drugset / Trial / NCT02919787
Nordic Pancreatic Cancer Trial (NorPACT) - 1
Phase 2/3
Active not recruiting
140 enrolled
Oslo University Hospital
Haukeland University Hospital · collabHelse Stavanger HF · collabHelsinki University Hospital, Finland · collabKarolinska University Hospital · collabLund University Hospital · collabNorrlands University Hospital · collabOdense University Hospital · collabSahlgrenska University Hospital · collabSt. Olavs Hospital · collabUniversity Hospital of North Norway · collabUniversity Hospital, Linkoeping · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
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
Timeline
- Start
- 2016-09
- Primary completion
- 2022-12-22
- Completion
- 2026-04-30
Outcome
Missed primary endpoint
paper 60% (95% CI 49-71) in the neoadjuvant FOLFIRINOX group versus 73% (62-84) in the upfront surgery group (p=0·032) PMID 38237621 ↗
Publications
- Results Labori 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.
- Labori 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Irinotecan | Small molecule | 150 mg/m2 | — |
| Subject | Irinotecan | Small molecule | 180 mg/m2 | — |
| Subject | Oxaliplatin | Small molecule | 85 mg/m2 | — |
| Subject | fluorouracil | Small molecule | 2400 mg/m2 | — |