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
ConditionsMalignant Neoplasm of Skin Head and Neck
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.
Investigators
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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