NCT01220934已完成不适用
Clinical Practice Surveillance of the Use of Herceptin in Patients With HER2-positive Advanced Adenocarcinoma of the Stomach or Gastro-esophageal Junction (GEJ) (HERMES)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 443
- 试验地点
- 1
- 主要终点
- Response rate according to Response Evaluation Criteria in Solid Tumors (RECIST)
研究概览
简要总结
This observational, multicenter study will assess the efficacy and safety of Herceptin (trastuzumab) in routine clinical practice in patients with HER2-positive advanced adenocarcinoma of the stomach or gastro-esophageal junction. Data from patients will be collected for approximately 12 months.
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
- •Adult patients, >/=18 years of age
- •Histologically confirmed advanced adenocarcinoma of the stomach or gastro-esophageal junction (GEJ) with locally advanced and/or metastatic disease
- •HER2-positive tumor
- •Patients who are eligible for treatment with Herceptin according to the judgment of the physician
排除标准
- •Unwilling or unable to sign informed consent form
- •Any contraindications, interactions and incompatibilities to Herceptin
结局指标
主要结局
Response rate according to Response Evaluation Criteria in Solid Tumors (RECIST)
时间窗: 12 months
Progression-free survival according to Response Evaluation Criteria in Solid Tumors (RECIST)
时间窗: 12 months
Overall survival according to Response Evaluation Criteria in Solid Tumors (RECIST)
时间窗: 12 months
次要结局
- Documentation of the testing process for HER2-positive tumors(12 months)
- Assessment of implementation of guidelines and recommendations of Herceptin administration in routine clinical practice(12 months)
- Documentation of backbone chemotherapy treatment and concomitant medication(12 months)
- Quality of Life questionnaire(12 months)
- Surveillance of weight change(12 months)
- Safety (incidence of adverse events)(12 months)
- Surveillance of pain intensity and analgesic consumption(12 months)
研究者
研究点 (1)
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