A Post Marketing Surveillance Study of Cetuximab in Patients With Squamous Cell Carcinoma of Head and Neck (SCCHN)
研究概览
详细说明
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:
• To gather clinical efficacy information of the treatment
研究类型
注册 (实际的)
联系人和位置
学习地点
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Tainan County
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Liouying、Tainan County、台湾
- Liouying Chi-Mei Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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非干预研究
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Subjects administered with Cetuximab, once weekly by intravenous infusion at a first dose of 400 milligram per square meter (mg/m^2) body surface area for 120 minutes infusion period and subsequently at a dose of 250 mg/m^2 for 60 minutes infusion period, will be observed.
The maximum infusion rate must not exceed 10 milligram per minute (mg/min).
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Number of adverse drug reactions and serious adverse drug reactions
大体时间：From the first infusion of cetuximab until three months after the last infusion of Cetuximab
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From the first infusion of cetuximab until three months after the last infusion of Cetuximab
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Number of subjects discontinuing the study due to intolerability of cetuximab
大体时间：From the first infusion of cetuximab until three months after the last infusion of Cetuximab
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From the first infusion of cetuximab until three months after the last infusion of Cetuximab
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Number of subjects with best tumor response categories that are, complete response, partial response, stable disease, progressive disease and not evaluable
大体时间：From the first infusion of cetuximab until three months after the last infusion of cetuximab
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From the first infusion of cetuximab until three months after the last infusion of cetuximab
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Time to progression
大体时间：From the first infusion of cetuximab until three months after the last infusion of cetuximab
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From the first infusion of cetuximab until three months after the last infusion of cetuximab
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Duration of response
大体时间：From the first infusion of cetuximab until three months after the last infusion of cetuximab
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From the first infusion of cetuximab until three months after the last infusion of cetuximab
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Overall Survival
大体时间：From the first infusion of cetuximab to death until three months after the last infusion of cetuximab
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From the first infusion of cetuximab to death until three months after the last infusion of cetuximab
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合作者和调查者
调查人员
- 首席研究员：Chao-Jung Tsao, Dr.、Liouying Chi-Mei Hospital
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.