2024-510617-15-00招募中3 期
Perioperative versus adjuvant FOLFIRINOX for resectable pancreatic cancer: the PREOPANC-3 study
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)22 个研究点 分布在 2 个国家目标入组 378 人开始时间: 2024年9月6日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 378
- 试验地点
- 22
- 主要终点
- Primary endpoint is overall survival by intention to treat
研究概览
简要总结
Investigate whether perioperative mFOLFIRINOX improves overall survival compared to adjuvant mFOLFIRINOX in resectable pancreatic cancer.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically (Bethesda 5 or 6) confirmed pancreatic ductal adenocarcinoma
- •Age ≥ 18 years
- •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
排除标准
- •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
结局指标
主要结局
Primary endpoint is overall survival by intention to treat
Primary endpoint is overall survival by intention to treat
次要结局
未报告次要终点
研究者
Secretariat HPB
Scientific
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
研究点 (22)
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