NCT03485196已完成不适用
The Relationship Between Microsatellite Instability and Efficacy of Fluorouracil Based Adjuvant Chemotherapy in Gastric Cancer After Operation
Affiliated Hospital of Qinghai University3 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2017年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,000
- 试验地点
- 3
- 主要终点
- Disease Free Survival
研究概览
简要总结
The relationship between Microsatellite instability and efficacy of fluorouracil based adjuvant chemotherapy in gastric cancer after operation.
详细描述
To explore the relationship between Microsatellite instability and efficacy of fluorouracil based adjuvant chemotherapy in gastric cancer after operation.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histopathology or cytopathology proven gastric cancer;
- •Operable advanced gastric cancer patients: primary lesions can be completely excision, no distant metastasis;
- •Postoperative patients who can tolerate 5-FU based (5-FU，S-1 or Capecitabine) adjuvant chemotherapy;
- •Life expectancy of at least 6 months;
- •ECOG（Eastern Cooperative Oncology Group ） score 0-1;
- •Age: 18~80 years old;
- •Normal hemodynamic indices before the recruitment (including blood cell count and liver/kidney function).
- •For example: WBC（White blood cell count ）>4.0×109/L; NEU（Neutrophils）>1.5×109/L; PLT（Platelet）>100×109/L;
- •Roughly normal cardiopulmonary function: No coronary heart disease, myocardial infarction, pulmonary heart disease, refractory hypertension;
- •Not concomitant with other uncontrollable benign diseases before the recruitment;
- •Voluntarily signed the informed consent.
排除标准
- •Advanced gastric cancer patients with distant metastasis and inoperable ;
- •Patients who cannot tolerate 5-FU based adjuvant chemotherapy;
- •Pregnant or lactating women;
- •Patients who have no desire to participate in the study.
结局指标
主要结局
Disease Free Survival
时间窗: 5 years
The time from the primary operation to disease recurrence or death.
次要结局
- Overall survival(OS)(5 years)
研究者
Jiuda Zhao
Professor
Affiliated Hospital of Qinghai University
研究点 (3)
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