NCT00483821

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
165

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2004

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

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

May 1, 2004

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

June 6, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 7, 2007

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

September 10, 2012

Status Verified

September 1, 2012

Enrollment Period

5.5 years

First QC Date

June 6, 2007

Last Update Submit

September 7, 2012

Conditions

Head and Neck Cancer

Keywords

stage I squamous cell carcinoma of the hypopharynxstage II squamous cell carcinoma of the hypopharynxstage III squamous cell carcinoma of the hypopharynxstage IV squamous cell carcinoma of the hypopharynxstage I squamous cell carcinoma of the larynxstage II squamous cell carcinoma of the larynxstage III squamous cell carcinoma of the larynxstage IV squamous cell carcinoma of the larynxstage I squamous cell carcinoma of the lip and oral cavitystage II squamous cell carcinoma of the lip and oral cavitystage III squamous cell carcinoma of the lip and oral cavitystage IV squamous cell carcinoma of the lip and oral cavitystage I squamous cell carcinoma of the oropharynxstage II squamous cell carcinoma of the oropharynxstage III squamous cell carcinoma of the oropharynxstage IV squamous cell carcinoma of the oropharynxstage I verrucous carcinoma of the larynxstage II verrucous carcinoma of the larynxstage III verrucous carcinoma of the larynxstage IV verrucous carcinoma of the larynxstage I verrucous carcinoma of the oral cavitystage II verrucous carcinoma of the oral cavitystage III verrucous carcinoma of the oral cavitystage IV verrucous carcinoma of the oral cavity

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    off-study date

Secondary Outcomes (2)

  • Disease-free survival

    off-study date

  • Recurrence rate

    off-study date

Interventions

medical chart reviewOTHER

medical chart review

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • Not specified
  • PRIOR CONCURRENT THERAPY:
  • See Disease Characteristics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Vanderbilt-Ingram Cancer Center - Cool Springs

Nashville, Tennessee, 37064, United States

Location

Vanderbilt-Ingram Cancer Center at Franklin

Nashville, Tennessee, 37064, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsSquamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Barbara Murphy, MD

    Vanderbilt-Ingram Cancer Center

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine; Director, Cancer Supportive Care Program; Director, Head and Neck Research Program; Medical Oncologist

Study Record Dates

First Submitted

June 6, 2007

First Posted

June 7, 2007

Study Start

May 1, 2004

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

September 10, 2012

Record last verified: 2012-09

Locations

US(3)