drugset / Trial / NCT04927780
Perioperative or Adjuvant mFOLFIRINOX for Resectable Pancreatic Cancer
Phase 3
Active not recruiting
378 enrolled
Erasmus Medical Center
Dutch Cancer Society · collabDutch Pancreatic Cancer Group · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2021-09-07
- Primary completion
- 2027-01
- Completion
- 2029-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Irinotecan | Small molecule | 150 mg/m2 | — |
| Subject | Leucovorin | Small molecule | 400 mg/m2 | — |
| Subject | Oxaliplatin | Small molecule | 85 mg/m2 | — |
| Subject | fluorouracil | Small molecule | 2.4 g | Intravenous |