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Sponsored by: |
University of Florida |
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Information provided by: | University of Florida |
ClinicalTrials.gov Identifier: | NCT00797498 |
You are being asked to take part in this study because you have cancer of the nasal cavity/ paranasal sinus and you are going to have photon/proton beam radiotherapy (radiation treatment).
The purpose of this study is to collect information from a questionnaire and medical records to see what effects proton beam radiation has on cancer and collect and analyze morbidity outcomes: incidence of Xerostomia (dry mouth) and tumor control.
Protons may offer a unique advantage. It may be possible to design treatments where surrounding or non-tumor-overlapping tissues could be spared.
Condition | Intervention |
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Cancers of Nasal Cavity and or Paranasal Sinuses |
Radiation: Photon/Proton Beam Radiation Therapy |
Study Type: | Interventional |
Study Design: | Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Clinical Outcomes Protocol of Photon/Proton Beam Radiation Therapy for Cancers of the Nasal Cavity and/or Paranasal Sinuses |
Estimated Enrollment: | 100 |
Study Start Date: | August 2006 |
Estimated Study Completion Date: | August 2056 |
Estimated Primary Completion Date: | August 2056 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Photon/Proton Beam Radiation Therapy: Experimental |
Radiation: Photon/Proton Beam Radiation Therapy
Photon/Proton Beam Radiation Therapy per standard of care.
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If you take part in this study, you will be asked eight questions about dry mouth symptoms that you may have. Answering these questions will take less than 10 minutes. You will have the standard treatment for your type of cancer, which has been determined by your cancer doctors.
Patients will be stratified:
Treatment: Photon/Proton radiation will be given per standard of care
Chemotherapy and surgery will be performed at the discretion of the patient's physicians.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Amanda D Prince, RN | (904)588-1298 | aprince@floridaproton.org |
Contact: Cindy L Carroll | (904)588-1288 | ccarroll@floridaproton.org |
United States, Florida | |
University of Florida Proton Therapy Institute | Recruiting |
Jacksonville, Florida, United States, 32206 | |
Contact: Amanda D Prince, RN 904-588-1298 aprince@floridaproton.org | |
Contact: Cindy L Carroll (904)588-1288 ccarroll@floridaproton.org |
Principal Investigator: | Robert S Malyapa, MD, PhD | University of Florida Proton Therapy Institute |
Responsible Party: | University of Florida Proton Therapy Institute ( Robert S. Malyapa, MD, PhD ) |
Study ID Numbers: | UFPTI 0604-SI01 |
Study First Received: | November 24, 2008 |
Last Updated: | November 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00797498 |
Health Authority: | United States: Institutional Review Board |
Nasal Cavity Paranasal Sinuses |
Tooth Diseases Stomatognathic Diseases Dental Caries |
Tooth Demineralization |