Trial Information
the Role of COX-2 Inhibitor(CELECOXIB) in Combination With Chemoradiation in Locally Advanced Head & Neck Carcinoma, Phase III Randomized Clinical Trial
Inclusion Criteria:
- stage III/IV (locally advanced) carcinoma of oropharynx, oral cavity, hypopharynx,
larynx, or nasopharynx
- primary treatment with chemoradiation
Exclusion Criteria:
- distant metastasis
- incomplete treatment
- adjuvant chemoradiation after surgery without apparent tumor
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
efficacy of celecoxib (response rate and local control)
Outcome Time Frame:
30 months
Safety Issue:
Yes
Principal Investigator
Mahdi Aghili, MD
Investigator Role:
Study Chair
Investigator Affiliation:
cancer institute center
Authority:
Iran: Ministry of Health
Study ID:
3058
NCT ID:
NCT00603759
Start Date:
April 2006
Completion Date:
August 2009
Related Keywords:
- Head and Neck Cancer
- COX2 inhibitor
- head and neck cancer
- chemoradiation
- Carcinoma
- Head and Neck Neoplasms