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- Klinische proef NCT01075828
Prospective, Post Marketing Surveillance Study On Erbitux® (Cetuximab) in Patients With Locally Advanced or Recurrent and/or Metastatic Squamous Cell Cancer of the Head and Neck in Korea
A Korean Post Marketing Surveillance Study On Erbitux® (Cetuximab) In Patients With Locally Advanced or Recurrent and/or Metastatic Squamous Cell Cancer of the Head and Neck (SCCHN)
After consultation with the Korean Health Authorities, the two Post-Authorization Safety Studies EMR 62202-509 (NCT01082315) and EMR 62241-508 (NCT01075828) were combined within one study protocol EMR 062202-551. This Post-Marketing Surveillance Study (PMS) EMR 062202-551 is requested by the Korean Health Authorities to continue monitoring of Erbitux and provide further information about safety and toxicity in clinical practice in at least 900 patients during 6 years.
All data points from the EMR 62202-509 (NCT01082315) and EMR 62241-508 (NCT01075828) remain unchanged in protocol EMR 062202-551. Therefore, the Sponsor has decided not to separately disclose the EMR 062202-551 study titled "A Korean Post-Marketing Surveillance Study On Erbitux® (Cetuximab) in Patients With Locally Advanced or Recurrent and/or Metastatic Squamous Cell Cancer of the Head and Neck (originally EMR 62241-508) and in Patients With EGFR-expressing, KRAS wild-type Metastatic Colorectal Cancer (originally EMR 62202-509)" on clinicaltrials.gov.
Studie Overzicht
Gedetailleerde beschrijving
This is a prospective, Post Marketing Surveillance (PMS) study on Erbitux® (Cetuximab) in patients with locally advanced or recurrent and/or metastatic squamous cell cancer of the head and neck in Korea
This prospective study will collect safety information from more than 300 subjects treated with Erbitux as final evaluable cases. During the PMS period, subject background, subject's medical (surgery, anti-cancer treatment) history, Erbitux treatment status, concurrent medication, response evaluation, status and reason of discontinuation, all adverse events (AEs; regardless of the causal relationship to Erbitux), and abnormal results of laboratory tests will be collected for the study purpose.
The PMS is based on all cases treated with Erbitux at least once. The PMS will be done within 6 years from the approval date of the new indication. This PMS is requested by the Korean Regulatory Authorities. After approval of new indication in Korea, it is further required to investigate more than 300 subjects during 6 years according to local regulations to continue monitoring and provide further information about safety and toxicity in clinical practice.
OBJECTIVES Analysis on safety and efficacy information on the use of Erbitux in the market and factors affecting its safety and efficacy.
Primary objective:
- To obtain safety information on the use of Erbitux in subjects with locally advanced SCCHN or recurrent and/or metastatic in terms of frequency and severity of AEs
Secondary objectives:
- To gather clinical efficacy information of the treatment
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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Jung-gu Daejeon, Korea, republiek van, 301-721
- Chungnam national university hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria:
- Subjects who are eligible for Erbitux treatment according to the indication in the national label of Erbitux. The national label approved by Korea Food & Drug Administration is "Erbitux in combination with radiation therapy is indicated for the treatment of subjects with locally advanced or recurrent and/or metastatic SCCHN
Exclusion Criteria:
- Subjects who are not eligible for Erbitux treatment according to the indication in the national label of Erbitux
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Frequency of Adverse Events
Tijdsspanne: 6 years
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The frequency and severity of all adverse events, regardless of the causal relationship to Erbitux, will be measured within 6 years of the observational period from the approval date of the new indication
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6 years
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Clinical efficacy
Tijdsspanne: 6 years
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The duration of control of locoregional disease, 1-year/2-year/3-year locoregional control rate, best tumor response will be measured within the observational period from the approval date of the new indication
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6 years
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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- EMR62241-508 (EMR 62202-551)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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