Malignant Neoplasm of Skin Head and Neck Clinical Trial
— SK01Official title:
A Clinical Outcomes Protocol of Photon/Proton Beam Radiation Therapy for Carcinoma of the Skin of the Head and Neck With Perineural Invasion
| Verified date | February 2017 |
| Source | University of Florida |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Terminated |
| Enrollment | 11 |
| Est. completion date | July 2015 |
| Est. primary completion date | July 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Florida Proton Therapy Institute | Jacksonville | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| University of Florida |
United States,
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BALLANTYNE AJ, MCCARTEN AB, IBANEZ ML. THE EXTENSION OF CANCER OF THE HEAD AND NECK THROUGH PERIPHERAL NERVES. Am J Surg. 1963 Oct;106:651-67. — View Citation
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Mendenhall WM, Parsons JT, Mendenhall NP, Million RR. T2-T4 carcinoma of the skin of the head and neck treated with radical irradiation. Int J Radiat Oncol Biol Phys. 1987 Jul;13(7):975-81. — View Citation
Parsons JT, Bova FJ, Fitzgerald CR, Mendenhall WM, Million RR. Radiation optic neuropathy after megavoltage external-beam irradiation: analysis of time-dose factors. Int J Radiat Oncol Biol Phys. 1994 Nov 15;30(4):755-63. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Collect and analyze morbidity outcomes: Incidence of grade 3 or higher xerostomia (dry mouth) | 1 year following the completion of radiation therapy | ||
| Secondary | Collect and analyze tumor control outcomes. | When each patient has been followed for a minimum of 6 months and then again at 24 months. |