This trial is active, not recruiting.

Condition head and neck cancer
Treatments celecoxib, placebo
Phase phase 3
Sponsor Tehran University of Medical Sciences
Collaborator department of radiation oncology
Start date April 2006
End date August 2007
Trial size 122 participants
Trial identifier NCT00603759, 3058


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
(Active Comparator)
100 mg qid
(Placebo Comparator)
1 cap qid

Primary Outcomes

efficacy of celecoxib (response rate and local control)
time frame: 30 months

Secondary Outcomes

toxicity of celecoxib
time frame: 30 months

Eligibility Criteria

Male or female participants at least 20 years old.

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

Additional Information

Official title the Role of COX-2 Inhibitor(CELECOXIB) in Combination With Chemoradiation in Locally Advanced Head & Neck Carcinoma, Phase III Randomized Clinical Trial
Trial information was received from ClinicalTrials.gov and was last updated in January 2008.
Information provided to ClinicalTrials.gov by Tehran University of Medical Sciences.