An observational study in Carcinoma, Squamous Cell of Head and Neck, sponsored by Merck KGaA, Darmstadt, Germany. Completed at 1 site in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-07-08.
Sponsored by Merck KGaA, Darmstadt, Germany · Observational
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.
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:
Secondary objectives:
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 215 is above the median of 149 across 1,175 observational studies indexed under Carcinoma.
Browse Carcinoma studies →Merck KGaA, Darmstadt, Germany is the lead sponsor of 269 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Subjects with SCCHN and are eligible to receive cetuximab and radiotherapy according to the local label
Exclusion Criteria:
Other: No Intervention
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).
Also known as: Erbitux®
Number of adverse drug reactions and serious adverse drug reactions
Time frame: 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
Time frame: From the first infusion of cetuximab 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
Time frame: From the first infusion of cetuximab until three months after the last infusion of cetuximab
Time to progression
Time frame: From the first infusion of cetuximab until three months after the last infusion of cetuximab
Duration of response
Time frame: From the first infusion of cetuximab until three months after the last infusion of cetuximab
Overall Survival
Time frame: From the first infusion of cetuximab to death until three months after the last infusion of cetuximab
This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
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Merck KGaA, Darmstadt, Germany