Head and Neck Cancer
Conditions
Keywords
COX2 inhibitor, head and neck cancer, chemoradiation
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.
Interventions
DRUGcelecoxib
100 mg qid
DRUGplacebo
1 cap qid
Sponsors
department of radiation oncology
Tehran University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy of celecoxib (response rate and local control) | 30 months |
Secondary
| Measure | Time frame |
|---|---|
| toxicity of celecoxib | 30 months |
Countries
Iran
Outcome results
None listed