a Phase II Study of Oxaliplatin Plus S-1 (SOX) as First-line Treatment for Patients With Advanced Gastric Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Progression Free Survival
研究概览
简要总结
The purpose of this study is to determine the efficacy and safety of oxaliplatin and s1 as first-line treatment of advanced gastric cancer.
详细描述
There was no evidence of standard chemotherapy for advanced gastric cancer (AGC) in China. Fluoropyrimidines and cisplatin have been widely used in a variety of combinations in the treatment of AGC. Capecitabine/cisplatin combination therapy showed an overall response rate (ORR) of 41- 55%, a median time to progression/progression free survival (TTP/PFS) of 5.6-6.3 months, and a median overall survival (OS) of 10.1-10.5 months. Though no studies have compared two oral fluoropyrimidines in combination with oxaliplatin, both S-1 and capecitabine appear to be comparable in terms of efficacy and safety. The investigators conducted a phase II trial of oxaliplatin combined with S-1 in the treatment of first-line AGC.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proven in operable advanced gastric adenocarcinoma (including adenocarcinoma of the gastrooesophageal junction) or relapse gastric adenocarcinoma
- •Measurable lesion and/or non-measurable lesion defined by RECIST
- •ECOG performance status ≦ 1
- •Hgb ≧ 8g/dL, WBC 4000-12000/mm3, platelets ≧ 100,000/mm3
- •Creatine ≦ upper normal limit (UNL)
- •Total bilirubin ≦ 1.5 X UNL
- •AST, ALT and ALP ≦ 2.5 x UNL
- •Subjects must be able to take orally
- •No prior chemotherapy
- •Life expectancy estimated than 3 months
- •Written informed consent
排除标准
- •Pregnancy or lactation women, or women with suspected pregnancy or men with willing to get pregnant
- •Known brain metastases
- •History of hypersensitivity to fluoropyrimidines, oxaliplatin
- •Active double cancer
- •Treatment with any investigational product during the last 4 weeks prior to study entry
- •Symptomatic peripheral neuropathy ≧ garde
- •by NCI-CTCAE ver.3.0
- •Any previous chemotherapy or radiotherapy for AGC
研究组 & 干预措施
treatment
oxaliplatin+s1
干预措施: Oxaliplatin (Drug)
treatment
oxaliplatin+s1
干预措施: s1 (Drug)
结局指标
主要结局
Progression Free Survival
时间窗: 2 years
from date of treatment was administered until the date of first documented progression or death from any cause whichever first, assessed every 6 weeks
次要结局
- overall survival(2 years)
- number of participants with adverse events(2 years)
- Response Rate(2 years)
研究者
Lin Yang
MD
Chinese Academy of Medical Sciences