Perioperative or Adjuvant mFOLFIRINOX for Resectable Pancreatic Cancer (PREOPANC-3)

Erasmus University

Status and phase: Enrolling; Phase 3

Conditions: Resectable Pancreatic Adenocarcinoma; Pancreatic Ductal Adenocarcinoma; Pancreatic Cancer

Treatments: Drug: Oxaliplatin; Procedure: Resection; Drug: Fluorouracil; Drug: Irinotecan Hydrochloride; Drug: Leucovorin Calcium

Study type: Interventional

Funder types: Other

Identifiers

NCT04927780

MEC-2021-0002

2020-005141-16 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 378 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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378 participants in 2 patient groups

Arm 1: Perioperative mFOLFIRINOX

Experimental group

Description:

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.

Treatment:

Drug: Leucovorin Calcium

Drug: Irinotecan Hydrochloride

Drug: Fluorouracil

Procedure: Resection

Drug: Oxaliplatin

Arm 2: Adjuvant mFOLFIRINOX

Active Comparator group

Description:

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.

Treatment:

Drug: Leucovorin Calcium

Drug: Irinotecan Hydrochloride

Drug: Fluorouracil

Procedure: Resection

Drug: Oxaliplatin