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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer

Thank you

Trial Information

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


Inclusion Criteria:



- adult patients, >=18 years of age;

- high risk totally resected head and neck squamous cell cancer: T3-T4 or N2-N3;

- ECOG <=2.

Exclusion Criteria:

- macroscopic residual disease after surgery;

- previous treatment with anti-EGFR.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Progression-free survival

Outcome Time Frame:

Event driven

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Spain: Ministry of Health

Study ID:

ML20294

NCT ID:

NCT00412217

Start Date:

November 2006

Completion Date:

December 2009

Related Keywords:

  • Head and Neck Cancer
  • Carcinoma, Squamous Cell
  • Neoplasms, Squamous Cell
  • Head and Neck Neoplasms

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