Trial record 18 of 19 for:    Open Studies | "Paranasal Sinus Neoplasms"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of Florida
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT00797498
First received: November 24, 2008
Last updated: March 11, 2014
Last verified: March 2014
  Purpose

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 Intervention
Cancers of Nasal Cavity
Cancers of Paranasal Sinuses
Other: Xerostomia questionnaire

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Grade 3 or higher of xerostomia Incidence of Xerostomia [ Time Frame: One year after the end of radiation therapy. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Estimated Enrollment: 174
Study Start Date: August 2006
Estimated Study Completion Date: August 2058
Estimated Primary Completion Date: August 2056 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00797498

Contacts
Contact: Intake Coordinator 877-686-6009

Locations
United States, Florida
University of Florida Proton Therapy Institute Recruiting
Jacksonville, Florida, United States, 32206
Contact: Intake Coordinator    877-686-6009      
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Roi Dagan, MD, MS University of Florida Proton Therapy Institute
  More Information

Additional Information:
Publications:
Korzeniowski. S., Reinfuss, M. & Skolyszewski, J.: The evaluation of radiotherapy after incomplete surgery in patients with carcinoma of the maxillary sinus. Int J Radiat Oncol Biol Phys. 1985; 11:505-509.
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.
Katz, T.S., Mendenhall, W.M., Morris, C.G., Amdur, R.J., Hinerman, R.W. & Villaret, D.B.: Malignant tumors of the nasal cavity and paranasal sinuses. Head & Neck 2002; 24:821-829.
Parsons, J.T., Bova, F.J., Fitzgerald, C.R., Mendenhall & W.M., Million, R.R.: Radiation retinopathy after external-beam irradiation: Analysis of time-dose factors. Int J Radiat Oncol Biol Phys. 1994; 30: 765-773.
Bhandare, N., Monroe, A.T., Morris, C.G., Bhatti, M.T. & Mendenhall, W.M.: Does altered fractionation influence the risk of radiation-induced optic neuropathy? Int J Radiat Oncol Biol. 2005; 62:1070-1077.

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00797498     History of Changes
Other Study ID Numbers: UFPTI 0604-SI01
Study First Received: November 24, 2008
Last Updated: March 11, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 28, 2014