COX-2 Inhibitor With Concurrent Chemoradiation in Locally Advanced Head & Neck Carcinoma
- Registration Number
- NCT00603759
- Lead Sponsor
- Tehran University of Medical Sciences
- Brief Summary
chemotherapy- and radiotherapy-induced oral mucositis represents a therapeutic challenge frequently encountered in cancer patients.This side effect causes significant morbidity and may delay or interrupt the treatment plan, as well reduce therapeutic index. cyclo-oxygenase 2 (COX-2) is an inducible enzyme primarily expressed in inflamed tissues and tumor. COX-2 inhibitors have shown promise as radio- and chemosensitizer and reduce radio-induced toxicities.
we have conducted a phase III, randomized double blind clinical trial to evaluate the toxicity and efficacy of celecoxib, a selective COX-2 inhibitor, administered concurrently with chemotherapy, and radiation for locally advanced head and neck cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 122
- stage III/IV (locally advanced) carcinoma of oropharynx, oral cavity, hypopharynx, larynx, or nasopharynx
- primary treatment with chemoradiation
- distant metastasis
- incomplete treatment
- adjuvant chemoradiation after surgery without apparent tumor
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 celecoxib - 2 placebo -
- Primary Outcome Measures
Name Time Method efficacy of celecoxib (response rate and local control) 30 months
- Secondary Outcome Measures
Name Time Method toxicity of celecoxib 30 months
Trial Locations
- Locations (1)
Department of Chemoradiation
🇮🇷Tehran, Iran, Islamic Republic of