A Study of Erlotinib (Tarceva) in Participants With Resected Head and Neck Squamous Cell Cancer
11. oktober 2016 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
94
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Alcorcon, Spanien, 28922
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Barcelona, Spanien, 08036
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Barcelona, Spanien, 08907
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Barcelona, Spanien, 08025
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Barcelona, Spanien, 08916
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Burgos, Spanien, 09005
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Cordoba, Spanien, 14004
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Granada, Spanien, 18014
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Guadalajara, Spanien, 19002
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Jaen, Spanien, 23007
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Lugo, Spanien, 27004
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Madrid, Spanien, 28006
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Madrid, Spanien, 28040
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Madrid, Spanien, 28041
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Madrid, Spanien, 28007
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Madrid, Spanien, 28033
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Murcia, Spanien, 30008
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Orense, Spanien, 32005
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Palma de Mallorca, Spanien, 07014
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Salamanca, Spanien, 37007
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San Sebastian, Spanien, 20012
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San Sebastian, Spanien, 20080
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Santander, Spanien, 39008
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Sevilla, Spanien, 41013
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Sevilla, Spanien, 41009
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Toledo, Spanien, 45004
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Valencia, Spanien, 46026
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Valencia, Spanien, 41014
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Valencia, Spanien, 46015
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Zamora, Spanien, 49021
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Zaragoza, Spanien, 50009
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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.
Andre navne:
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 komparator: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Number of Participants With Disease Progression
Tidsramme: 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)
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Number of Participants Who Died
Tidsramme: 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)
Tidsramme: 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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. november 2006
Primær færdiggørelse (Faktiske)
1. december 2009
Studieafslutning (Faktiske)
1. december 2009
Datoer for studieregistrering
Først indsendt
15. december 2006
Først indsendt, der opfyldte QC-kriterier
15. december 2006
Først opslået (Skøn)
18. december 2006
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
25. november 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
11. oktober 2016
Sidst verificeret
1. oktober 2016
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ML20294
- 2006-001845-33 (EudraCT nummer)
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