A Phase 3 interventional study of Leucovorin Calcium and Fluorouracil in Pancreatic Cancer, Pancreatic Ductal Adenocarcinoma and Resectable Pancreatic Adenocarcinoma, sponsored by Erasmus Medical Center. Active, not recruiting at 21 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-15.
Sponsored by Erasmus Medical Center · Phase 3, Interventional, and Treatment
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.
3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.
This study's planned enrollment of 378 is above the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →Erasmus Medical Center is the lead sponsor of 466 studies on the registry; 179 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: Leucovorin Calcium · Drug: Fluorouracil · Drug: Irinotecan Hydrochloride · Drug: Oxaliplatin · Procedure: Resection
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.
Drug: Leucovorin Calcium · Drug: Fluorouracil · Drug: Irinotecan Hydrochloride · Drug: Oxaliplatin · Procedure: Resection
IV
IV
IV
IV
Open or minimally-invasive pancreatectomy.
Overall survival
The time between randomization and death from any cause. Patients alive at last follow-up are censored.
Time frame: Up to 5 years after randomization.
Progression free survival
The time between randomization and locoregional progressive disease before or during treatment (resulting in irresectability), the occurrence of distant metastases, recurrent pancreatic cancer after surgery or death from any cause. Patients alive and free of these events at last follow-up are censored.
Time frame: Up to 5 years after randomization.
Distant metastases free survival
The time between randomization and the occurrence of distant metastases or death from any cause. Patients alive and free of these events at last follow-up are censored.
Time frame: Up to 5 years after randomization.
Locoregional progression free survival
The time between randomization and locoregional progression before or during treatment (resulting in irresectability), locoregional recurrence after resection or death from any cause. Patients alive and free of these events at last follow-up are censored.
Time frame: Up to 5 years after randomization.
Distant metastases free interval
The time between randomization and the occurrence of distant metastases. Distant metastases are considered an event and patients are censored at death or last follow-up when without this event.
Time frame: Up to 5 years after randomization.
Locoregional progression free interval
The time between randomization and locoregional progression before or during treatment (resulting in irresectability), or locoregional recurrence after resection. Locoregional progressive disease before or during treatment or locoregional recurrence after resection are considered an event and patients are censored at death or last follow-up when free of these events.
Time frame: Up to 5 years after randomization.
Chemotherapy start rate
The percentage of patients who received at least one cycle of scheduled chemotherapy.
Time frame: 4 months
Number of chemotherapy cycles received.
The number of mFOLFIRINOX cycles patients received.
Time frame: 9 months
Chemotherapy completion rate
The percentage of patients who completed all cycles of scheduled chemotherapy.
Time frame: 9 months
Dose intensity
The amount of drug delivered as a percentage of planned dose according to the protocol.
Time frame: 9 months
Staging laparoscopy rate
The percentage of patients that actually underwent a staging laparoscopy, regardless whether a surgical exploration or resection was performed.
Time frame: At the time of surgery.
Laparoscopy yield
The percentage of patients that underwent staging laparoscopy and were diagnosed with metastatic or unresectable disease during this procedure.
Time frame: At the time of surgery.
Surgical exploration rate
The percentage of patients who underwent a surgical exploration (open or minimally-invasive), regardless whether a resection was performed.
Time frame: At the time of surgery.
Resection rate
The percentage of patients that underwent a curative-intent resection.
Time frame: At the time of surgery.
Microscopically margin-negative (R0) resection rate
The percentage of patients that underwent a microscopically margin-negative (R0) resection. The resection is considered R0 if there is no tumor within 1 mm of the margins.
Time frame: At the time of surgery.
Lymph node-negative (N0) resection rate
The percentage of patients that underwent a resection with negative lymph nodes (N0) in the surgical specimen.
Time frame: At the time of surgery.
Pathologic response
Tumor regression score in the surgical specimen
Time frame: At the time of surgery.
Adverse events as assessed by the CTCAE version 5.0
Adverse events are assessed during neoadjuvant therapy and adjuvant therapy.
Time frame: Until 30 days after last chemotherapy.
Postoperative complications
According to the Clavien-Dindo classification and by the International Study Group of Pancreatic Surgery and International Study Group of Liver Surgery.
Time frame: Up to 90 days after surgery.
Serum CA 19-9 and CEA response
The change in carbohydrate antigen 19-9 (CA 19-9) and carcinoembryonic antigen (CEA) after surgery and after 4, 8, and 12 cycles of mFOLFIRINOX compared to baseline.
Time frame: 9 months
Clinical response rate according to RECIST criteria version 1.1
Response comparing baseline and restaging after 4 and 8 cycles of mFOLFIRINOX
Time frame: At the time of surgery.
Patient reported cancer-specific health-related Quality of Life (HRQoL) as assessed using the EORTC QLQ-C30
At baseline and at 3, 6, 9, 12, 18 and 24 months and every subsequent year
Time frame: Up to 5 years after randomization.
Patient reported non-disease specific HRQoL as assessed using the EQ-5D-5L
At baseline and at 3, 6, 9, 12, 18 and 24 months and every subsequent year
Time frame: Up to 5 years after randomization.
Patient reported tumor-specific HRQoL as assessed using the EORTC LQPAN26
At baseline and at 3, 6, 9, 12, 18 and 24 months and every subsequent year
Time frame: Up to 5 years after randomization.
Patient reported Quality of Life as assessed using the worry of progression of cancer scale (WOPS)
At baseline and at 3, 6, 9, 12, 18 and 24 months and every subsequent year
Time frame: Up to 5 years after randomization.
Patient reported chemotherapy-induced peripheral neuropathy as assessed using the EORTC QLQ-CIPN20
At baseline and at 3, 6, 9, 12, 18 and 24 months and every subsequent year
Time frame: Up to 5 years after randomization.
Patient reported Quality of Life as assessed using the happiness, hospital, anxiety and depression scale (HADS)
At baseline and at 3, 6, 9, 12, 18 and 24 months and every subsequent year
Time frame: Up to 5 years after randomization.
Patient reported Quality of Life as assessed using Exocrine Pancreatic Insufficiency (EPI) questionnaire
At baseline and at 3, 6, 9, 12, 18 and 24 months and every subsequent year
Time frame: Up to 5 years after randomization.
Plan to share: Yes
This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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