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A Study of Tarceva (Erlotinib) in Patients With Resected Head and Neck Squamous Cell Cancer.

Head and Neck Cancer Clinical Trial

Official title:
A Randomized, Open Label, Study of the Effect of Tarceva on Progression Free Survival When Given as Maintenance Treatment Following Concurrent Chemo-radiotherapy or Radiotherapy Alone in Patients With Resected Head and Neck Squamous Cell Cancer

Clinical Trial Summary

This 2 arm study will compare the efficacy and safety of Tarceva, versus standard of care, in patients with resected head and neck squamous cell cancer who are receiving concurrent chemo-radiotherapy or radiotherapy alone. Patients will be randomized to receive either Tarceva 150mg po daily or standard of care. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00412217
Study type Interventional
Source Hoffmann-La Roche
Contact
Status Terminated
Phase Phase 3
Start date November 2006
Completion date December 2009
View Details
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