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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Page 1 of 8 (31 locations)

1

Alcorcón, Spain, 28922

2

Barcelona, Spain, 08025

3

Barcelona, Spain, 08036

4

Barcelona, Spain, 08907