Clinical Trials Logo
  1. Home
  2. Head and Neck Cancer
  3. NCT00603759
  4. Details
NCT00603759 Clinical Trial

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

Head and Neck Cancer Clinical Trial

Official title:
the Role of COX-2 Inhibitor(CELECOXIB) in Combination With Chemoradiation in Locally Advanced Head & Neck Carcinoma, Phase III Randomized Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00603759
Other study ID # 3058
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received January 16, 2008
Last updated January 16, 2008
Start date April 2006
Est. completion date August 2009

Study information
Verified date January 2008
Source Tehran University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority Iran: Ministry of Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 122
Est. completion date August 2009
Est. primary completion date August 2007
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• celecoxib
100 mg qid
• placebo
1 cap qid

Locations
Country Name City State
Iran, Islamic Republic of Department of Chemoradiation Tehran

Sponsors (2)
Lead Sponsor Collaborator
Tehran University of Medical Sciences department of radiation oncology

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary efficacy of celecoxib (response rate and local control) 30 months Yes
Secondary toxicity of celecoxib 30 months Yes
See also
  Status Clinical Trial Phase
Recruiting NCT05808920 - The RESCUE Study: Survival and Functional Outcomes Following Salvage Surgery for RESidual or reCurrent sqUamous cEll Carcinoma of the Head and Neck
Completed NCT02526017 - Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers Phase 1
Active, not recruiting NCT05060432 - Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT03997643 - Preservation of Swallowing in Respected Oral Cavity Squamous Cell Carcinoma: Examining Radiation Volume Effects (PRESERVE): A Randomized Trial Phase 2
Active, not recruiting NCT03170960 - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Recruiting NCT04700475 - Effect of Low Level Laser Therapy on Prevention of Radiotherapy Induced Xerostomia in Cancer Patients. N/A
Withdrawn NCT04058145 - AMD3100 Plus Pembrolizumab in Immune Checkpoint Blockade Refractory Head and Neck Squamous Cell Carcinoma Phase 2
Completed NCT02572869 - Functional and Aesthetic Outcomes After Mandible Reconstruction With Fibula Osteomyocutaneous Free Flaps
Active, not recruiting NCT04474470 - A Study to Evaluate NT219 Alone and in Combination With ERBITUX® (Cetuximab) in Adults With Advanced Solid Tumors and Head and Neck Cancer Phase 1/Phase 2
Withdrawn NCT05073809 - Photoacoustic Imaging of Head and Neck Tumours
Active, not recruiting NCT04383210 - Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors Phase 2
Active, not recruiting NCT03651570 - Randomized Controlled Trial of a E-intervention to Help Patients Newly Diagnosed With Cancer Cope Better: Pilot Study N/A
Recruiting NCT04930432 - Study of MCLA-129, a Human Bispecific EGFR and cMet Antibody, in Patients With Advanced NSCLC and Other Solid Tumors Phase 1/Phase 2
Recruiting NCT06016699 - Immunological Function After Radiation With Either Proton or Photon Therapy
Terminated NCT03843554 - Commensal Oral Microbiota in Head and Neck Cancer N/A
Recruiting NCT05915572 - Mulligan Technique on Shoulder Dysfunction N/A
Completed NCT05897983 - Tens and Rocabado Exercises on TMJ Dysfunction N/A
Not yet recruiting NCT06289049 - Heavy Strength Training in Head and Neck Cancer Survivors Phase 2
Withdrawn NCT05263648 - Virtual Reality Software to Reduce Stress in Cancer Patients N/A
Withdrawn NCT03238638 - A Study of Epacadostat + Pembrolizumab in Head and Neck Cancer Patients, Who Failed Prior PD-1/PD-L1 Therapy Phase 2