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A Retrospective Analysis of Neck Dissection Following Complete Response to Chemoradiation in HNSCC

NCT ID: NCT00483821

Last Updated: 2012-09-10

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

COMPLETED

Total Enrollment

165 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-05-31

Study Completion Date

2009-11-30

Brief Summary

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RATIONALE: Gathering disease-related information from medical charts of patients with primary head and neck cancer who have undergone neck dissection after complete response to chemotherapy and radiation therapy may help doctors learn more about the disease and find better methods of treatment.

PURPOSE: This clinical trial is evaluating the medical charts of patients with primary head and neck cancer who have undergone neck dissection after complete response to chemotherapy and radiation therapy.

Detailed Description

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OBJECTIVES:

* Perform a retrospective analysis, by medical chart review, of patients with primary squamous cell carcinoma of the head and neck who underwent neck dissection following complete response to chemoradiotherapy.
* Determine whether the role of a post-chemoradiotherapy neck dissection affects the outcome of the patient's disease, in terms of overall survival, disease-free survival, and recurrence rates.

OUTLINE: This is a pilot, retrospective study.

Patients who have undergone neck dissection after achieving a complete clinical and radiological response to chemoradiotherapy are compared to patients who did not. Data are gathered by medical chart review.

Conditions

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Head and Neck Cancer

Keywords

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stage I squamous cell carcinoma of the hypopharynx stage II squamous cell carcinoma of the hypopharynx stage III squamous cell carcinoma of the hypopharynx stage IV squamous cell carcinoma of the hypopharynx stage I squamous cell carcinoma of the larynx stage II squamous cell carcinoma of the larynx stage III squamous cell carcinoma of the larynx stage IV squamous cell carcinoma of the larynx stage I squamous cell carcinoma of the lip and oral cavity stage II squamous cell carcinoma of the lip and oral cavity stage III squamous cell carcinoma of the lip and oral cavity stage IV squamous cell carcinoma of the lip and oral cavity stage I squamous cell carcinoma of the oropharynx stage II squamous cell carcinoma of the oropharynx stage III squamous cell carcinoma of the oropharynx stage IV squamous cell carcinoma of the oropharynx stage I verrucous carcinoma of the larynx stage II verrucous carcinoma of the larynx stage III verrucous carcinoma of the larynx stage IV verrucous carcinoma of the larynx stage I verrucous carcinoma of the oral cavity stage II verrucous carcinoma of the oral cavity stage III verrucous carcinoma of the oral cavity stage IV verrucous carcinoma of the oral cavity

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Interventions

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medical chart review

medical chart review

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of primary squamous cell carcinoma of the head and neck at any of the following sites:

* Oral cavity
* Oropharynx
* Hypopharynx
* Larynx
* Complete response achieved after treatment with chemoradiotherapy

Exclusion Criteria

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Vanderbilt-Ingram Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Barbara Murphy, MD

Professor of Medicine; Director, Cancer Supportive Care Program; Director, Head and Neck Research Program; Medical Oncologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Barbara Murphy, MD

Role: STUDY_CHAIR

Vanderbilt-Ingram Cancer Center

Locations

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Vanderbilt-Ingram Cancer Center - Cool Springs

Nashville, Tennessee, United States

Site Status

Vanderbilt-Ingram Cancer Center at Franklin

Nashville, Tennessee, United States

Site Status

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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VU-VICC-HN-0435

Identifier Type: -

Identifier Source: secondary_id

VU-VICC-IRB-040428

Identifier Type: -

Identifier Source: secondary_id

VICC HN 0435

Identifier Type: -

Identifier Source: org_study_id