NCT01206218Unknown2 期
Evaluation of Customized Treatment According to BRCA1 Assessment in Patients With Advanced Gastric Cancer
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School0 个研究点目标入组 96 人开始时间: 2010年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 96
- 主要终点
- Progression-free Survival
研究概览
简要总结
Evaluation of customized treatment according to BRCA1 assessment in patients with advanced gastric cancer
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of informed consent
- •Female or male aged 18 years and over
- •Histologic or cytologic confirmation of advanced gastric cancer
- •Stage III-IV (AJCC 7th)
- •ECOG: 0-2
- •Have tumor sample that can be tested for BRCA1 mRNA expression
- •Negative pregnancy test for women of childbearing potential
- •Neutrophile granulocyte greater than 1.5×10^9/L
- •Hemoglobin greater than 10g/dL
- •Platelet greater than 100×10^9/L
- •Serum bilirubin not greater than 1.5x upper limit of reference range (ULRR)
- •ALT or AST not greater than 1.5x ULRR
- •Creatinine clearance no less than 60ml/min
排除标准
- •Have at least another primary malignant tumor
- •Active infection
- •Chemotherapy with experimental drug within 3 weeks before the start of study therapy
- •Women who are pregnant or breast feeding
- •Weight loss greater 10% within 6 weeks before the start of study therapy
研究组 & 干预措施
Group A
Active Comparator
FLOT Regimen
干预措施: FLOT Regimen (Drug)
Group B
Experimental
FLO Regimen or FLOT Regimen
干预措施: FLO Regimen or FLOT Regimen (Drug)
结局指标
主要结局
Progression-free Survival
时间窗: 12 months
次要结局
- Response Rate(12 months)
- Overall Survival(12 months)
研究者
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