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

  • STATUS
    Recruiting
  • End date
    Jul 7, 2029
  • participants needed
    378
  • sponsor
    Erasmus Medical Center
Updated on 7 July 2022
pancreatectomy
fluorouracil
oxaliplatin
EGFR
leucovorin
irinotecan
cancer chemotherapy
adenocarcinoma
resectable pancreatic cancer
pancreatic ductal adenocarcinoma
breast ductal carcinoma

Summary

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.

Details
Condition Pancreatic Cancer, Pancreatic Ductal Adenocarcinoma, Resectable Pancreatic Adenocarcinoma
Treatment fluorouracil, Leucovorin calcium, Oxaliplatin, irinotecan hydrochloride, Resection
Clinical Study IdentifierNCT04927780
SponsorErasmus Medical Center
Last Modified on7 July 2022

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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