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Neoadjuvant FOLFIRINOX versus upfront surgery for resectable pancreatic head cancer : a multicentre, randomised, phase 2 trial (Nordic Pancreatic Cancer Trial (NORPACT) – 1

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-517719-65-00
Acronym
NORPACT-1
Enrollment
131
Registered
2024-11-11
Start date
2017-02-01
Completion date
Unknown
Last updated
2024-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Resectable pancreatic head cancer

Brief summary

Overall survival at 18 months after the date of randomisation

Detailed description

Progression-free survival assessed at both 18 months and as time since randomisation,, Overall mortality at 1 year after commencement of allocated treatment for patients who ultimately underwent resection, Overall survival in both the intention-to-treat (ITT) and per-protocol populations, Overall survival and overall survival following resection, Histopathological response (R0 resection and [y]pN0 disease), Compliication rates at 90 days after surgery, Feasibility of neoadjuvant and adjuvant chemotherapy (as assessed by adverse events, dose reductions, and dose delays),, Completion rates of all parts of multimodal treatment, Health economics, Quality of life

Interventions

DRUGFLUOROURACIL
DRUGGEMCITABINE
DRUGIRINOTECAN
DRUGCAPECITABINE
DRUGOXALIPLATIN
DRUGCALCIUM FOLINATE

Sponsors

Oslo University Hospital HF
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Overall survival at 18 months after the date of randomisation

Secondary

MeasureTime frame
Progression-free survival assessed at both 18 months and as time since randomisation,, Overall mortality at 1 year after commencement of allocated treatment for patients who ultimately underwent resection, Overall survival in both the intention-to-treat (ITT) and per-protocol populations, Overall survival and overall survival following resection, Histopathological response (R0 resection and [y]pN0 disease), Compliication rates at 90 days after surgery, Feasibility of neoadjuvant and adjuvant chemotherapy (as assessed by adverse events, dose reductions, and dose delays),, Completion rates of all parts of multimodal treatment, Health economics, Quality of life

Countries

Norway, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026