NCT00603759

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
122

participants targeted

Target at P25-P50 for phase_3 head-and-neck-cancer

Timeline
Completed

Started Apr 2006

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 29, 2008

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

January 29, 2008

Status Verified

January 1, 2008

Enrollment Period

1.3 years

First QC Date

January 16, 2008

Last Update Submit

January 16, 2008

Conditions

Head and Neck Cancer

Keywords

COX2 inhibitorhead and neck cancerchemoradiation

Outcome Measures

Primary Outcomes (1)

  • efficacy of celecoxib (response rate and local control)

    30 months

Secondary Outcomes (1)

  • toxicity of celecoxib

    30 months

Study Arms (2)

1

ACTIVE COMPARATOR
Drug: celecoxib

2

PLACEBO COMPARATOR
Drug: placebo

Interventions

celecoxibDRUG

100 mg qid

1
placeboDRUG

1 cap qid

2

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • stage III/IV (locally advanced) carcinoma of oropharynx, oral cavity, hypopharynx, larynx, or nasopharynx
  • primary treatment with chemoradiation

You may not qualify if:

  • distant metastasis
  • incomplete treatment
  • adjuvant chemoradiation after surgery without apparent tumor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Chemoradiation

Tehran, Tehran Province, 1419733141, Iran

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Mahdi Aghili, MD

    cancer institute center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 16, 2008

First Posted

January 29, 2008

Study Start

April 1, 2006

Primary Completion

August 1, 2007

Study Completion

August 1, 2009

Last Updated

January 29, 2008

Record last verified: 2008-01

Locations

IR(1)