NCT01090505Unknown2 期
Phase 2 Study of S-1 and Oxaliplatin as Neoadjuvant Chemotherapy for Locally Advanced
Chinese PLA General Hospital1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2009年11月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- overall survival
研究概览
简要总结
The purpose of this study is to determine whether S-1 and oxaliplatin as neoadjuvant chemotherapy may improve survival benefit compared with control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed gastric adenocarcinoma Locally advanced disease:Clinical stage T3-4, N0-3, M0 (according to the Japanese gastric cancer classification)
- •Planning to undergo gastric cancer D2 surgery after neoadjuvant chemotherapy
- •Age:20 to 75
- •Performance status:ECOG 0-2
- •Life expectancy:Not specified
- •Hematopoietic:WBC 4,000-12,000/mm^3；Granulocyte count ≥ 2,000/mm^3；Platelet count ≥ 100,000/mm^3；Hemoglobin ≥ 9.0 g/dL;Hepatic:AST and ALT ≤ 100 U/L；Bilirubin ≤ 1.5 mg/dL
- •Adequate organ function
- •Able to swallow oral medication
- •Written informed consent
排除标准
- •Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ
- •Pregnant or breast-feeding women
- •Severe mental disease
- •Systemic administration of corticosteroids, flucytosine, phenytoin or warfarin
- •Other severe complications such as paralytic ileus, intestinal pneumonitis, pulmonary fibrosis, or ischemic heart disease
- •Myocardial infarction within six disease-free months
结局指标
主要结局
overall survival
时间窗: 5 years
次要结局
- response rate(3 months)
研究者
研究点 (1)
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