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

Tehran University of Medical Sciences

Status and phase: Unknown; Phase 3

Conditions: Head and Neck Cancer

Treatments: Drug: placebo; Drug: celecoxib

Study type: Interventional

Funder types: Other

Identifiers

NCT00603759

3058

Details and patient eligibility

About

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.

Enrollment: 122 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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122 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Treatment:

Drug: celecoxib

2

Placebo Comparator group

Treatment:

Drug: placebo