REDISCOVER guidelines for borderline-resectable and locally advanced pancreatic cancer: management algorithm, unanswered questions, and future perspectives.
Ugo Boggi, Emanuele F Kauffmann, Niccolò Napoli...
https://pubmed.ncbi.nlm.nih.gov/38684573Actively Recruiting
Age: 18Years +
All Genders
ID06944587
A New Clinical Pathway for Personalized Management of Borderline Resectable and Locally Advanced Pancreatic Cancer - Norwegian Pancreatic Cancer Trial-3 (NORPACT 3)
Led by Oslo University Hospital · Updated on 2025-04-25
400
Participants Needed
5
Research Sites
N/A
Total Duration
On this page
Sponsors
O
Oslo University Hospital
Lead Sponsor
U
University Hospital of North Norway
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating resectability rates and survival outcomes in patients with borderline resectable and locally advanced pancreatic cancer who receive primary chemotherapy. This nationwide Norwegian single-arm prospective study follows national guidelines for diagnosis, oncological treatment, surgery, and follow-up. The goal is to achieve a 50% resection rate in borderline resectable pancreatic cancer and 15% in locally advanced cases, aiming for adequate overall survival and controlled morbidity and mortality after surgery. Participants will receive primary chemotherapy according to national guidelines, preferably using mFOLFIRINOX or gemcitabine-nab-paclitaxel regimens. Surgical exploration and resection may follow chemotherapy, with surgery scheduled within four weeks after the last neoadjuvant infusion. Surgical procedures include pancreatoduodenectomy, distal pancreatectomy with splenectomy, or total pancreatectomy with splenectomy, possibly involving venous or arterial resection and reconstruction. Diagnostic procedures include endoscopic ultrasound fine-needle biopsy for diagnosis and molecular pathology and optional PET/CT scans at baseline and after two months of chemotherapy. Participants will be assessed regularly with quality of life questionnaires at baseline, 3, 6, and 12 months from diagnosis, then yearly thereafter. Researchers will monitor resection rates, overall survival, mortality and morbidity after surgery, adverse events, and molecular pathology markers. The study collects data from November 2023 through December 2027, with a focus on surgical outcomes and patient well-being following treatment.
CONDITIONS
Brief Title
A New Clinical Pathway for Personalized Management of Borderline Resectable and Locally Advanced Pancreatic Cancer
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Diagnosed with borderline resectable or locally advanced pancreatic adenocarcinoma
- Cancer stage Nx, M0 according to UICC 8th version
- Confirmed adenocarcinoma by cytology or histology
- Aged over 18 years
- Considered able to receive primary chemotherapy and possible surgery
- Provided written informed consent
You will not qualify if you...
- Health conditions or performance status preventing primary chemotherapy
- Health conditions or performance status preventing pancreatectomy surgery
- Female patients of child-bearing age not using adequate contraception, pregnant, or breastfeeding
- Mental or physical disorders that interfere with treatment or informed consent
- Any other reason the investigator considers unsuitable for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Baseline and after at least 2 months of chemotherapy
Participants undergo diagnostic procedures including endoscopic ultrasound fine-needle biopsy and optional PET/CT scans as part of the diagnostic work up.
2 visits (in-person)
Treatment
Duration - Approximately 2 months or as per chemotherapy regimen
Participants receive chemotherapy according to national guidelines, preferably mFOLFIRINOX or gemcitabine-nab-paclitaxel, as neoadjuvant treatment before surgery.
Multiple chemotherapy infusions (frequency as per treatment plan)
Surgery and Immediate Post-operative Care
Duration - Up to 4 weeks around surgery
Participants undergo pancreatectomy surgery scheduled within 4 weeks after the last chemotherapy infusion, including standard or pylorus-preserving pancreatoduodenectomy, distal pancreatectomy, or total pancreatectomy with or without vascular resection and reconstruction.
1 surgical admission and immediate post-operative care visits
Post-operative Follow-up
Duration - Up to 12 months and yearly follow-up
Participants are monitored after surgery to assess recovery, adverse events, and quality of life at multiple time points up to 12 months and yearly thereafter.
Visits at 3, 6, 12 months and yearly thereafter
Trial Site Locations
Total: 5 locations
1
Haukeland University Hospital
Bergen, Norway, Norway, 5021
Not Yet Recruiting
2
Stavanger University Hospital
Stavanger, Norway, Norway, 4068
Not Yet Recruiting
3
University Hospital of North Norway
Tromsø, Norway, Norway, 9038
Not Yet Recruiting
4
St. Olavs Hospital, Trondheim University Hospital
Trondheim, Norway, Norway, 7006
Not Yet Recruiting
5
Oslo University Hospital
Oslo, Norway, 0424
Actively Recruiting
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Research Team
K
Knut Jørgen Labori, MD PhD
J
Jacob Ghotbi, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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Published Research Related To This Trial
Neoadjuvant therapy for pancreatic cancer.
Christoph Springfeld, Cristina R Ferrone, Matthew H G Katz...
https://pubmed.ncbi.nlm.nih.gov/36932224Preoperative chemotherapy, radiotherapy and surgical decision-making in patients with borderline resectable and locally advanced pancreatic cancer.
Thomas F Stoop, Rutger T Theijse, Leonard W F Seelen...
https://pubmed.ncbi.nlm.nih.gov/38036745Resection 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).
Ingvild Farnes, Dyre Kleive, Caroline S Verbeke...
https://pubmed.ncbi.nlm.nih.gov/38155512