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

Seoul National University Hospital0 个研究点目标入组 609 人开始时间: 待定最近更新: 2023年5月2日

试验速览

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•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

•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

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