Clinical trial · Interventional
Nordic Pancreatic Cancer Trial (NorPACT) - 1
Nordic Multicentre Un-blinded Phase II Randomized Controlled Trial (RCT) Evaluating the Additional Efficacy of Adding Chemotherapy Prior to Resection of a Pancreatic Head Malignancy to Avoid Early Mortality in Those Ultimately Resected
NCT02919787CI-TRIAL-00082748active not recruitingPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- 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 study evaluate the additional effect of adding chemotherapy prior to resection of a pancreatic head malignancy. The patients will be randomized into two groups; surgery first (control group) and neoadjuvant chemotherapy (intervention). Primary endpoint is overall survival after resection
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-FU | Drug | Fluorouracil | ALIAS |
| Irinotecan | Drug | Irinotecan | ALIAS |
| Oxaliplatine | Drug | Oxaliplatin | ALIAS |
| Pancreatic surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Surgery and then postoperative adjuvant chemotherapy
- description
- Surgery and then postoperative adjuvant chemotherapy
- interventionNames
- Procedure: Pancreatic surgery
- Drug: 5-FU
- Drug: Oxaliplatine
- Drug: Irinotecan
- type
- EXPERIMENTAL
- label
- Neoadjuvant chemotherapy, surgery, adjuvant chemotherapy
- description
- Neoadjuvant chemotherapy, surgery, adjuvant chemotherapy
- interventionNames
- Drug: 5-FU
- Drug: Oxaliplatine
- Drug: Irinotecan
- Procedure: Pancreatic surgery
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Resectable adenocarcinoma of the pancreatic head * T1-3, Nx, M0 (UICC 7th version, 2010) * Cytologic or histologic 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 pancreaticoduodenectomy * Chronic neuropathy ≥ grade 2 * WHO performance score \> 2 • Granulocyte count \< 1500 per cubic millimetre * Platelet count \< 100 000 per cubic millimeter * 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 organic disorders which could interfere with informed consent or treatments * Other malignancy within the past 5 years, except non-melanomatous skin or non-invasive cervical cancer * Percutaneous tumor biopsy * Any reason why, in the opinion of the investigator, the patient should not participate * Pregnancy * Breastfeeding
References
Publications (2)
- RESULTLabori KJ, Bratlie SO, Andersson B, Angelsen JH, Biorserud C, Bjornsson B, Bringeland EA, Elander N, Garresori H, Gronbech JE, Haux J, Hemmingsson O, Liljefors MG, Myklebust TA, Nymo LS, Peltola K, Pfeiffer P, Sallinen V, Sandstrom P, Sparrelid E, Stenvold H, Soreide K, Tingstedt B, Verbeke C, Ohlund D, Klint L, Dueland S, Lassen K; Nordic Pancreatic Cancer Trial-1 study group. Neoadjuvant FOLFIRINOX versus upfront surgery for resectable pancreatic head cancer (NORPACT-1): a multicentre, randomised, phase 2 trial. Lancet Gastroenterol Hepatol. 2024 Mar;9(3):205-217. doi: 10.1016/S2468-1253(23)00405-3. Epub 2024 Jan 15. PMID 38237621
- DERIVEDLabori KJ, Lassen K, Hoem D, Gronbech JE, Soreide JA, Mortensen K, Smaaland R, Sorbye H, Verbeke C, Dueland S. Neoadjuvant chemotherapy versus surgery first for resectable pancreatic cancer (Norwegian Pancreatic Cancer Trial - 1 (NorPACT-1)) - study protocol for a national multicentre randomized controlled trial. BMC Surg. 2017 Aug 25;17(1):94. doi: 10.1186/s12893-017-0291-1. PMID 28841916