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Photon/Proton Radiation Therapy for Cancers of the Nasal Cavity and/or Paranasal Sinuses (SI01)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00797498
Recruitment Status : Completed
First Posted : November 25, 2008
Last Update Posted : August 14, 2017
Sponsor:
Information provided by (Responsible Party):
University of Florida

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.

Condition or disease Intervention/treatment
Cancers of Nasal Cavity Cancers of Paranasal Sinuses Other: Xerostomia questionnaire

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.

Study Type : Observational
Actual Enrollment : 174 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Clinical Outcomes Protocol of Photon/Proton Beam Radiation Therapy for Cancers of the Nasal Cavity and/or Paranasal Sinuses
Study Start Date : August 2006
Primary Completion Date : December 2015
Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dry Mouth
U.S. FDA Resources

Group/Cohort Intervention/treatment
Xerostomia Questionnaire
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.
Other: Xerostomia questionnaire
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 Outcome Measures :
  1. Grade 3 or higher of xerostomia Incidence of Xerostomia [ Time Frame: One year after the end of radiation therapy. ]

Secondary Outcome Measures :
  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. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients in the Radiation Oncology Clinic
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00797498


Locations
United States, Florida
University of Florida Proton Therapy Institute
Jacksonville, Florida, United States, 32206
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Roi Dagan, MD, MS University of Florida Proton Therapy Institute

Additional Information:
Publications:
Parsons, J.T., Mendenhall, W.M., Stringer, S.P., Cassisi, N.J. & Million, R.R.: Nasal cavity and paranasal sinuses. In: Perez CA, Brady LW, eds. Principles and practice of radiation oncology, 3rd ed. Lippincott-Raven Publishers, Philadelphia; 1997, p. 941-959.

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00797498     History of Changes
Other Study ID Numbers: UFPTI 0604-SI01
First Posted: November 25, 2008    Key Record Dates
Last Update Posted: August 14, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by University of Florida:
Nasal Cavity
Paranasal Sinuses
Proton Radiation
Outcomes

Additional relevant MeSH terms:
Paranasal Sinus Neoplasms
Nose Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Nose Diseases
Respiratory Tract Diseases
Paranasal Sinus Diseases
Respiratory Tract Neoplasms
Otorhinolaryngologic Diseases