationwide, population based cohort from a universal health care system

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

Primary outcomes:
measure: Resection rate (of the pancreatic tumour)
timeFrame: From November 2024-December 2027
Secondary outcomes:
measure: Overall survival
timeFrame: From November 2024-December 2027
measure: Mortality after surgical resection
timeFrame: From November 2024-December 2027
measure: Morbidity after surgical resection
timeFrame: From November 2024-December 2027
measure: Number of patients evaluated at national MDT undergoing resection
timeFrame: From November 2024-December 2027
measure: Adverse events
timeFrame: From November 2023-December 2027
measure: R0 resection rate
timeFrame: From November 2023-December 2027
measure: Quality of life EORTC QLQ-C30
timeFrame: Measured at baseline, 3, 6, and 12 months from diagnosis, followed by yearly measurements.]
measure: Quality of life EORTC QLQ-PAN26
timeFrame: Measured at baseline, 3, 6, and 12 months from diagnosis, followed by yearly measurements.
measure: Quality of life EQ-5D-5L
timeFrame: Measured at baseline, 3, 6, and 12 months from diagnosis, followed by yearly measurements.
Other outcomes:
measure: PET CT
timeFrame: From November 2023-December 2027
measure: Molecular profiling (KRAS mutation status, MSI) at time of diagnosis
timeFrame: From November 2023-December 2027
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
city: Oslo
country: Norway
facility: Oslo University Hospital
city: Stavanger
country: Norway
facility: Stavanger University Hospital
city: Tromsø
country: Norway
facility: University Hospital of North Norway
city: Trondheim
country: Norway
facility: St. Olavs Hospital, Trondheim University Hospital
Study officials:
References:
citation: Boggi U, Kauffmann EF, Napoli N, Barreto SG, Besselink MG, Fusai GK, Hackert T, Hilal MA, Marchegiani G, Salvia R, Shrikhande SV, Truty M, Werner J, Wolfgang C, Bannone E, Capretti G, Cattelani A, Coppola A, Cucchetti A, De Sio D, Di Dato A, Di Meo G, Fiorillo C, Gianfaldoni C, Ginesini M, Hidalgo Salinas C, Lai Q, Miccoli M, Montorsi R, Pagnanelli M, Poli A, Ricci C, Sucameli F, Tamburrino D, Viti V, Cameron J, Clavien PA, Asbun HJ; REDISCOVER guidelines group. REDISCOVER guidelines for borderline-resectable and locally advanced pancreatic cancer: management algorithm, unanswered questions, and future perspectives. Updates Surg. 2024 Sep;76(5):1573-1591. doi: 10.1007/s13304-024-01860-0. Epub 2024 Apr 29.
citation: Springfeld C, Ferrone CR, Katz MHG, Philip PA, Hong TS, Hackert T, Buchler MW, Neoptolemos J. Neoadjuvant therapy for pancreatic cancer. Nat Rev Clin Oncol. 2023 May;20(5):318-337. doi: 10.1038/s41571-023-00746-1. Epub 2023 Mar 17.
citation: Stoop TF, Theijse RT, Seelen LWF, Groot Koerkamp B, van Eijck CHJ, Wolfgang CL, van Tienhoven G, van Santvoort HC, Molenaar IQ, Wilmink JW, Del Chiaro M, Katz MHG, Hackert T, Besselink MG; International Collaborative Group on Locally Advanced Pancreatic Cancer. Preoperative chemotherapy, radiotherapy and surgical decision-making in patients with borderline resectable and locally advanced pancreatic cancer. Nat Rev Gastroenterol Hepatol. 2024 Feb;21(2):101-124. doi: 10.1038/s41575-023-00856-2. Epub 2023 Nov 30.
citation: Farnes I, Kleive D, Verbeke CS, Aabakken L, Issa-Epe A, Smastuen MC, Fosby BV, Dueland S, Line PD, Labori KJ. Resection rates and intention-to-treat outcomes in borderline and locally advanced pancreatic cancer: real-world data from a population-based, prospective cohort study (NORPACT-2). BJS Open. 2023 Nov 1;7(6):zrad137. doi: 10.1093/bjsopen/zrad137.