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RecruitingLast updated: 16 December 2025

NeoFOL-R: This trial is investigating the use of chemotherapy drugs (called mFOLFIRINOX) in people with pancreatic cancer before they have surgery, rather than the usual process of using these drugs after surgeryEfficacy of Neoadjuvant FOLFIRINOX in Resectable pancreatic cancer: An international multicenter Randomized, controlled trial (NeoFOL-R) - Australian protocol

Trial purpose

Medical clipboardCancer treatment

Tumor type

Upper gastrointestinal tract Cancers Upper gastrointestinal tract

Age

People18 - 80

Trial acronym

NeoFOL-R

Clinical summary

Summary

Eligible participants will be randomly allocated (by chance) to one of two treatment arms.

Participants allocated to Treatment Arm A will undergo surgery first, followed by 12 cycles of mFOLFIRINOX chemotherapy.

Participants allocated to Treatment Arm B will undergo 6 cycles of mFOLFIRINOX chemotherapy, followed by surgery, and will then complete the last 6 cycles of mFOLFIRINOX.

It is hoped this research will determine whether administering these chemotherapy drugs before surgery has a positive impact, including possibly shrinking tumours prior to surgery. If this study finds that pre-surgical chemotherapy is beneficial, this information could be used to improve outcomes for future pancreatic cancer patients.

Associated study

This record describes the Australian-specific protocol and recruitment sites for a multi-site international trial that has been registered with the Clinical Research Information Service (CRiS) of Republic of Korea - KCT0008360 ClinicalTrials.gov (NCT05529940).

Conditions

This trial is treating people with pancreatic cancer who are eligible for surgery

Eligibility

Inclusion

Patients must meet all of the following criteria to participate in this study.
1. Age: 18 – 80 years
2. Patients with an Eastern Cooperative Oncology Group (ECOG) score of 0 – 2
3. Pancreatic ductal adenocarcinoma diagnosed by histological examination (histologic or cytopathological)
4. Patients evaluated for resectable pancreatic cancer on preoperative imaging as follows (NCCN guidelines for pancreatic adenocarcinoma version 2.2021)
a. There is no arterial tumour contact (celiac artery, superior mesenteric artery, or common hepatic artery).
b. There is no tumour contact with the superior mesenteric vein or portal vein or equal to or less than 180°contact without vein contour irregularity.
5. No distant metastases on preoperative imaging
6. Patients with adequate organ function
a) Bone marrow function: WBC greater or equal to 3,000/mm3 or absolute neutrophil count (ANC) greater or equal to 1,500/mm3, platelet greater or equal to 100 K/mm3
b) Liver function: bilirubin equal or less than 3 × the upper normal limit (equal to or less than 5.0 mg/dL), AST/ALT equal to or less than 5 the upper normal limit (less than 200 IU/L)
c) Renal function (Creatinine clearance (Cr) equal to or greater than 60 mL/min) or (Cr < 1.5 x upper normal limit)
7. Persons physically capable of undergoing surgery
8. Those who consented to the clinical trial

Exclusion

Patients who meet any of the following criteria are not eligible to participate in this study.
1) Those evaluated as borderline resectable or locally advanced pancreatic cancer in preoperative imaging examination
2) Patients with a history of previous pancreatic surgery
3) Patients with a history of previous chemotherapy or radiation therapy for pancreatic cancer
4) Patients with distant metastases or recurrent pancreatic cancer
5) Pancreatic body or tail cancer requiring combined resection of adjacent organs (stomach or kidney) (except for the adrenal gland)
6) Patients within five years of diagnosis of other organ malignancies (with the exception of adequately treated non-melanoma skin cancer and carcinoma in situ without evidence of disease)
7) Pregnant and lactating women
8) Serious concomitant systemic disorders that would compromise the safety of the patient or patient's ability to complete the study at the discretion of the investigator

Inclusion

  • Your cancer has not spread to other parts of the body (localised).
  • You have been diagnosed with cancer, but have not received any treatment.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ANZCTR, ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

Epworth HealthCare

Scientific Title

Efficacy of Neoadjuvant FOLFIRINOX in Resectable pancreatic cancer: An international multicenter Randomized, controlled trial (NeoFOL-R) - Australian protocol

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