A Clinical Trial of S-1 Plus Cisplatin Versus 5-FU Plus Cisplatin in Patients With Unresectable or Advanced Gastric Cancer
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 270
- 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 evaluate the effectiveness and safety of s-1 plus cisplatin versus 5-FU plus cisplatin as first-line therapy in the treatment of patients with advanced gastric cancer.
详细描述
This is a randomized, controlled, open-label,multicenter study. Patients are randomized to one of two treatment arms : S-1 plus cisplatin and 5-FU plus cisplatin.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed adenocarcinoma of the stomach with inoperable locally advanced or recurrent and/or metastatic disease.
- •Male or female.
- •Previous chemotherapy for advanced/metastatic disease (prior adjuvant/neoadjuvant therapy is allowed if at least 6 months has elapsed between completion of adjuvant/neoadjuvant therapy and enrolment into the study).
- •Measurable disease, according to the Response Evaluation Criteria in Solid Tumours(RECIST)
- •ECOG Performance status 0, 1 or 2
- •Haematological, Biochemical and Organ Function: Neutrophil count >2.0 × 10 9/L, platelet count > 100 ×10 9/L. Serum bilirubin< 1.5 × upper limit of normal (ULN); or, AST or ALT < 2.5 × ULN (or < 5 × ULN in patients with liver metastases); or, alkaline phosphatase< 2.5 × ULN (or > 5 × ULN in patients with liver metastases,Creatinine clearance > 60 mL/min.
- •Signed informed consent.
排除标准
- •prior adjuvant/neoadjuvant therapy more than two regiments.
- •Received any investigational drug treatment within 30 days of start of study treatment.
- •Patients with active gastrointestinal bleeding.
- •Neurological toxicity ≥ grade 2 NCI-CTCAE.
- •Other malignancy within the last 5 years, except for carcinoma in situ of the cervix, or basal cell carcinoma.
- •History or clinical evidence of brain metastases.
- •Serious uncontrolled systemic intercurrent illness, e.g. infections or poorly controlled diabetes.
- •Pregnancy women.
- •Subjects with reproductive potential not willing to use an effective method of contraception.
- •Patients with known active infection with HIV.
- •Known hypersensitivity to any of the study drugs.
研究组 & 干预措施
S-1 plus cisplatin
S-1:80 mg/m2/day po twice daily on Day 1-21,cisplatin: 20mg/m2 iv on Day 1-4, repeat every 5 weeks.Number of Cycles: until progression or unacceptable toxicity develops.
干预措施: s-1 plus cisplatin (Drug)
5-Fu plus cisplatin
5-Fu 800 mg/m2/d CI 120h ,Cisplatin 20 mg/m2 as a 2 hour i.v. infusion(on day 1 to day 4 )repeat every 4 weeks.Number of Cycles: until progression or unacceptable toxicity develops.
干预措施: 5-Fu plus cisplatin (Drug)
结局指标
主要结局
Time to progression
时间窗: The time from randomization until objective tumor progression or death
次要结局
- Response rate(2 months)