A Korean Post-Marketing Surveillance Study On Erbitux (Cetuximab) In Patients With Recurrent And/Or Metastatic Squamous Cell Carcinoma Of The Head And Neck
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Safety
研究概览
简要总结
This is a prospective post-marketing surveillance (PMS) study to collect safety information from more than 600 subjects with recurrent and/or metastatic squamous cell cancer of the head and neck (SCCHN) treated with Erbitux as final evaluable cases. This PMS study is requested by the Korean Regulatory Authorities. After approval of new indication in Korea, there is a requirement to investigate more than 600 subjects during six years, to continue monitoring and provide further information about safety and toxicity in clinical practice.
详细描述
The PMS study is planned to be conducted within 6 years from the approval date of the new indication in approximately 50 institutions in Korea.
OBJECTIVES
Primary objective:
- To obtain safety information on the use of Erbitux in subjects with recurrent and/or metastatic SCCHN in terms of frequency and severity of adverse events (AEs)
Secondary objectives:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who are eligible for Erbitux treatment according to the indication in the national label of Erbitux. The national label approved by Korea Food & Drug Administration is "Erbitux in combination with radiation therapy is indicated for the treatment of subjects with metastatic/recurrent SCCHN.
排除标准
- 未提供
结局指标
主要结局
Safety
时间窗: After approval of new indication till 6 years of PMS period
Frequency and severity of all adverse events (AEs), regardless of the causal relationship to Erbitux
次要结局
- Efficacy(Throughout 6 years of PMS period)