Status:
TERMINATED
A Study of Erlotinib (Tarceva) in Participants With Resected Head and Neck Squamous Cell Cancer
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 chemoradioth...
Eligibility Criteria
Inclusion
- 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
- Macroscopic residual disease after surgery
- Previous treatment with anti-epidermal growth factor receptor (anti-EGFR) targeted therapies
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT00412217
Start Date
November 1 2006
End Date
December 1 2009
Last Update
November 25 2016
Active Locations (31)
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1
Alcorcón, Spain, 28922
2
Barcelona, Spain, 08025
3
Barcelona, Spain, 08036
4
Barcelona, Spain, 08907