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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2008 by Tehran University of Medical Sciences.
Recruitment status was:  Active, not recruiting
department of radiation oncology
Information provided by:
Tehran University of Medical Sciences Identifier:
First received: January 16, 2008
Last updated: NA
Last verified: January 2008
History: No changes posted

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.

Condition Intervention Phase
Head and Neck Cancer Drug: celecoxib Drug: placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: the Role of COX-2 Inhibitor(CELECOXIB) in Combination With Chemoradiation in Locally Advanced Head & Neck Carcinoma, Phase III Randomized Clinical Trial

Resource links provided by NLM:

Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:
  • efficacy of celecoxib (response rate and local control) [ Time Frame: 30 months ]

Secondary Outcome Measures:
  • toxicity of celecoxib [ Time Frame: 30 months ]

Enrollment: 122
Study Start Date: April 2006
Estimated Study Completion Date: August 2009
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: celecoxib
100 mg qid
Placebo Comparator: 2 Drug: placebo
1 cap qid


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00603759

Iran, Islamic Republic of
Department of Chemoradiation
Tehran, Iran, Islamic Republic of, 1419733141
Sponsors and Collaborators
Tehran University of Medical Sciences
department of radiation oncology
Study Chair: Mahdi Aghili, MD cancer institute center
  More Information

Responsible Party: Dr mahdi Aghili, department of radiation and oncology Identifier: NCT00603759     History of Changes
Other Study ID Numbers: 3058
Study First Received: January 16, 2008
Last Updated: January 16, 2008

Keywords provided by Tehran University of Medical Sciences:
COX2 inhibitor
head and neck cancer

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents processed this record on September 21, 2017