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

ACTRN 12624000005550

Brief Summary

This project is investigating the use of chemotherapya cancer treatment that uses drugs to kill or slow the growth of cancer cells, while minimising damage to healthy cells drugs called mFOLFIRINOX in individuals with pancreatic cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs before surgerytreatment involving removal of cancerous tissue and/or tumours and a margin of healthy tissue around it to reduce recurrence, rather than the usual process of using these drugs after surgery.

Intervention/Treatment

• Drug: mFOLFIRINOX

Inclusion Criteria

Patients must meet all of the following criteria to participate in this study.

1. Age: 18 – 80 years.
2. Patients with an Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer Group (ECOG) score of 0 – 2.
3. Pancreatic ductal adenocarcinomacancer arising from mucus-producing glands in organs diagnosed by histological examination (histologic or cytopathological).
4. Patients evaluated for resectable pancreatic cancer on preoperative imagingtests that create detailed images of areas inside the body as follows (NCCN guidelines for pancreatic adenocarcinoma version 2.2021).
   • There is no arterial tumoura tissue mass that forms from groups of unhealthy cells contact (celiac arterya blood vessel that carries oxygenated blood from the heart to the rest of the body, superior mesenteric artery, or common hepatic artery).
   • There is no tumour contact with the superior mesenteric veina blood vessel that carries deoxygenated blood to the heart to get oxygen 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:
   • Bone marrowsoft, spongy tissue found in bones that makes blood cells 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.
   • 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).
   • 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.