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Prospective Evaluation of Esophageal Pathology Treatment of Head and Neck Carcinoma


N/A
18 Years
N/A
Not Enrolling
Both
Stage I Adenoid Cystic Carcinoma of the Oral Cavity, Stage I Mucoepidermoid Carcinoma of the Oral Cavity, Stage I Squamous Cell Carcinoma of the Hypopharynx, Stage I Squamous Cell Carcinoma of the Larynx, Stage I Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage I Verrucous Carcinoma of the Larynx, Stage I Verrucous Carcinoma of the Oral Cavity, Stage II Adenoid Cystic Carcinoma of the Oral Cavity, Stage II Mucoepidermoid Carcinoma of the Oral Cavity, Stage II Squamous Cell Carcinoma of the Hypopharynx, Stage II Squamous Cell Carcinoma of the Larynx, Stage II Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage II Verrucous Carcinoma of the Larynx, Stage II Verrucous Carcinoma of the Oral Cavity, Stage III Adenoid Cystic Carcinoma of the Oral Cavity, Stage III Mucoepidermoid Carcinoma of the Oral Cavity, Stage III Squamous Cell Carcinoma of the Hypopharynx, Stage III Squamous Cell Carcinoma of the Larynx, Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage III Verrucous Carcinoma of the Larynx, Stage III Verrucous Carcinoma of the Oral Cavity, Stage IV Adenoid Cystic Carcinoma of the Oral Cavity, Stage IV Mucoepidermoid Carcinoma of the Oral Cavity, Stage IV Squamous Cell Carcinoma of the Hypopharynx, Stage IV Squamous Cell Carcinoma of the Larynx, Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage IV Verrucous Carcinoma of the Larynx, Stage IV Verrucous Carcinoma of the Oral Cavity

Thank you

Trial Information

Prospective Evaluation of Esophageal Pathology Treatment of Head and Neck Carcinoma


OBJECTIVES:

I. To assess the prevalence of esophageal pathology (any esophageal abnormality,
specifically: esophagitis, stricture/web, infections, neoplasms) as identified by
esophagoscopy in patients with HNCA before and 3 months following primary radiation and/or
chemotherapy.

II. To assess the changes in self-reported dysphagia symptoms as measured by the Eating
Assessment Tool.

OUTLINE:

Patients undergo transnasal esophagoscopy at baseline and 3 months following completion of
radiation therapy and/or chemotherapy.

Inclusion Criteria


Inclusion

- Written informed consent must be obtained from all participants prior to beginning
therapy; participants should have the ability to understand and be willing to sign a
written informed consent document

- Primary diagnosis of head and neck carcinoma (oral, hypopharyngeal, laryngeal)

- Stage I-IV, undergoing treatment with radiation therapy +/- chemotherapy

Exclusion

- Medical history of esophageal dysfunction

- Pregnant women are not excluded from participation

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Abnormal endoscopic esophageal examination

Outcome Description:

Abnormal endoscopic esophageal examination, as defined by presence of: stricture, web, ring, erosive esophagitis, fungal esophagitis, viral esophagitis, Barrett's metaplasia, neoplasm, or other.

Safety Issue:

No

Principal Investigator

Catherine Rees

Investigator Role:

Principal Investigator

Investigator Affiliation:

Wake Forest University

Authority:

United States: Institutional Review Board

Study ID:

CCCWFU 60110

NCT ID:

NCT01164566

Start Date:

December 2010

Completion Date:

March 2012

Related Keywords:

  • Stage I Adenoid Cystic Carcinoma of the Oral Cavity
  • Stage I Mucoepidermoid Carcinoma of the Oral Cavity
  • Stage I Squamous Cell Carcinoma of the Hypopharynx
  • Stage I Squamous Cell Carcinoma of the Larynx
  • Stage I Squamous Cell Carcinoma of the Lip and Oral Cavity
  • Stage I Verrucous Carcinoma of the Larynx
  • Stage I Verrucous Carcinoma of the Oral Cavity
  • Stage II Adenoid Cystic Carcinoma of the Oral Cavity
  • Stage II Mucoepidermoid Carcinoma of the Oral Cavity
  • Stage II Squamous Cell Carcinoma of the Hypopharynx
  • Stage II Squamous Cell Carcinoma of the Larynx
  • Stage II Squamous Cell Carcinoma of the Lip and Oral Cavity
  • Stage II Verrucous Carcinoma of the Larynx
  • Stage II Verrucous Carcinoma of the Oral Cavity
  • Stage III Adenoid Cystic Carcinoma of the Oral Cavity
  • Stage III Mucoepidermoid Carcinoma of the Oral Cavity
  • Stage III Squamous Cell Carcinoma of the Hypopharynx
  • Stage III Squamous Cell Carcinoma of the Larynx
  • Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity
  • Stage III Verrucous Carcinoma of the Larynx
  • Stage III Verrucous Carcinoma of the Oral Cavity
  • Stage IV Adenoid Cystic Carcinoma of the Oral Cavity
  • Stage IV Mucoepidermoid Carcinoma of the Oral Cavity
  • Stage IV Squamous Cell Carcinoma of the Hypopharynx
  • Stage IV Squamous Cell Carcinoma of the Larynx
  • Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity
  • Stage IV Verrucous Carcinoma of the Larynx
  • Stage IV Verrucous Carcinoma of the Oral Cavity
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Carcinoma, Adenoid Cystic
  • Head and Neck Neoplasms
  • Laryngeal Diseases
  • Carcinoma, Mucoepidermoid
  • Carcinoma, Verrucous
  • Hypopharyngeal Neoplasms
  • Laryngeal Neoplasms

Name

Location

Wake Forest University Health SciencesWinston-Salem, North Carolina  27157