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

• Status: Unknown status
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tehran University of Medical Sciences
• Collaborator: department of radiation oncology
• Treatments: Celecoxib; Cyclooxygenase 2 Inhibitors

Criteria

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