NL-OMON54274招募中3 期
Perioperative versus adjuvant FOLFIRINOX for resectable pancreatic cancer: the PREOPANC-3 study. - PREOPANC-3
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 303
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •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.
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.
研究者
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