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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2008 by Tehran University of Medical Sciences.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
department of radiation oncology
Information provided by:
Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT00603759
First received: January 16, 2008
Last updated: NA
Last verified: January 2008
History: No changes posted
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

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

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

No publications provided

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

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

Additional relevant MeSH terms:
Carcinoma
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Celecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Central Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 16, 2013