NL-OMON55463招募中3 期
The (cost)effectiveness of neoadjuvant FOLFIRINOX versus neoadjuvant gemcitabine based chemoradiotherapy and adjuvant gemcitabine for (borderline) resectable pancreatic cancer. - PREOPANC-2
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 368
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 confirmed pancreatic cancer (i.e. pancreatic
- •ductal adenocarcinoma)
- •(Borderline) resectable tumor without metastatic disease
- •WHO performance status 0 or 1
- •Ability to undergo surgery, chemoradiotherapy and chemotherapy
- •Leucocytes (WBC) >= 3.0 X 109/l (should be assesed within 4 weeks prior to
- •randomization)
- •Platelets >= 100X 109 /l (should be assesed within 4 weeks prior to
- •randomization)
- •Hemoglobin >= 6 mmol/l (should be assesed within 4 weeks prior to
- •randomization)
- •Renal function: E-GFR >= 50 ml/min (should be assesed within 4 weeks prior to
- •randomization)
- •Age >= 18 years
- •Written informed consent
排除标准
- •Prior radiotherapy, chemotherapy, or resection for pancreatic cancer.
- •Prior radiotherapy or chemotherapy precluding chemoradiotherapy or FOLFIRINOX.
- •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.
- •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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