Photon/Proton Radiation Therapy for Carcinoma of the Skin of the Head and Neck (SK01)

February 3, 2017 updated by: University of Florida

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

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.

Study Overview

Status

Terminated

Conditions

Malignant Neoplasm of Skin Head and Neck

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.

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Florida
  - Jacksonville, Florida, United States, 32206
    - University of Florida Proton Therapy Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients treated at radiation oncology clinic

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
Photon/Proton Radiation Therapy Data consolidation and analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Collect and analyze morbidity outcomes: Incidence of grade 3 or higher xerostomia (dry mouth) Time Frame: 1 year following the completion of radiation therapy	1 year following the completion of radiation therapy

Secondary Outcome Measures

Outcome Measure	Time Frame
Collect and analyze tumor control outcomes. Time Frame: When each patient has been followed for a minimum of 6 months and then again at 24 months.	When each patient has been followed for a minimum of 6 months and then again at 24 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

November 24, 2008

First Submitted That Met QC Criteria