A Study of Erlotinib (Tarceva) in Participants With Resected Head and Neck Squamous Cell Cancer
NCT ID: NCT00412217
Last Updated: 2016-11-25
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
PHASE3
94 participants
INTERVENTIONAL
2006-11-30
2009-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Erlotinib
Erlotinib will be given as 150 mg PO once daily.
Standard of care
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.
Placebo
Participants treated with surgical resection and chemoradiotherapy or radiotherapy alone will receive placebo treatment for 1 year until disease progression or intolerable toxicity.
Placebo
Participants will receive placebo tablets (matched to erlotinib) once daily.
Standard of care
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.
Interventions
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Placebo
Participants will receive placebo tablets (matched to erlotinib) once daily.
Erlotinib
Erlotinib will be given as 150 mg PO once daily.
Standard of care
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Previous treatment with anti-epidermal growth factor receptor (anti-EGFR) targeted therapies
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Alcorcón, , Spain
Barcelona, , Spain
Barcelona, , Spain
Barcelona, , Spain
Barcelona, , Spain
Burgos, , Spain
Córdoba, , Spain
Donostia / San Sebastian, , Spain
Donostia / San Sebastian, , Spain
Granada, , Spain
Guadalajara, , Spain
Jaén, , Spain
Lugo, , Spain
Madrid, , Spain
Madrid, , Spain
Madrid, , Spain
Madrid, , Spain
Madrid, , Spain
Murcia, , Spain
Ourense, , Spain
Palma de Mallorca, , Spain
Salamanca, , Spain
Santander, , Spain
Seville, , Spain
Seville, , Spain
Toledo, , Spain
Valencia, , Spain
Valencia, , Spain
Valencia, , Spain
Zamora, , Spain
Zaragoza, , Spain
Countries
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Other Identifiers
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2006-001845-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ML20294
Identifier Type: -
Identifier Source: org_study_id