Comparing chemotherapy before and after surgery for pancreatic cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial investigates the effectiveness of neoadjuvant chemotherapy using FOLFIRINOX compared to adjuvant chemotherapy in patients with resectable pancreatic cancer. The goal is to determine if administering chemotherapy before surgery can improve surgical outcomes and overall survival rates by addressing undetected metastatic lesions and ensuring more patients complete their treatment. The study focuses on Asian populations to tailor chemotherapy dosing and efficacy based on their specific characteristics. It aims to provide insights into the optimal timing of chemotherapy for better patient outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• Department of Internal Medicine, Seoul St. Mary's Hospital, Catholic University College of Medicine
  Seoul, South Korea Recruiting
• Department of Surgery, Seoul National University College of Medicine
  Seoul, South Korea Recruiting

Study contacts

• Study coordinator: Jin-Young Jang
• Email: jyjang4@snu.ac.kr
• Phone: +82-2-2072-2194

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.