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

Epworth HealthCare0 个研究点目标入组 100 人开始时间: 2024年1月8日最近更新: 2024年8月19日

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•Patients must meet all of the following criteria to participate in this study.
•1.Age: 18 – 80 years
•2.Patients with an Eastern Cooperative Oncology Group (ECOG) score of 0 – 2
•3.Pancreatic ductal adenocarcinoma diagnosed by histological examination (histologic or cytopathological)
•4.Patients evaluated for resectable pancreatic cancer on preoperative imaging as follows (NCCN guidelines for pancreatic adenocarcinoma version 2.2021)
•a.There is no arterial tumour contact (celiac artery, superior mesenteric artery, or common hepatic artery).
•b.There is no tumour contact with the superior mesenteric vein 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
•a)Bone marrow 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
•b)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)
•c)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

•Patients who meet any of the following criteria are not eligible to participate in this study.
•1)Those evaluated as borderline resectable or locally advanced pancreatic cancer in preoperative imaging examination
•2)Patients with a history of previous pancreatic surgery
•3)Patients with a history of previous chemotherapy or radiation therapy for pancreatic cancer
•4)Patients with distant metastases or recurrent pancreatic cancer
•5)Pancreatic body or tail cancer requiring combined resection of adjacent organs (stomach or kidney) (except for the adrenal gland)
•6)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)
•7)Pregnant and lactating women
•8)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

发起方

Epworth HealthCare