A Post Marketing Surveillance Study of Cetuximab in Patients With Squamous Cell Carcinoma of Head and Neck (SCCHN)
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
Tainan County
-
Liouying, Tainan County, Taiwan
- Liouying Chi-Mei Hospital
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Ikke-intervensjonell studie
|
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).
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Number of adverse drug reactions and serious adverse drug reactions
Tidsramme: From the first infusion of cetuximab until three months after the last infusion of Cetuximab
|
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
Tidsramme: From the first infusion of cetuximab until three months after the last infusion of Cetuximab
|
From the first infusion of cetuximab until three months after the last infusion of Cetuximab
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Number of subjects with best tumor response categories that are, complete response, partial response, stable disease, progressive disease and not evaluable
Tidsramme: From the first infusion of cetuximab until three months after the last infusion of cetuximab
|
From the first infusion of cetuximab until three months after the last infusion of cetuximab
|
|
Time to progression
Tidsramme: From the first infusion of cetuximab until three months after the last infusion of cetuximab
|
From the first infusion of cetuximab until three months after the last infusion of cetuximab
|
|
Duration of response
Tidsramme: From the first infusion of cetuximab until three months after the last infusion of cetuximab
|
From the first infusion of cetuximab until three months after the last infusion of cetuximab
|
|
Overall Survival
Tidsramme: From the first infusion of cetuximab to death until three months after the last infusion of cetuximab
|
From the first infusion of cetuximab to death until three months after the last infusion of cetuximab
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Chao-Jung Tsao, Dr., Liouying Chi-Mei Hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- EMR62202-512
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