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

Primary Purpose

Head and Neck Cancer

Status

Unknown status

Phase

Phase 3

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

celecoxib

placebo

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring COX2 inhibitor, head and neck cancer, chemoradiation

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Department of Chemoradiation

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

efficacy of celecoxib (response rate and local control)

Secondary Outcome Measures

toxicity of celecoxib

Full Information

NCT ID

NCT00603759

First Posted

January 16, 2008

Last Updated

January 16, 2008

Sponsor

Tehran University of Medical Sciences

Collaborators

department of radiation oncology

1. Study Identification

Unique Protocol Identification Number

NCT00603759

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2008

Overall Recruitment Status

Unknown status

Study Start Date

April 2006 (undefined)

Primary Completion Date

August 2007 (Actual)

Study Completion Date

August 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Tehran University of Medical Sciences

Collaborators

department of radiation oncology

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Head and Neck Cancer

Keywords

COX2 inhibitor, head and neck cancer, chemoradiation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

122 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Title

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

celecoxib

Intervention Description

100 mg qid

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

1 cap qid

Primary Outcome Measure Information:

Title

efficacy of celecoxib (response rate and local control)

Time Frame

30 months

Secondary Outcome Measure Information:

Title

toxicity of celecoxib

Time Frame

30 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mahdi Aghili, MD

Organizational Affiliation

cancer institute center

Official's Role

Study Chair

Facility Information:

Facility Name

Department of Chemoradiation

City

Tehran

ZIP/Postal Code

1419733141

Country

Iran, Islamic Republic of

12. IPD Sharing Statement

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

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