- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00603759
COX-2 Inhibitor With Concurrent Chemoradiation in Locally Advanced Head & Neck Carcinoma
the Role of COX-2 Inhibitor(CELECOXIB) in Combination With Chemoradiation in Locally Advanced Head & Neck Carcinoma, Phase III Randomized Clinical Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Tehran, Iran, Islamic Republic of, 1419733141
- Department of Chemoradiation
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 2
|
1 cap qid
|
Active Comparator: 1
|
100 mg qid
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
efficacy of celecoxib (response rate and local control)
Time Frame: 30 months
|
30 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
toxicity of celecoxib
Time Frame: 30 months
|
30 months
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Mahdi Aghili, MD, cancer institute center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Neoplasms by Site
- Head and Neck Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Cyclooxygenase 2 Inhibitors
- Celecoxib
Other Study ID Numbers
- 3058
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Head and Neck Cancer
-
Robert FerrisAmgenCompletedHead and Neck Cancer | Cancer of Head and Neck | Head Cancer | Neck Cancer | Neoplasms, Head and Neck | Cancer of the Head and Neck | Cancer of Neck | Upper Aerodigestive Tract Neoplasms | Neck Neoplasms | Cancer of the Head | Cancer of the Neck | UADT Neoplasms | Cancer of Head | Head Neoplasms | Head, Neck Neoplasms | Neoplasms, Head and other conditionsUnited States
-
Assiut UniversityRecruitingHead and Neck Cancer | Head and Neck Neoplasms | Cancer of Head and Neck | Neoplasms, Head and Neck | Cancer of the Head and NeckEgypt
-
Mayo ClinicRecruitingCancer Head Neck | Cancer Neck | Cancer, HeadUnited States
-
IRCCS Policlinico S. MatteoNestlé Health Science Spain; Akern SrlCompletedHead-neck CancerItaly
-
University of California, San FranciscoCompleted
-
Chinook Therapeutics, Inc. (formerly Aduro)TerminatedRecurrent Head and Neck Cancer | Metastatic Head and Neck CancerUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)TerminatedHead And Neck CancerUnited States
-
National Cancer Institute (NCI)TerminatedRecurrent Head and Neck Cancer | Metastatic Head and Neck CancerUnited States
-
Radboud University Medical CenterUnknown
-
Centre Oscar LambretUnknownEpidermoid Head and Neck CancerFrance
Clinical Trials on celecoxib
-
Chong Kun Dang PharmaceuticalCompletedOsteoarthritis HandKorea, Republic of
-
Pfizer's Upjohn has merged with Mylan to form Viatris...CompletedHealthy VolunteersSingapore
-
Yooyoung Pharmaceutical Co., Ltd.CliPS Co., LtdCompletedOsteoarthritis, KneeKorea, Republic of
-
Samsung Medical CenterThe Korean Urological AssociationWithdrawnBenign Prostatic HyperplasiaKorea, Republic of
-
Yooyoung Pharmaceutical Co., Ltd.CliPSBnCRecruitingOsteoarthritis, KneeKorea, Republic of
-
Seoul National University HospitalCompletedIntracerebral HemorrhageKorea, Republic of
-
Dr. Reddy's Laboratories LimitedCompleted
-
Xintian PharmaceuticalNot yet recruiting
-
Amsterdam UMC, location VUmcNetherlands Brain FoundationRecruitingInflammation | Depressive Disorder, MajorNetherlands
-
Targeted Therapy Technologies, LLCRecruitingMacula Edema | Epiretinal Membrane | Branch Retinal Vein Occlusion | Radiation Retinopathy | Central Serous Retinopathy With Pit of Optic Disc | Commotio Retinae | VitritisUnited States