Perioperative versus adjuvant FOLFIRINOX for resectable pancreatic cancer: the PREOPANC-3 study.

Surgical resection followed by chemotherapy (preferably mFOLFIRINOX) is the standard of care for primary resectable pancreatic cancer.

However, 50% of patients never receive chemotherapy due to postoperative complications, clinical deterioration or early recurrence.

By changing treatment strategy, neoadjuvant therapy (i.e. before surgery) could ensure early treatment of micro-metastases, improve the microscopically margin-negative resection rate, and identify patients with rapidly progressive disease who will be spared futile surgery.

Population: PREOPANC-3 is an international multicenter randomized trial investigating whether perioperative mFOLFIRINOX is superior to adjuvant mFOLFIRINOX in patients with resectable pancreatic cancer.

Intervention: Patients in the intervention arm receive 8 cycles of neoadjuvant mFOLFIRINOX followed by surgical resection and 4 cycles of adjuvant mFOLFIRINOX.

Control: Patients in the comparator arm undergo surgical resection followed by 12 cycles of adjuvant mFOLFIRINOX, i.e. the standard of care. Outcome: The primary endpoint is overall survival (intention-to-treat). Secondary endpoints include progression free survival, chemotherapy completion rate, and quality of life.

We will include 378 patients, of which >50 in Sweden, according to a power calculation for the primary endpoint.

All patients receive routine follow-up for five years, including outpatient clinic visits, CT scans, and blood collection.