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Nordic Pancreatic Cancer Trial (NorPACT) - 1

StatusActive, Not Recruiting
PhasePhase 2/3
Started2016-09
View on ClinicalTrials.gov ↗

Amendment history

2024-11-18
Study Status, Sponsor/Collaborators, Oversight, Contacts/Locations, References v9
Study sites13 entries, revised
PerOdense PfeifferUniversity Hospital VilleHelsinki SallinenUniversity Hospital
Collaborators4 to 11 entries
Sahlgrenska University Hospital Karolinska University Hospital University Hospital, Linkoeping Lund University Hospital Odense University Hospital Helsinki University Hospital, Finland Norrlands University Hospital
Publicationsdetails revised at 1 of 2 entries
2023-02-09
Study Status v8
Primary completion dateestimated 2022-12-31→confirmed 2022-12-22
2022-09-26
Study Status v7
Primary completion date2022-10→2022-12-31
Completion date2026-04→2026-04-30
2021-06-25
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v6
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2021-10→2022-10
Completion date2022-10→2026-04
Study sitesdetails revised at 13 of 13 sites
2020-12-28
Study Status, Study Design v5
Enrollment target130→140
Show 4 earlier versions
2020-06-05
Study Identification, Study Status, Sponsor/Collaborators, Study Design, Outcome Measures, Contacts/Locations v4
Enrollment target90→130
Study sites1→13
Secondary endpoints2 to 7 entries
Overall mortality at one year following commencement of allocated treatment. Disease-free survival Histopathological response Complication rate after date of randomization (intention to treat)surgery Feasibility of neoadjuvant and adjuvant chemotherapy Health (Commonrelated TerminologyQuality Criteriaof forLife Health Adverse Events, grade 3-5, dose reduction, dose delay)economics
Primary endpoints1 entry, revised
Overall survival one18 yearmonth after resectionrandomization
Study title-3 characters
NorwegianNordic Pancreatic Cancer Trial (NorPACT) - 1
2019-11-25
Study Status, Arms and Interventions v3
Interventions5-FU (Drug), Capecitabine (Drug), Gemcitabine (Drug), Irinotecan (Drug), Oxaliplatine (Drug), Pancreatic surgery (Procedure)→5-FU (Drug), 5-FU (Drug), Irinotecan (Drug), Irinotecan (Drug), Oxaliplatine (Drug), Oxaliplatine (Drug), Pancreatic surgery (Procedure)
2019-03-12
Study Status v2
Re-verified, no change to tracked fields
2017-10-19
Study Status, Contacts/Locations v1
Study sitesdetails revised at 1 of 1 site
2016-09-28
Original filing
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
Trial Details
NCT Number NCT02919787
Lead Sponsor Oslo University Hospital
Collaborators: St. Olavs Hospital, Haukeland University Hospital, University Hospital of North Norway, Sahlgrenska University Hospital, Karolinska University Hospital, University Hospital, Linkoeping, Lund University Hospital, Odense University Hospital, Helsinki University Hospital, Finland, Norrlands University Hospital, Helse Stavanger HF
Conditions Pancreatic Cancer
Enrollment 140 participants
Start Date 2016-09
Primary Completion 2022-12-22 (estimated)
Study Completion 2026-04-30 (estimated)
Updated on ClinicalTrials.gov 2024-11-20