Nationwide implementation of the international multidisciplinary best-practice for locally advanced pancreatic cancer (PREOPANC-4): study protocol.
T F Stoop, L W F Seelen, F R van 't Land...
https://pubmed.ncbi.nlm.nih.gov/39972248Actively Recruiting
Age: 18Years +
All Genders
ID05524090
Nationwide Implementation Program for Optimal Multidisciplinary Management and Resection of Locally Advanced Pancreatic Cancer (PREOPANC-4)
Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) ยท Updated on 2022-09-01
223
Participants Needed
1
Research Sites
313 weeks
Total Duration
On this page
Sponsors
A
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead Sponsor
U
UMC Utrecht
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a nationwide program in the Netherlands that aims to improve care for adults with locally advanced pancreatic cancer (LAPC) who have non-metastasized disease and stable condition after chemotherapy. The program implements international standards of excellence for LAPC surgery, supported by training from four leading expert centers. The goal is to increase the rate of surgical removal of tumors while maintaining survival and safety targets compared to past Dutch patient groups. The program involves a multidisciplinary training and implementation of advanced surgical techniques at three high-volume Dutch centers, with collaboration across other centers. Patients who meet criteria after at least four months of induction chemotherapy with modified FOLFIRINOX or gemcitabine-nab-paclitaxel will be reviewed by an expert panel to select appropriate candidates for surgery. Centers can also seek advice for treatment options and patient referrals. Outcomes will be compared with historical patient data. Participants will be monitored through regular assessments of survival, surgery rates, complications, and quality of life. Data on resection rate, overall survival, in-hospital mortality and morbidity will be collected during and after the inclusion period up to 2030. Patient satisfaction and health status will be measured over two years and beyond. This comprehensive approach aims to safely increase surgery rates and improve care for LAPC patients nationwide.
CONDITIONS
Brief Title
PREOPANC-4 Implementation Program for Locally Advanced Pancreatic Cancer
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Pathology-confirmed locally advanced pancreatic cancer (LAPC)
- Stable disease based on CT scans (RECIST criteria) after at least 4 months of systemic chemotherapy with modified FOLFIRINOX or gemcitabine-nab-paclitaxel
You will not qualify if you...
- Metastatic pancreatic cancer before starting induction chemotherapy
- Tumor involvement of more than 90 degrees of certain arteries (superior mesenteric artery, celiac axis, hepatic artery) or more than 270 degrees portovenous involvement or vessel occlusion according to Dutch Pancreatic Cancer Group definitions
AI-Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Participants are evaluated based on pathology confirmation and CT scans after chemotherapy.
Implementation
Duration - Up to 3 years (until December 31, 2024)
Participants undergo care under an international best-practice multidisciplinary management and selection program for locally advanced pancreatic cancer.
Participants may have multiple visits for multidisciplinary discussions, treatment assessments, and surgical evaluations.
Long-term Monitoring
Duration - Up to 6 years (until December 31, 2029)
Participants are followed to assess overall survival, quality of life, healthcare satisfaction, and treatment outcomes.
Visits at 3, 6, 9, 12, 18, and 24 months from diagnosis, followed by yearly visits.
Trial Site Locations
Total: 1 location
1
Amsterdam UMC, locatie AMC
Amsterdam, North Holland, Netherlands, 1105 AZ
Actively Recruiting
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Research Team
T
Thomas F Stoop, MD
M
Marc G Besselink, MD, MSc, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
Quality of Life Among Patients With Locally Advanced Pancreatic Cancer: A Prospective Nationwide Multicenter Study.
Leonard W F Seelen, Simone Augustinus, Thomas F Stoop...
https://pubmed.ncbi.nlm.nih.gov/39970867