A Post Marketing Surveillance Study of Cetuximab in Patients With Squamous Cell Carcinoma of Head and Neck (SCCHN)
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Tainan County
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Liouying, Tainan County, Taïwan
- Liouying Chi-Mei Hospital
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
Étude non interventionnelle
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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).
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Number of adverse drug reactions and serious adverse drug reactions
Délai: 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
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Number of subjects with best tumor response categories that are, complete response, partial response, stable disease, progressive disease and not evaluable
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Chao-Jung Tsao, Dr., Liouying Chi-Mei Hospital
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- EMR62202-512
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