Randomized Phase II Trial of Gemcitabine/Cisplatin Versus S-1/Cisplatin in Advanced Biliary Cancer Patients
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Time to progression
研究概览
简要总结
The purpose of this study is to compare the efficacy between gemcitabine/cisplatin and S-1/cisplatin in the first-line treatment in advanced biliary tract cancer.
详细描述
Standard chemotherapy regimen for biliary tract cancer(BTC) has not been established due to the difficulty associated with performing clinical trials in this field.
Gemcitabine or fluoropyrimidines, including 5-fluorouracil and S-1, are routinely used for BTC chemotherapy. The European Society for Medical Oncology (ESMO) and the National Comprehensive Cancer Network guidelines published in 2009 recommend either gemcitabine-based or fluoropyrimidine-based chemotherapy or clinical trials for first-line treatment.
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
- •Age : older than 20
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 -2
- •Histologically confirmed adenocarcinoma of the biliary tract
- •Metastatic or unresectable biliary cancer
- •No prior chemotherapy for biliary cancer
- •A patient with at least one measurable primary lesion of which the diameter is confirmed to be 10mm in Spiral CT or multidetector CT (MD CT)
- •Adequate bone marrow, liver, renal function
排除标准
- •A patient with no measurable disease
- •A patient who received previous palliative chemotherapy for biliary cancer
- •A patient who received adjuvant chemotherapy for biliary cancer within 1year
- •A patient with previous active or passive immunotherapy.
- •A pregnant or lactating patient
研究组 & 干预措施
Gemcitabine/Cisplatin
干预措施: Gemcitabine, Cisplatin (Drug)
S-1/Cisplatin
D1-14 S-1 40mg/m2 po bid D1,D8 Cisplatin 25/m2 + N/S 150cc miv over 60mins Repeated every 3 weeks
干预措施: S-1, Cisplatin (Drug)
结局指标
主要结局
Time to progression
时间窗: From the assigned day to the disease progression or the last day of follow-up without progression. Clinically assessment would be done every cycle (month) and radiologically assessed every 6 weeks with CT scan
次要结局
- Response rate Overall survival Safety profile(Overall survival is measured from the first day of assignment until death or the last day of the follow-up.Clinically assessment would be done every cycle (month) and radiologically assessed every 2 cycles (6 weeks) with CT scan)