Perioperative versus adjuvant FOLFIRINOX for resectable pancreatic cancer: the PREOPANC-3 study. - PREOPANC-3

Erasmus MC0 个研究点目标入组 378 人开始时间: 2021年1月5日最近更新: 2022年4月4日

适应症

试验速览

暂无简介。

•Histologically or cytologically (Bethesda 5 or 6) confirmed pancreatic ductal adenocarcinoma.
•Resectable tumor according to DPCG criteria: no arterial contact and venous contact with the superior mesenteric vein or portal vein of 90 degrees or less
•No evidence for metastatic disease*
•WHO performance status of 0 or 1
•Ability to undergo surgery and mFOLFIRINOX chemotherapy
•Leucocytes (WBC) = 3.0 X 109/L
•Platelets = 100X 109/L
•Hemoglobin = 6.0 mmol/l
•Renal function: eGFR = 40 ml/min
•Age = 18 years
•Written informed consent
•* Lesions on chest CT that are too small to characterize are not considered metastatic disease.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 189
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 189

•Prior radiotherapy, chemotherapy, or surgery for pancreatic cancer.
•Prior chemotherapy precluding mFOLFIRINOX.
•Previous malignancy (excluding non-melanoma skin cancer, pancreatic neuroendocrine tumor (pNET) <2cm, and gastrointestinal stromal tumor (GIST) <2cm), unless no evidence of disease and diagnosed more than 3 years before diagnosis of pancreatic cancer, or with a life expectancy of more than 5 years from date of inclusion.
•Pregnancy or lactation.
•Serious concomitant systemic disorders that would compromise the safety of the patient or his/her ability to complete the study, at the discretion of the investigator.

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