A Post Marketing Surveillance Study of Cetuximab in Patients With Squamous Cell Carcinoma of Head and Neck (SCCHN)
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
Tainan County
-
Liouying, Tainan County, Taiwan
- Liouying Chi-Mei Hospital
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
Icke-interventionsstudie
|
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).
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Number of adverse drug reactions and serious adverse drug reactions
Tidsram: 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
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Number of subjects with best tumor response categories that are, complete response, partial response, stable disease, progressive disease and not evaluable
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Chao-Jung Tsao, Dr., Liouying Chi-Mei Hospital
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- EMR62202-512
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