MedTrace Logo

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

NCT00603759 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2008-01-29

No results posted yet for this study

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.

Conditions

Interventions

DRUG

celecoxib

100 mg qid

DRUG

placebo

1 cap qid

Sponsors & Collaborators

  • department of radiation oncology

    collaborator AMBIG

  • Tehran University of Medical Sciences

    lead OTHER

Principal Investigators

  • Mahdi Aghili, MD · cancer institute center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-04-30
Primary Completion
2007-08-31
Completion
2009-08-31

Countries

  • Iran

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00603759 on ClinicalTrials.gov