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

Sponsors and Collaborators:	Tehran University of Medical Sciences department of radiation oncology
Information provided by:	Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:	NCT00603759

Purpose

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 III

MedlinePlus related topics: Cancer Head and Neck Cancer

Drug Information available for: Celecoxib 4-(5-(4-Methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl)benzenesulfonamide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	the Role of COX-2 Inhibitor(CELECOXIB) in Combination With Chemoradiation in Locally Advanced Head & Neck Carcinoma, Phase III Randomized Clinical Trial

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

toxicity of celecoxib [ Time Frame: 30 months ] [ Designated as safety issue: Yes ]

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
1: Active Comparator	Drug: celecoxib 100 mg qid
2: Placebo Comparator	Drug: placebo 1 cap qid

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00603759

Locations

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

Investigators

Study Chair:

Mahdi Aghili, MD

cancer institute center

More Information

Responsible Party:	department of radiation and oncology ( Dr mahdi Aghili )
Study ID Numbers:	3058
Study First Received:	January 16, 2008
Last Updated:	January 16, 2008
ClinicalTrials.gov Identifier:	NCT00603759
Health Authority:	Iran: Ministry of Health

Keywords provided by Tehran University of Medical Sciences:

COX2 inhibitor
head and neck cancer
chemoradiation

Study placed in the following topic categories:

Celecoxib
Head and Neck Neoplasms
Carcinoma

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Physiological Effects of Drugs
Enzyme Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site

Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009