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This is a Norwegian prospective observational study that evaluates the resectability rate in patients with borderline resectable and locally advanced pancreatic cancer who received neoadjuvant chemotherapy in a population based cohort. Eligible patients are treated with neoadjuvant 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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Folfirinox | Drug | Neoadjuvant chemotherapy is given according to different regimens, preferably FOLFIRINOX according to the recommendations in the national Norwegian guidelines. The choice of chemotherapy regimen is decided by the treating oncologist. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of resectability in both groups (borderline and locally advanced pancreatic cancer) | Patients who undergo surgical resection will be documented | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival from time of inclusion (intention to treat) | Overall survival rate at 5 years using Kaplan-Meier survival analysis | |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | 1 year after inclusion |
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Inclusion Criteria:
Exclusion Criteria:
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Population based cohort from a universal health care system
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| Name | Affiliation | Role |
|---|---|---|
| Knut J. Labori, MD, PhD | Oslo University Hospital, Oslo, Norway | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo University Hospital | Oslo | 0268 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38957079 | Result | Farnes I, Lund-Iversen M, Aabakken L, Verbeke C, Labori KJ. Molecular testing for personalized therapy is underutilized in patients with borderline resectable and locally advanced pancreatic cancer - real world data from the NORPACT-2 study. Scand J Gastroenterol. 2024 Sep;59(9):1093-1096. doi: 10.1080/00365521.2024.2373115. Epub 2024 Jul 3. | |
| 38126766 |
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| Overall survival following resection | Overall survival rate at 5 years using Kaplan-Meier survival analysis |
| Overall survival after 1, 2, 3 and 5 years | 1, 2, 3 and 5 years after inclusion |
| 1-year progression-free survival rate | 1-year after surgical resection |
| Disease-free survival | Disease-free survival at 5 years using Kaplan-Meier survival analysis |
| Radiological response | 2-6 months after initiation of chemotherapy |
| Histopathological response | 14-30 days post surgery |
| R0 resection rate | 14-30 days post surgery |
| Complication rates after surgery classification systems) | Dindo-Clavien and ISPGS | 30 and 90 days post surgery |
| Completion rates of all parts of multimodal treatment | Up to 1 year after inclusion |
| QoL (EORTC QLQ-30) | 5 years |
| Performance status - Eastern Cooperative Oncology Group (ECOG) | 0 - Asymptomatic (Fully active, able to carry on all predisease activities without restriction)
| 5 years |
| Farnes I, Paulsen V, Verbeke CS, Tonnesen CJ, Aabakken L, Labori KJ. Performance and safety of diagnostic EUS FNA/FNB and therapeutic ERCP in patients with borderline resectable and locally advanced pancreatic cancer - results from a population-based, prospective cohort study. Scand J Gastroenterol. 2024 Apr;59(4):496-502. doi: 10.1080/00365521.2023.2290456. Epub 2023 Dec 21. |
| 38155512 | Result | 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 |
|---|---|
| C000627770 | folfirinox |
| D000093542 | Gemcitabine |
| D005472 | Fluorouracil |
| D002955 | Leucovorin |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
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