Modified-FOLFIRINOX Regimen Based Neoadjuvant Therapy in Chinese Patients With Locally Advanced Pancreatic Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
FOLFIRINOX regimen is first-line neoadjuvant chemotherapies for patients with locally advanced pancreatic cancer (LAPC) worldwide. However, FOLFIRINOX is not well accepted in China because of the high prevalence of adverse events and poor tolerance. To evaluate the safety and efficacy of modified-FOLFIRINOX (mFOLFIRINOX) in Chinese LAPC patients and compare survival between LAPC patients with mFOLFIRINOX-based preoperative therapy and LAPC patients who underwent surgery alone.
详细描述
At this institution, a mFOLFIRINOX regimen has been adopted for metastatic pancreatic cancer (MPC) patients and promising results obtained. The modification resulted in a significantly reduced prevalence of severe adverse events in MPC patients, whereas the OS and PFS were extended to 10.3m and 7.0m, respectively, which is similar to that for patients on a full-dose regimen. Therefore, the investigators further evaluated the efficacy of mFOLFIRINOX in LAPC patients. Here, investigators want to prospectively enroll LAPC patients who underwent preoperative therapy with mFOLFIRINOX from April 2014 and compared the surgical resectability and surgical morbidity/surgical mortality among patients with surgically resectable pancreatic cancer (RPC) or LAPC who underwent surgery alone retrospectively. For patients with LAPC, mFOLFIRINOX was administrated for several cycles until the optimal response was obtained and then patients were evaluated for surgery. Moreover, survival data, including OS and PFS, were determined.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients are diagnosed by histology to have pancreatic adenocarcinoma
- •The patients are defined as locally advanced pancreatic cancer according to NCCN guideline
- •The patients prescribed mFOLFIRINOX-based neoadjuvant therapy
排除标准
- •ECOG performance score more than 2
- •Insufficient bone marrow, liver and renal function
- •Patients with other malignancies
- •Patients were older than 85 years or less than 18 years
研究组 & 干预措施
LAPC patients with mFOFLRINOX-based neoadjuvant therapy
LAPC patients were enrolled prospectively and diagnosed by MDT group in our hospital. These patients further received the neoadjuvant therapy with mFOLFIRINOX, the Overall survival, Progression survival, response to mFOLFIRINOX, chemo-related Toxicities, Postoperative complications and Histopathologic staging were measured.
干预措施: modified-FOLFIRINOX (Drug)
结局指标
主要结局
Overall survival
时间窗: 2014-04-01 to 2017-11-01
the duration from the date of hospital admission to death of any cause.
Progression free survival
时间窗: 2014-04-01 to 2017-11-01
the duration from the date of hospital admission to disease progression or death.
次要结局
- Postoperative complications(2014-04-01 to 2017-11-01)
- Histopathologic staging(2014-04-01 to 2017-11-01)
- Response to mFOLFIRINOX(2014-04-01 to 2017-11-01)
- mFOLFIRINOX related adverse events(2014-04-01 to 2017-11-01)