NeoFOL-R Trial (Perioperative Versus Adjuvnat FOLFIRINOX in Resectable Pancreatic Cancer)

Launched by SEOUL NATIONAL UNIVERSITY HOSPITAL · Sep 2, 2022

Keywords

ClinConnect Summary

The NeoFOL-R Trial is studying the best way to treat patients with resectable pancreatic cancer, which means the cancer can be surgically removed. Specifically, the trial is comparing two treatment approaches: one group of patients will receive a combination of chemotherapy before and after surgery (called neoadjuvant and adjuvant mFOLFIRINOX), while another group will only have chemotherapy after surgery. The main goal is to see which method helps patients live longer.

To be eligible for this trial, participants need to be between 19 and 80 years old, have a specific type of pancreatic cancer that can be surgically removed, and should be in good overall health with no other serious medical conditions. Patients will be monitored throughout the trial to ensure their safety and to see how well the treatments work. It's important for potential participants to know that those who join will be randomly assigned to one of the two treatment groups, and they will need to provide consent to take part in this study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • - A. Age: 19 to 80 years old B. Patients with a score of 0 - 1 (ECOG) when selecting a study subject C. Pancreatic ductal adenocarcinoma diagnosed by histological examination (histologic or cytopathological) D. Patients evaluated as resectable pancreatic cancer in preoperative imaging as follows (NCCN guidelines for pancreatic adenocarcinoma version 2.2021)
• • No arterial tumor contact (celiac asix, superior mesenteric artery, or common hepatic artery).
• • No tumor contact with the superior mesenteric vein or portal vein or ≤ 180°contact without vein contour irregularity.
• • E. No distant metastases on preoperative imaging F. Patients with adequate organ function
• • 1. Bone marrow function: WBC 3,000/mm3 or more or ANC 1,500/mm3 or more, platelet ≥ 100K/mm3
• • 2. Liver function: Bilirubin ≤ 3 x upper normal limit (≤5.0 mg/dL), AST/ALT ≤ 5 x upper normal limit (\<200 IU/L)
• • 3. Renal function (Cr clearance ≥ 60 mL/min) or (Cr \< 1.5 x upper normal limit) G. Persons physically capable of undergoing surgery H. Those who consented to the clinical trial I. Women of childbearing potential must have a negative serum pregnancy test within one week before starting the intervention drug. Men and women of childbearing potential must use effective contraception from screening through six months after the last dose.
• Exclusion Criteria:
• • - Patients who met any of the following criteria are not eligible to participate in this study.
• • A. Those evaluated as borderline resectable or locally advanced pancreatic cancer in preoperative imaging examination (The resectability assessment depends on the presence of major vessel invasion, while invasion of adjacent organs is excluded from the criteria) B. Patients with a history of previous pancreatic surgery C. Patients with a history of previous chemotherapy or radiation therapy for pancreatic cancer D. Patients with distant metastases or recurrent pancreatic cancer E. Pancreatic body or tail cancer requiring combined resection of adjacent organs (stomach or kidney) (except for the adrenal gland) F. 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) G. Pregnant and lactating women H. Serious concomitant systemic disorders, including active or ongoing systemic infections, symptomatic congestive heart failure, unstable angina, clinically significant cardiac arrhythmias, psychiatric disorders, or uncontrolled comorbid conditions that may limit compliance with study requirements, or any medical condition that, at the discretion of the investigator, could compromise patient safety, interfere with the assessment of safety and efficacy, or hinder participation in the clinical trial.