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Prospective, observational, multicentre post-marketing surveillance study to mainly collect safety information from subjects with locally advanced HNSCC treated with Erbitux in combination with radiotherapy based on the locally approved label.
Erbitux 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 HNSCC treated with Erbitux based on the locally approved label. Study plans to enroll 150-200 subjects, who are eligible for Erbitux treatment according to the indication in the approved label of Erbitux by Taiwan Health Authority. Data related to subjects' demographics, relevant tumour history, and laboratory information (hematology, biochemistry) will be captured and analysed descriptively.
- To obtain safety information on the use of Erbitux combined with radiotherapy in subjects with locally advanced HNSCC
- To gather clinical efficacy information of the treatment
Observational Model: Cohort, Time Perspective: Prospective
Head and Neck Squamous Cell Carcinoma
Liouying Chi-Mei Hospital
Not yet recruiting
Published on BioPortfolio: 2014-08-27T03:15:29-0400
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Unusual tumor affecting any site of the body, but most often encountered in the head and neck. Considerable debate has surrounded the histogenesis of this neoplasm; however, it is considered to be a myoblastoma of, usually, a benign nature. It affects women more often than men. When it develops beneath the epidermis or mucous membrane, it can lead to proliferation of the squamous cells and mimic squamous cell carcinoma.
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A carcinoma derived from stratified squamous epithelium. It may also occur in sites where glandular or columnar epithelium is normally present. (From Stedman, 25th ed)
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