Efficacy of neoadjuvant FOLFIRINOX in resectable pancreatic cancer: an international multicenter randomized controlled trial

Not Applicable

Conditions: Neoplasms

Registration Number: KCT0008360

Lead Sponsor: Seoul National University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot yet recruiting

Sex: All

Target Recruitment: 609

Inclusion Criteria

A. Age: 18 – 80 years
B. Patients with an Eastern Cooperative Oncology Group (ECOG) score of 0 – 2
C. Pancreatic ductal adenocarcinoma diagnosed by histological examination (histologic or cytopathological)
D. Patients evaluated for resectable pancreatic cancer on preoperative imaging as follows (NCCN guidelines for pancreatic adenocarcinoma version 2.2021)
?There was no arterial tumor contact (celiac artery, superior mesenteric artery, or common hepatic artery).
?There was 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
a) Bone marrow function: WBC = 3,000/mm3 or absolute neutrophil count (ANC) = 1,500/mm3, platelet = 100 K/mm3
b) Liver function: bilirubin = 3 × the upper normal limit (= 5.0 mg/dL), AST/ALT = 5 the upper normal limit (< 200 IU/L)
c) Renal function (Creatinine clearance (Cr) = 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

Exclusion Criteria

A. Those evaluated as borderline resectable or locally advanced pancreatic cancer in preoperative imaging examination
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 that would compromise the safety of the patient or patient's ability to complete the study at the discretion of the investigator

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
2-year survival rate

Secondary Outcome Measures

Name	Time	Method
Overall survival;Resection rate;R0 resection rate;Disease-free survival;Recurrence rate;Response rate in the neoadjuvant setting;lymph node negative resection rate