Perioperative Versus Adjuvant FOLFIRINOX for Resectable Pancreatic Cancer: the PREOPANC-3 Study

Trial ID: NCT04927780

Interventional - Phase 3 - Active, not recruiting

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.

Conditions

• Pancreatic Cancer
• Pancreatic Ductal Adenocarcinoma
• Resectable Pancreatic Adenocarcinoma

Interventions

• Leucovorin Calcium
• Fluorouracil
• Irinotecan Hydrochloride
• Oxaliplatin
• Resection

Eligibility

Inclusion criteria

• Histologically or cytologically (Bethesda 5 or 6) confirmed pancreatic ductal adenocarcinoma.
• Resectable tumor according to Dutch Pancreatic Cancer Group criteria: no arterial contact and venous contact with the superior mesenteric vein or portal vein of 90 degrees or less
• No evidence for metastatic disease
• WHO performance status of 0 or 1
• Ability to undergo surgery and mFOLFIRINOX chemotherapy
• Leucocytes (WBC) ≥ 3.0 x 10\^9/L
• Platelets ≥ 100 x 10\^9/L
• Hemoglobin ≥ 6.0 mmol/l
• Renal function: eGFR ≥ 40 ml/min
• Age ≥ 18 years
• Written informed consent

Exclusion criteria

• Prior radiotherapy, chemotherapy, or surgery for pancreatic cancer.
• Prior chemotherapy precluding mFOLFIRINOX.
• Previous malignancy (excluding non-melanoma skin cancer, pancreatic neuroendocrine tumor (pNET) \<2cm, and gastrointestinal stromal tumor (GIST) \<2cm), unless no evidence of disease and diagnosed more than 3 years before diagnosis of pancreatic cancer, or with a life expectancy of more than 5 years from date of inclusion.
• Pregnancy or lactation.
• Serious concomitant systemic disorders that would compromise the safety of the patient or his/her ability to complete the study, at the discretion of the investigator.

Sponsor

Erasmus Medical Center, Dutch Pancreatic Cancer Group, Dutch Cancer Society

Source: ClinicalTrials.gov

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