Clinical trial · Observational
Neoadjuvant Chemotherapy in Borderline Resectable and Locally Advanced Pancreatic Cancer (NORPACT-2)
Neoadjuvant Chemotherapy in Borderline Resectable and Locally Advanced Pancreatic Cancer - A Norwegian Population Based Observational Study (NORPACT-2)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Borderline Resectable Pancreatic Adenocarcinoma | Pancreatic Adenocarcinoma | CURATED_BROADER | 0.78 |
| Chemotherapy Effect | — | UNRESOLVED | — |
| Locally Advanced Pancreatic Adenocarcinoma | Pancreatic Adenocarcinoma | CURATED_BROADER | 0.78 |
| Pancreatectomy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Folfirinox | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Rate of resectability in both groups (borderline and locally advanced pancreatic cancer)
- timeFrame
- 5 years
- description
- Patients who undergo surgical resection will be documented
Secondary outcomes (13)
- measure
- Overall survival from time of inclusion (intention to treat)
- timeFrame
- Overall survival rate at 5 years using Kaplan-Meier survival analysis
- measure
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
- timeFrame
- 1 year after inclusion
- measure
- Overall survival following resection
- timeFrame
- Overall survival rate at 5 years using Kaplan-Meier survival analysis
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * borderline resectable or locally advanced adenocarcinoma of the pancreas (NCCN, version 2, 2015) * Nx, M0 (UICC 8 th version, 2016) * cytological or histological confirmation of adenocarcinoma * age \> 18 year and considered fit for major surgery * written informed consent * considered able to receive the study-specific chemotherapy Exclusion Criteria: * co-morbidity precluding pancreatectomy * chronic neuropathy ≥ grade 2 * WHO performance score \> 2 * granulocyte count \< 1500 per cubic millimetre * platelet count \< 100 000 per cubic millimetre * serum creatinine \> 1.5 UNL (upper limit normal range) * albumin \< 2,5 g/dl * 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
References
Publications (3)
- RESULTFarnes 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. PMID 38957079
- RESULTFarnes 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. PMID 38126766
- RESULTFarnes 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. PMID 38155512