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| ID | Type | Description | Link |
|---|---|---|---|
| 2023010 | Other Grant/Funding Number | Southern and Eastern Norway Regional Health Authority | |
| 279530-2023 | Other Grant/Funding Number | Norwegian Cancer Society |
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| Name | Class |
|---|---|
| University Hospital of North Norway | OTHER |
| Haukeland University Hospital | OTHER |
| Helse Stavanger HF | OTHER_GOV |
| St. Olavs Hospital |
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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%).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chemotherapy | Drug | The choice of chemotherapy regimen follows national guidelines, preferably mFOLFIRINOX or gemcitabine-nab-paclitaxel. | ||
| Radiology | Diagnostic Test | PET/CT is optional. PET/CT will be offered as a part of the diagnostic work up at baseline and one additional scan after a minimum of two months of chemotherapy. |
| |
| Pancreatectomy | Procedure | Surgery is scheduled within 4 weeks after the last neoadjuvant infusion. Resection will be performed as a standard or pylorus-preserving pancreatoduodenectomy (PD), distal pancreatectomy (DP) with splenectomy, or total pancreatectomy (TP) with splenectomy, and with or without venous or arterial resection and reconstruction. | ||
| Endoscopy | Procedure | Endoscopic ultrasound fine-needle biopsy to establish the diagnosis with histopathology and to obtain an adequate sample for molecular pathology (KRAS status (mutation or wild type), microsatellite instability (MSI)). |
| Measure | Description | Time Frame |
|---|---|---|
| Resection rate (of the pancreatic tumour) | Resection rate: National target of 50% in BRPC and 15% in LAPC in patients initiating primary chemotherapy. | From November 2024-December 2027 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | After resection, median overall survival of 24 months, 1 year survival 80%, and 5 year survival >20%. | From November 2024-December 2027 |
| Mortality after surgical resection | 90-day postoperative mortality ≤5% |
| Measure | Description | Time Frame |
|---|---|---|
| PET CT |
| From November 2023-December 2027 |
| Molecular profiling (KRAS mutation status, MSI) at time of diagnosis |
Inclusion Criteria:
Exclusion Criteria:
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Nationwide, population based cohort from a universal health care system
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Knut Jørgen Labori, MD PhD | Contact | +4723070000 | uxknab@ous-hf.no | |
| Jacob Ghotbi, MD | Contact | +4723070000 | Jacob.Ghotbi@ous-hf.no |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haukeland University Hospital | Not yet recruiting | Bergen | Norway | 5021 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38684573 | Background | 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. | |
| 36932224 |
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| OTHER |
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Blood samples for circulating tumor DNA analysis
| From November 2024-December 2027 |
| Morbidity after surgical resection | 90-day postoperative major morbidity (Clavien-Dindo ≥ grade3) of ≤40% | From November 2024-December 2027 |
| Number of patients evaluated at national MDT undergoing resection | From November 2024-December 2027 |
| Adverse events | Adverse events during primary chemotherapy | From November 2023-December 2027 |
| R0 resection rate | R0 (microscopic radical resection >1mm) versus R1 (microscopic residual tumor ≤1mm). | From November 2023-December 2027 |
| Quality of life EORTC QLQ-C30 | Outcome measures will be calculated, according to the validated questionnaire manuals. | Measured at baseline, 3, 6, and 12 months from diagnosis, followed by yearly measurements.] |
| Quality of life EORTC QLQ-PAN26 | Outcome measures will be calculated, according to the validated questionnaire manuals. | Measured at baseline, 3, 6, and 12 months from diagnosis, followed by yearly measurements. |
| Quality of life EQ-5D-5L | Outcome measures will be calculated, according to the validated questionnaire manuals. | Measured at baseline, 3, 6, and 12 months from diagnosis, followed by yearly measurements. |
|
| From November 2023-December 2027 |
| Stavanger University Hospital | Not yet recruiting | Stavanger | Norway | 4068 | Norway |
|
| University Hospital of North Norway | Not yet recruiting | Tromsø | Norway | 9038 | Norway |
|
| St. Olavs Hospital, Trondheim University Hospital | Not yet recruiting | Trondheim | Norway | 7006 | Norway |
|
| Oslo University Hospital | Recruiting | Oslo | 0424 | Norway |
|
| Background |
| 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. |
| 38036745 | Background | 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. |
| 38155512 | Background | 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. |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D003952 | Diagnostic Imaging |
| D014057 | Tomography, X-Ray Computed |
| D010180 | Pancreatectomy |
| D004724 | Endoscopy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D007090 | Image Interpretation, Computer-Assisted |
| D011856 | Radiographic Image Enhancement |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011859 | Radiography |
| D014056 | Tomography, X-Ray |
| D014054 | Tomography |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D003949 | Diagnostic Techniques, Surgical |
| D019060 | Minimally Invasive Surgical Procedures |
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