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Clinical Trials/NCT00797043
NCT00797043
Terminated
Not Applicable

A Clinical Outcomes Protocol of Photon/Proton Beam Radiation Therapy for Carcinoma of the Skin of the Head and Neck With Perineural Invasion

University of Florida1 site in 1 country11 target enrollmentSeptember 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Malignant Neoplasm of Skin Head and Neck
Sponsor
University of Florida
Enrollment
11
Locations
1
Primary Endpoint
Collect and analyze morbidity outcomes: Incidence of grade 3 or higher xerostomia (dry mouth)
Status
Terminated
Last Updated
9 years ago

Overview

Brief Summary

The purpose of this study is to collect information from the questionnaire and your medical records to see what effects the proton radiation has on you and your cancer and collect and analyze morbidity outcomes: Incidence of xerostomia (dry mouth) and tumor control.

Detailed Description

Data collection will be obtained from the patient's medical records including initial evaluation, pathology report, dosimetry information, radiotherapy completion records and follow-up.

Registry
clinicaltrials.gov
Start Date
September 2008
End Date
July 2015
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Carcinoma of the skin of the head and neck region with incidental or symptomatic perineural invasion.
  • Biopsy-proven squamous cell carcinoma.
  • Will receive treatment with proton radiation.

Exclusion Criteria

  • Evidence of distant metastasis.
  • Previous irradiation for head and neck cancer.

Outcomes

Primary Outcomes

Collect and analyze morbidity outcomes: Incidence of grade 3 or higher xerostomia (dry mouth)

Time Frame: 1 year following the completion of radiation therapy

Secondary Outcomes

  • Collect and analyze tumor control outcomes.(When each patient has been followed for a minimum of 6 months and then again at 24 months.)

Study Sites (1)

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