Modified FOLFIRINOX for Gemcitabine Refractory Pancreatic Cancer: A Phase II Multicenter Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- True response rate
研究概览
简要总结
Pancreatic ductal adenocarcinoma is the fourth cause of death in the Western world. Surgery remains the only treatment offering an advantage in terms of overall survival (5-year survival range, 15-25%), but unfortunately only 10-20% of patients present resectable disease at the time of diagnosis. Since the approval of gemcitabine as a standard treatment for advanced pancreatic patients, no drug or combination of drugs has significantly improved the prognosis. Recently, as compared with gemcitabine, FOLFIRINOX was associated with a survival advantage (11.1 vs 6.8 months), but had increased toxicity. In some retrospective studies, modified FOLFIRINOX regimen (60/120 mg/m2 of oxaliplatin and irinotecan) has an improved safety profile in digestive malignancies. The purpose of this phase II multicenter study was to investigate the efficacy and safety in patients with pancreatic cancer who progressed in gemcitabine-based first line chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed pancreatic ductal adenocarcinoma (metastatic or locally advanced stage)
- •Refractory or progress to Gemcitabine based 1st line chemotherapy
- •Older than 19 years old and younger than 75 years old
- •Life expectancy> 3 months
- •ECOG Performance status ≤2
- •Only patients with measurable lesions in imaging study
- •Adequete BM function (WBC ≥ 3,500/µl, absolute neutrophil cell count ≥ 1,500 /µl, platelet count ≥ 100,000/µl)
- •Adequete liver function (total bilirubin < 1.5 X the upper limits of normal (ULN), AST and ALT <3 X UNL, and alkaline phosphatases < 3 X ULN or < 5 x ULN in case of liver involvement)
- •Adequete renal function (serum creatinine < 1.5 mg/dl)
- •Adequete cardiopulmonary function
排除标准
- •Pathologically confirmed another type of pancreatic cancer (except ductal adenocarcinoma)
- •Metastatic adenocarcinoma of originating at other organs
- •Evidence with CNS metastasis
- •Active infection
- •Uncontrolled serious medical or psychiatric illness which can induce toxicity ro complication of treatment, such as inability to swallow, lacking physical integrity of the gastrointestinal tract, malabsorption syndrome, or active ulceration at upper gastrointestinal tract.
- •Coexisting of other malignancies within 5 years, except squamous cell carcinoma and basal cell carcinoma of the skin
- •Participation in any other investigational drug study within 1 month
- •No signed informed consent
研究组 & 干预措施
modified FOLFIRINOX
干预措施: modified FOLFIRINOX regimen (Drug)
结局指标
主要结局
True response rate
时间窗: within 16 weeks
次要结局
- Overall survival(6, 12 months)