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

NCT00412217 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2016-11-25

Study results available
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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 chemoradiotherapy or radiotherapy alone. Participants will be randomized to receive either erlotinib 150 milligrams (mg) orally (PO) once daily or placebo for 1 year until disease progression or unacceptable toxicity.

Conditions

Interventions

DRUG

Placebo

Participants will receive placebo tablets (matched to erlotinib) once daily.

DRUG

Erlotinib

Erlotinib will be given as 150 mg PO once daily.

OTHER

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.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • Spain

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00412217 on ClinicalTrials.gov