Status:
COMPLETED
Gefitinib (Iressa) in Combo With Chemoradiation in Patients With Locally Advanced Head & Neck Cancer
Lead Sponsor:
AstraZeneca
Conditions:
Head and Neck Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
To determine the safety and tolerability of gefitinib in combination with cisplatin and radiation (3D-CRT or IMRT) in patients with locally advanced head and neck cancer.
Eligibility Criteria
Inclusion
- Histologically confirmed head and neck cancer
- Lymph node negative or positive
- Metastasis negative
- Chemo- and radiotherapy naïve
- WHO 0-2
- Measurable disease by RECIST
- Written informed consent
Exclusion
- Severe alcohol abuse
- Active ILD
- Co-existing chronic gastrointestinal disease(s)
- Brain metastasis
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
End Date :
March 1 2006
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00239304
Start Date
June 1 2003
End Date
March 1 2006
Last Update
December 18 2007
Active Locations (1)
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1
Research Centre
Helsinki, Finland