Nordic Pancreatic Cancer Trial (NorPACT) - 1

Sponsor
Oslo University Hospital
Study ID
NCT02919787
Phase
PHASE2/PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 5-FU — DRUG
    Neoadjuvant treatment
  • Oxaliplatine — DRUG
    Neoadjuvant treatment
  • Irinotecan — DRUG
    Neoadjuvant treatment
  • Pancreatic surgery — PROCEDURE
    All patients
  • 5-FU — DRUG
    Adjuvant treatment
  • Oxaliplatine — DRUG
    Adjuvant treatment
  • Irinotecan — DRUG
    Adjuvant treatment

Study Details

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

Key Dates

Start date
Sep 30, 2016
Status verified
Nov 2024
Primary completion
Dec 22, 2022
Completion
Apr 30, 2026

Study Design

Enrollment
140 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Surgery and then postoperative adjuvant chemotherapy
    Surgery and then postoperative adjuvant chemotherapy
  • Experimental: Neoadjuvant chemotherapy, surgery, adjuvant chemotherapy
    Neoadjuvant chemotherapy, surgery, adjuvant chemotherapy

Primary Outcome Measure

Overall survival 18 month after randomization [ Time Frame: 18 month ]

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