drugset / Trial / NCT00603759

COX-2 Inhibitor With Concurrent Chemoradiation in Locally Advanced Head & Neck Carcinoma

NCT00603759

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2006-04
Primary completion
2007-08
Completion
2009-08

Drugs

EvaluationDrugModalityDoseRoute
Comparator Celecoxib Other / unclassified 100 mg

Indications