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

Last updated: January 16, 2008
Sponsor: Tehran University of Medical Sciences
Overall Status: Trial Status Unknown

Phase

3

Condition

Human Papilloma Virus (Hpv)

Head And Neck Cancer

Nasopharyngeal Cancer

Treatment

N/A

Clinical Study ID

NCT00603759
3058
  • Ages > 20
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • stage III/IV (locally advanced) carcinoma of oropharynx, oral cavity, hypopharynx,larynx, or nasopharynx

  • primary treatment with chemoradiation

Exclusion

Exclusion Criteria:

  • distant metastasis

  • incomplete treatment

  • adjuvant chemoradiation after surgery without apparent tumor

Study Design

Total Participants: 122
Study Start date:
April 01, 2006
Estimated Completion Date:
August 31, 2009

Connect with a study center

  • Department of Chemoradiation

    Tehran, 1419733141
    Iran, Islamic Republic of

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.