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

NCT ID: NCT00603759

Last Updated: 2008-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2009-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Head and Neck Cancer

Keywords

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COX2 inhibitor head and neck cancer chemoradiation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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1

Group Type ACTIVE_COMPARATOR

celecoxib

Intervention Type DRUG

100 mg qid

2

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

1 cap qid

Interventions

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celecoxib

100 mg qid

Intervention Type DRUG

placebo

1 cap qid

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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department of radiation oncology

AMBIG

Sponsor Role collaborator

Tehran University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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department of radiation and oncology

Principal Investigators

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Mahdi Aghili, MD

Role: STUDY_CHAIR

cancer institute center

Locations

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Department of Chemoradiation

Tehran, Tehran Province, Iran

Site Status

Countries

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Iran

Other Identifiers

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3058

Identifier Type: -

Identifier Source: org_study_id