A Randomized Phase II Study of mFOLFOX vs. mFOLFIRI in Advanced or Recurrent Biliary Tract Cancer Refractory to First Line Gemcitabine Plus Cisplatin
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- 6 months overall survival rate
研究概览
简要总结
In second line with advanced or recurrent biliary tract cancer refractory to first line gemcitabine plus cisplatin, efficacy of mFOLFOX vs. mFOLFIRI will be evaluated at randomized phase 2 trial.
详细描述
- brief enrollment criteria
- histological confirmed
- refractory to first line gemcitabine plus cisplatin
- fit for chemotherapy
- treatment arms A. mFOLFOX D1 oxaliplatin 100mg/m2 over 2hr Leucovorin 100mg/m2 over 2hr 5FU 2400mg/m2 over 46hr Every 2 weeks
B. mFOLFIRI D1 Irinotecan 150mg/m2 over 2hr Leucovorin 100mg/m2 over 2hr 5FU 2400mg/m2 over 46hr Every 2 weeks 3. randomization - stratified by tumor site and performance status
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •20 years and older
- •pathologically confirmed biliary tract cancer (adenocarcinoma) including intrahepatic, extrahepatic, gallbladder, ampulla of vater
- •initially inoperable or recurrent
- •as first line chemotherapy, refractory to gemcitabine/cisplatin (at least one cycle applied)
- •evaluable or measurable lesion
- •within 1 week, patients who meet below laboratory results (hemoglobin >9.0 g/dL, neutrophil >1000/uL, platelet> 75000/uL, serum creatinine < UNL * 1.5, AST/ALT < UNL*3, total bilirubin < UNL*1.5 (available for biliary drainage)
- •patients who have ability to understand the purpose, benefit and harm for this trial, and the right to withdraw this trial in any time without any disadvantage
排除标准
- •other cancer history
- •pregnant or lactating
- •uncontrolled medical condition such as infection or cardiovascular disease
- •hypersensitivity to experimental drugs
- •uncontrolled CNS metastasis, psychologic problem
研究组 & 干预措施
mFOLFOX
D1 oxaliplatin 100mg/m2 over 2hr Leucovorin 100mg/m2 over 2hr 5FU 2400mg/m2 over 46hr Every 2 weeks
干预措施: Oxaliplatin,5FU, leucovorin (Drug)
mFOLFIRI
D1 Irinotecan 150mg/m2 over 2hr Leucovorin 100mg/m2 over 2hr 5FU 2400mg/m2 over 46hr Every 2 weeks
干预措施: irinotecan,5FU, leucovorin (Drug)
结局指标
主要结局
6 months overall survival rate
时间窗: 6months
at 6 months from intervention treatment, overall survival rate
次要结局
- response rate(6months)
- Number of Participants With Treatment-Related Adverse Events as Assessed by NCI CTC version 4.0(6months)
- disease control rate(6months)
- progression free survival(6months)
研究者
Jin Won Kim
Clinical Associate Professor
Seoul National University Bundang Hospital