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

Information source: University of Florida
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Malignant Neoplasm of Skin Head and Neck

Phase: N/A

Status: Terminated

Sponsored by: University of Florida

Official(s) and/or principal investigator(s):
Roi Dagan, MD, MS, Principal Investigator, Affiliation: University of Florida Proton Therapy Institute

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.

Clinical Details

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

Study design: Observational Model: Cohort, Time Perspective: Prospective

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

Secondary outcome: Collect and analyze tumor control outcomes.

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

University of Florida Proton Therapy Institute, Jacksonville, Florida 32206, United States
Additional Information

Contact the University of Florida Proton Therapy Institute

Related publications:

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.

Cottel WI. Perineural invasion by squamous-cell carcinoma. J Dermatol Surg Oncol. 1982 Jul;8(7):589-600.

Mendenhall WM, Parsons JT, Mendenhall NP, Brant TA, Stringer SP, Cassisi NJ, Million RR. Carcinoma of the skin of the head and neck with perineural invasion. Head Neck. 1989 Jul-Aug;11(4):301-8.

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.

Al-Othman MO, Mendenhall WM, Amdur RJ. Radiotherapy alone for clinical T4 skin carcinoma of the head and neck with surgery reserved for salvage. Am J Otolaryngol. 2001 Nov-Dec;22(6):387-90.

Mendenhall WM, Amdur RJ, Williams LS, Mancuso AA, Stringer SP, Price Mendenhall N. Carcinoma of the skin of the head and neck with perineural invasion. Head Neck. 2002 Jan;24(1):78-83. Review.

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.

Bhandare N, Monroe AT, Morris CG, Bhatti MT, Mendenhall WM. Does altered fractionation influence the risk of radiation-induced optic neuropathy? Int J Radiat Oncol Biol Phys. 2005 Jul 15;62(4):1070-7.

Mendenhall WM, Amdur RJ, Siemann DW, Parsons JT. Altered fractionation in definitive irradiation of squamous cell carcinoma of the head and neck. Curr Opin Oncol. 2000 May;12(3):207-14. Review.

Starting date: September 2008
Last updated: July 29, 2015

Page last updated: August 23, 2015

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