NCT03211377Unknown不适用
Non-interventional Study to Evaluate Chemotherapy for Potentially Resectable Locally Advanced Esophagogastric Junction Carcinoma
Anyang Tumor Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2017年3月29日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- disease free survival(DFS)
研究概览
简要总结
This is a non-interventional study to observe the safety and efficiency of chemotherapy for potentially resectable locally advanced esophagogastric junction
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 or cytological proved locally advanced esophagogastric junction cancer
- •ECOG performance status ≦2
- •Stage IIa-IIIc
- •No distant metastasis (M0)
- •Sign in Informed Consent Form
排除标准
- •History of hypersensitivity to fluoropyrimidines, Tegafur，Gimeracil and Oteracil Potassium Capsules , capecitabine, oxaliplatin or the ingredients of this product
- •Pregnancy or lactation women,
- •Inadequate hematopoietic function： WBC≦3,500/mm3; ANC≦1,500/mm3; Platelet≦80,000/mm3
- •Inadequate organ function which is defined as below:
- •Total bilirubin >2 pper limit of normal range (ULN); ALT / AST > 2.5 upper limit of normal range (ULN); serum creatinine > 1.5 mg/dL, and Ccr > 60 ml/min (estimated by Cockcroft-Gault formulation);
- •Symptomatic peripheral neuropathy
- •Receiving a concomitant treatment with other fluoropyrimidines
- •Fluoropyrimidines (DPD) congenital absence
结局指标
主要结局
disease free survival(DFS)
时间窗: up to 3 years
time from surgery to disease recurrence or death
次要结局
- Adverse events(AE)(through study completion, up to 1 year)
- Overall survival (OS)(up to 5 years)
研究者
研究点 (1)
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