Clinical trial NCT00797498: Photon/Proton Radiation Therapy for Cancers of the Nasal Cavity and/or Paranasal Sinuses
Official title: A Clinical Outcomes Protocol of Photon/Proton Beam Radiation Therapy for Cancers of the Nasal Cavity and/or Paranasal Sinuses
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancers of Nasal Cavity
Cancers of Paranasal Sinuses
Keywords: Nasal Cavity
Paranasal Sinuses
Proton Radiation
Outcomes
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2008-11-25
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in the Radiation Oncology Clinic

Brief summary: The purpose of this study is to collect information from a questionnaire and medical records to see what effects proton radiation has on cancer and collect and analyze morbidity outcomes: incidence of Xerostomia (dry mouth) and tumor control.

Detailed description: The study is non interventional outcomes protocol designed to collect information from a questionnaire and medical records to see what effects proton radiation has on cancer and collect and analyze morbidity outcomes: incidence of Xerostomia (dry mouth) and tumor control.

Eligibility criteria: Inclusion Criteria:

* Cancer of nasal cavity and/or paranasal sinuses.
* Will receive treatment with proton radiation.

Exclusion Criteria:

* Evidence of distant metastasis.
* Previous radiation for head and neck cancer.

Primary outcomes:
measure: Grade 3 or higher of xerostomia Incidence of Xerostomia
timeFrame: One year after the end of radiation therapy.
Secondary outcomes:
measure: Collect and analyze tumor control outcomes
timeFrame: When each patient has been followed for a minimum of 12 months with final analysis after 24 months.
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: University of Florida Proton Therapy Institute
state: Florida
Study officials:
affiliation: University of Florida Proton Therapy Institute
name: Roi Dagan, MD, MS
role: PRINCIPAL_INVESTIGATOR
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