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OpenTrials
Completed

NCT Number: NCT00797498

Photon/Proton Radiation Therapy for Cancers of the Nasal Cavity and/or Paranasal Sinuses

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.

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Florida Proton Therapy Institute

Jacksonville, Florida, 32206, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Xerostomia questionnaire

Other

All of the tests, procedures and treatments may be considered standard of care for someone with this type of cancer, except for the Xerostomia Questionnaire.

Primary outcomes

  1. Grade 3 or higher of xerostomia Incidence of Xerostomia

    Time frame: One year after the end of radiation therapy.

Secondary outcomes

  1. Collect and analyze tumor control outcomes

    Time frame: When each patient has been followed for a minimum of 12 months with final analysis after 24 months.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

A Clinical Outcomes Protocol of Photon/Proton Beam Radiation Therapy for Cancers of the Nasal Cavity and/or Paranasal Sinuses

Acronym: SI01

Important dates

Study start
2006
Primary completion
2015
Study completion
2015
First posted
Nov 25, 2008
Registry last updated
Aug 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.