A Post Marketing Surveillance Study of Cetuximab in Patients With Squamous Cell Carcinoma of Head and Neck (SCCHN)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 215
- 试验地点
- 1
- 主要终点
- Number of adverse drug reactions and serious adverse drug reactions
研究概览
简要总结
This is a prospective, observational, non-interventional, multicenter, post-marketing surveillance study to mainly collect safety information from subjects with locally advanced and recurrent/metastatic Squamous Cell Carcinoma of Head and Neck (SCCHN) treated with cetuximab based on the locally approved label.
详细描述
Cetuximab is an immunoglobulin G1 (IgG1) monoclonal antibody that enhances the effects of some common chemotherapy agents and radiotherapy and demonstrates minimal overlapping toxicities with these approaches. This prospective, observational, non-interventional and multi-centric post marketing surveillance study is being conducted to collect safety information from subjects with locally advanced or recurrent/metastatic SCCHN treated with cetuximab based on the locally approved label. Study plans to enroll 200 to 300 subjects, who are eligible for cetuximab treatment according to the indication in the approved label of cetuximab by Taiwan Health Authority. Data related to subjects' demographics, relevant tumor history, and laboratory information (hematology, biochemistry) will be captured and analyzed descriptively.
OBJECTIVES
Primary objective:
• To obtain safety information on the use of cetuximab in subjects with SCCHN according to the regulatory approved label and in a regular clinical setting
Secondary objectives:
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 proven Stage 3-4 locally advanced SCCHN (oropharynx, hypopharynx, larynx) or recurrent and/or metastatic SCCHN
- •Age greater than or equal to 18 years
- •Signed informed consent
排除标准
- •Subjects with known severe (Grade 3 or 4; National Cancer Institute Common Toxicity Criteria Version 4.03) hypersensitivity reactions to Cetuximab
- •Subjects with contraindications for concomitantly used chemotherapeutic agents or radiation therapy, identified before initiation of cetuximab combination treatment
结局指标
主要结局
Number of adverse drug reactions and serious adverse drug reactions
时间窗: From the first infusion of cetuximab until three months after the last infusion of Cetuximab
Number of subjects discontinuing the study due to intolerability of cetuximab
时间窗: From the first infusion of cetuximab until three months after the last infusion of Cetuximab
次要结局
- Duration of response(From the first infusion of cetuximab until three months after the last infusion of cetuximab)
- Overall Survival(From the first infusion of cetuximab to death until three months after the last infusion of cetuximab)
- Number of subjects with best tumor response categories that are, complete response, partial response, stable disease, progressive disease and not evaluable(From the first infusion of cetuximab until three months after the last infusion of cetuximab)
- Time to progression(From the first infusion of cetuximab until three months after the last infusion of cetuximab)