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

Overview

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.

Full Title of Study: “the Role of COX-2 Inhibitor(CELECOXIB) in Combination With Chemoradiation in Locally Advanced Head & Neck Carcinoma, Phase III Randomized Clinical Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: August 2007

Interventions

  • Drug: celecoxib
    • 100 mg qid
  • Drug: placebo
    • 1 cap qid

Arms, Groups and Cohorts

  • Active Comparator: 1
  • Placebo Comparator: 2

Clinical Trial Outcome Measures

Primary Measures

  • efficacy of celecoxib (response rate and local control)
    • Time Frame: 30 months

Secondary Measures

  • toxicity of celecoxib
    • Time Frame: 30 months

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Tehran University of Medical Sciences
  • Collaborator
    • department of radiation oncology
  • Provider of Information About this Clinical Study
    • Dr mahdi Aghili, department of radiation and oncology
  • Overall Official(s)
    • Mahdi Aghili, MD, Study Chair, cancer institute center

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