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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00603759
Recruitment Status : Unknown
Verified January 2008 by Tehran University of Medical Sciences.
Recruitment status was:  Active, not recruiting
First Posted : January 29, 2008
Last Update Posted : January 29, 2008
department of radiation oncology
Information provided by:
Tehran University of Medical Sciences

Brief 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.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Drug: celecoxib Drug: placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
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
Study Start Date : April 2006
Actual Primary Completion Date : August 2007
Estimated Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Celecoxib
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1 Drug: celecoxib
100 mg qid
Placebo Comparator: 2 Drug: placebo
1 cap qid

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

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

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: Dr mahdi Aghili, department of radiation and oncology Identifier: NCT00603759     History of Changes
Other Study ID Numbers: 3058
First Posted: January 29, 2008    Key Record Dates
Last Update Posted: January 29, 2008
Last Verified: January 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