A Study of Erlotinib (Tarceva) in Participants With Resected Head and Neck Squamous Cell Cancer
11 oktober 2016 bijgewerkt door: Hoffmann-La Roche
Phase III Randomized, Controlled Trial of Erlotinib (Tarceva) as Maintenance Therapy in Patients With Squamous Cell Carcinoma of the Head and Neck Treated With Resection and Radiotherapy With or Without Concomitant Chemotherapy With Curative Aim
This two-arm study will compare the efficacy and safety of erlotinib (Tarceva) versus placebo in participants with resected head and neck squamous cell cancer who are receiving concurrent chemoradiotherapy or radiotherapy alone.
Participants will be randomized to receive either erlotinib 150 milligrams (mg) orally (PO) once daily or placebo for 1 year until disease progression or unacceptable toxicity.
Studie Overzicht
Toestand
Beëindigd
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
94
Fase
- Fase 3
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Alcorcon, Spanje, 28922
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Barcelona, Spanje, 08036
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Barcelona, Spanje, 08907
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Barcelona, Spanje, 08025
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Barcelona, Spanje, 08916
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Burgos, Spanje, 09005
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Cordoba, Spanje, 14004
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Granada, Spanje, 18014
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Guadalajara, Spanje, 19002
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Jaen, Spanje, 23007
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Lugo, Spanje, 27004
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Madrid, Spanje, 28006
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Madrid, Spanje, 28040
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Madrid, Spanje, 28041
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Madrid, Spanje, 28007
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Madrid, Spanje, 28033
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Murcia, Spanje, 30008
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Orense, Spanje, 32005
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Palma de Mallorca, Spanje, 07014
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Salamanca, Spanje, 37007
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San Sebastian, Spanje, 20012
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San Sebastian, Spanje, 20080
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Santander, Spanje, 39008
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Sevilla, Spanje, 41013
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Sevilla, Spanje, 41009
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Toledo, Spanje, 45004
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Valencia, Spanje, 46026
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Valencia, Spanje, 41014
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Valencia, Spanje, 46015
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Zamora, Spanje, 49021
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Zaragoza, Spanje, 50009
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- Adults greater than or equal to (≥) 18 years of age
- Curatively treated head and neck squamous cell cancer with T3-T4 and/or N2-N3 pathology, with or without other findings of poor prognosis such as extranodal extension, positive resection margins, and perineural or vascular involvement
- Eastern Cooperative Oncology Group (ECOG) status of 0 to 2
Exclusion Criteria:
- Macroscopic residual disease after surgery
- Previous treatment with anti-epidermal growth factor receptor (anti-EGFR) targeted therapies
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Erlotinib
Participants treated with surgical resection and chemoradiotherapy or radiotherapy alone will receive erlotinib tablets as 150 mg PO daily for 1 year until disease progression or intolerable toxicity.
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Erlotinib will be given as 150 mg PO once daily.
Andere namen:
Additional clinical management including surgical resection and chemoradiotherapy or radiotherapy alone will be at the discretion of the Investigator according to local standard of care.
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Placebo-vergelijker: Placebo
Participants treated with surgical resection and chemoradiotherapy or radiotherapy alone will receive placebo treatment for 1 year until disease progression or intolerable toxicity.
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Additional clinical management including surgical resection and chemoradiotherapy or radiotherapy alone will be at the discretion of the Investigator according to local standard of care.
Participants will receive placebo tablets (matched to erlotinib) once daily.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Number of Participants With Disease Progression
Tijdsspanne: From inclusion in the study until disease progression (maximum up to 3 years overall)
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Tumor response was assessed by the Investigator according to standard-of-care criteria, as there were no protocol-specified criteria for the assessment of tumor response and the instrument for assessment was deferred to the Investigator.
To ensure comparability, baseline radiological studies later used to verify progression must be performed using identical techniques.
The number of participants who experienced disease progression was reported.
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From inclusion in the study until disease progression (maximum up to 3 years overall)
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Time to Progression (TTP)
Tijdsspanne: From inclusion in the study until disease progression, appearance of second tumor, or death from any cause (maximum up to 3 years overall)
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Tumor response was assessed by the Investigator according to standard-of-care criteria, as there were no protocol-specified criteria for the assessment of tumor response and the instrument for assessment was deferred to the Investigator.
TTP was defined as the time from inclusion in the study to the time of disease progression, appearance of second tumor, or death from any cause, whichever occurred first.
To ensure comparability, baseline radiological studies later used to verify progression must be performed using identical techniques.
The median duration of TTP and corresponding 95% confidence interval (CI) were to be estimated by Kaplan-Meier analysis and expressed in months.
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From inclusion in the study until disease progression, appearance of second tumor, or death from any cause (maximum up to 3 years overall)
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Number of Participants Who Died
Tijdsspanne: From inclusion in the study until death from any cause (maximum up to 3 years overall)
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The number of participants who died from any cause was reported.
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From inclusion in the study until death from any cause (maximum up to 3 years overall)
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Overall Survival (OS)
Tijdsspanne: From inclusion in the study until death from any cause (maximum up to 3 years overall)
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OS was defined as the time from inclusion in the study to date of death for any reason.
The median duration of OS and corresponding 95% CI were to be estimated by Kaplan-Meier analysis and expressed in months.
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From inclusion in the study until death from any cause (maximum up to 3 years overall)
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 november 2006
Primaire voltooiing (Werkelijk)
1 december 2009
Studie voltooiing (Werkelijk)
1 december 2009
Studieregistratiedata
Eerst ingediend
15 december 2006
Eerst ingediend dat voldeed aan de QC-criteria
15 december 2006
Eerst geplaatst (Schatting)
18 december 2006
Updates van studierecords
Laatste update geplaatst (Schatting)
25 november 2016
Laatste update ingediend die voldeed aan QC-criteria
11 oktober 2016
Laatst geverifieerd
1 oktober 2016
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- ML20294
- 2006-001845-33 (EudraCT-nummer)
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 .