Perioperative or Adjuvant mFOLFIRINOX for Resectable Pancreatic Cancer

Sponsor
Erasmus Medical Center
Study ID
NCT04927780
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Leucovorin Calcium — DRUG
    IV
  • Fluorouracil — DRUG
    IV
  • Irinotecan Hydrochloride — DRUG
    IV
  • Oxaliplatin — DRUG
    IV
  • Resection — PROCEDURE
    Open or minimally-invasive pancreatectomy.

Study Details

The PREOPANC-3 study is a randomized, multicenter, phase 3 trial. Patients with resectable pancreatic cancer will be randomly assigned (1:1) to 8 cycles of neoadjuvant mFOLFIRINOX followed by surgery and 4 cycles of adjuvant mFOLFIRINOX (arm 1) or to upfront surgery followed by 12 cycles of adjuvant mFOLFIRINOX (arm 2). The primary objective of the trial is to determine whether perioperative mFOLFIRINOX improves overall survival compared with adjuvant mFOLFIRINOX in patients with resectable pancreatic cancer.

Key Dates

Start date
Sep 7, 2021
Status verified
May 2026
Primary completion
Jan 31, 2027
Completion
Jul 31, 2029

Study Design

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

Arms

  • Experimental: Arm 1: Perioperative mFOLFIRINOX
    Patients in the intervention arm (arm 1) start with neoadjuvant mFOLFIRINOX (consisting of oxaliplatin 85 mg/m², irinotecan 150 mg/m², leucovorin 400 mg/m², all at day 1, and fluorouracil continuous IV infusion 2.4 g/m² over 46 hours). Cycles are repeated every 14 days. After eight cycles, surgical resection is performed in the absence of unresectable or metastatic disease. After resection, four cycles of adjuvant mFOLFIRINOX are scheduled.
  • Active Comparator: Arm 2: Adjuvant mFOLFIRINOX
    Patients in the comparator arm (arm 2) start with surgery. After resection, 12 cycles of adjuvant mFOLFIRINOX (consisting of oxaliplatin 85 mg/m², irinotecan 150 mg/m², leucovorin 400 mg/m², all at day 1, and fluorouracil continuous IV infusion 2.4 g/m² over 46 hours) are scheduled.

Primary Outcome Measure

Overall survival [ Time Frame: Up to 5 years after randomization. ]

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