NCT02717091Unknown2 期
Phase II Study of Neoadjuvant FOLFIRINOX or Nab-paclitaxel With Gemcitabine for Borderline Resectable Pancreatic Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 50
- 主要终点
- R0 resection rate
研究概览
简要总结
The aim of this study is to clarify the efficacy and safety of neoadjuvant FOLFIRINOX and nab-paclitaxel + gemcitabine for borderline resectable pancreatic cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Borderline resectable pancreatic cancer (based on NCCN guideline version 2.2015)
- •first treatment for pancreatic cancer
- •performance status 0 or 1
- •adequate one marrow function
- •adequate renal function
- •obtained informed consent
排除标准
- •other active concomitant malignancies
- •other severe medical conditions; contraindication of FOLFIRINOX, paclitaxel and gemcitabine
- •pregnant women
- •no informed consent
研究组 & 干预措施
GEM + nab-PTX
Experimental
2 course of GEM + nab-PTX before surgery
干预措施: gemcitabine + nab-paclitaxel (Drug)
FOLFIRINOX
Experimental
4 course of FILFIRINOX before surgery
干预措施: FOLFIRINOX (Drug)
结局指标
主要结局
R0 resection rate
时间窗: 3 months
surgery is supposed to be performed 3 months after the initiation of chemotherapy
次要结局
- surgical complication(1 month after the surgery)
- relative dose intensity(3 months)
- tumor response(3 months)
- overall survival(3 years after the surgery)
- adverse event(3 months)
- disease free survival(3 years after the surgery)
- completion rate of chemotherapy(3 months)
- quality of the tumor(3 months)
研究者
Junpei Yamaguchi
Surgical Oncology
Nagoya University
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