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

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ClinicalTrials.gov Identifier: NCT00483821
Recruitment Status : Completed
First Posted : June 7, 2007
Last Update Posted : September 10, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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.


Condition or disease Intervention/treatment
Head and Neck Cancer Other: medical chart review

Detailed Description:

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.


Study Design

Study Type : Observational
Actual Enrollment : 165 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: A Retrospective Analysis of Neck Dissection Following Complete Response to Chemoradiation in HNSCC
Study Start Date : May 2004
Primary Completion Date : November 2009
Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Intervention Details:
    Other: medical chart review
    medical chart review

Outcome Measures

Primary Outcome Measures :
  1. Overall survival [ Time Frame: off-study date ]

Secondary Outcome Measures :
  1. Disease-free survival [ Time Frame: off-study date ]
  2. Recurrence rate [ Time Frame: off-study date ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adults with the diagnosis of primary squamous cell carcinoma of the head and neck at any of the following sites:

  • Oral cavity
  • Oropharynx
  • Hypopharynx
  • Larynx
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00483821


Locations
United States, Tennessee
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, United States, 37064
Vanderbilt-Ingram Cancer Center at Franklin
Nashville, Tennessee, United States, 37064
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Investigators
Study Chair: Barbara Murphy, MD Vanderbilt-Ingram Cancer Center
More Information

Responsible Party: Barbara Murphy, MD, Professor of Medicine; Director, Cancer Supportive Care Program; Director, Head and Neck Research Program; Medical Oncologist, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT00483821     History of Changes
Other Study ID Numbers: VICC HN 0435
VU-VICC-HN-0435
VU-VICC-IRB-040428
First Posted: June 7, 2007    Key Record Dates
Last Update Posted: September 10, 2012
Last Verified: September 2012

Keywords provided by Barbara Murphy, MD, Vanderbilt-Ingram Cancer Center:
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

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms