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

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00797043

Acronym

SK01

Enrollment

Registered

2008-11-25

Start date

2008-09-30

Completion date

2015-07-31

Last updated

2017-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Neoplasm of Skin Head and Neck

Keywords

Carcinoma of the skin of the head and neck, Proton radiation, Outcomes

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results