Neoadjuvant FOLFIRINOX in Resectable Pancreatic Cancer
Status:
Not yet recruiting
Trial end date:
2027-12-01
Target enrollment:
Participant gender:
Summary
Rationale: Adjuvant chemotherapy after surgery significantly improved the survival of PC
patients, but there is a problem that only about 50% of patients start adjuvant chemotherapy
after pancreatectomy. Neoadjuvant chemotherapy might control potential metastatic lesion
which are not being detected in early diseases status and improve the R0 resection rate. In
addition, it prevents futile surgery by selecting patients with rapid progression of disease.
Furthermore, compared to chemotherapy administered after surgery, more patients can complete
the planned chemotherapy schedule in neoadjuvant setting. Asians differ from Westerners not
only in racial differences, but also in average size and body surface area. Accordingly,
there is an urgent need for clinical studies on the dose, toxicity, dosing cycle, and
efficacy of anticancer drugs that reflect actual clinical trials in Asian countries for
Asians. There are still few studies worldwide that prospectively explored the efficacy of
neoadjuvant chemotherapy in resectable PC and the administration of neoadjuvant therapy in
resectable PC depends on individual clinical judgment. Therefore, systematic and prospective
clinical trials are essential to standardize treatment protocol in resectable PC.
Obective: To investigate whether 6 cycles of preoperative mFOLFIRINOX - surgery - 6 cycles of
postoperative mFOLFIRINOX improves overall survival by intention-to-treat compared to surgery
followed by 12 cycles of postoperative mFOLFIRINOX.
Study design: open-label, multicenter, randomized, phase 3 clinical trial Study population:
Patients with resectable pancreatic cancer and ECOG performance 0 or 1.
Intervention:
Invervention arm : 6 cycles of neoadjuvant mFOLFIRINOX followed by surgical resection and 6
cycles of adjuvant mFOLFIRINOX Comparator arm : surgical resection followed by 12 cycles of
adjuvant mFOLFIRINOX Primary endpoint: 2-year overall survival rate by intention-to-treat
Phase:
Phase 3
Details
Lead Sponsor:
Seoul National University Hospital
Collaborators:
Gangnam Severance Hospital Seoul National University Bundang Hospital Seoul St. Mary's Hospital SMG-SNU Boramae Medical Center