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

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ClinicalTrials.gov Identifier: NCT00797498

Recruitment Status : Completed

First Posted : November 25, 2008

Last Update Posted : August 14, 2017

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

University of Florida

Study Description

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 Design

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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
Actual Primary Completion Date :	December 2015
Actual Study Completion Date :	December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dry Mouth

U.S. FDA Resources

Groups and Cohorts

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.

Outcome Measures

Primary Outcome Measures :

Grade 3 or higher of xerostomia Incidence of Xerostomia [ Time Frame: One year after the end of radiation therapy. ]

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. ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
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.

Contacts and Locations

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

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United States, Florida
University of Florida Proton Therapy Institute
Jacksonville, Florida, United States, 32206

Sponsors and Collaborators

University of Florida

Investigators

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Principal Investigator:	Roi Dagan, MD, MS	University of Florida Proton Therapy Institute

More 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 Mar;11(3):505-9. doi: 10.1016/0360-3016(85)90181-6.

Shidnia H, Hornback NB, Saghafi N, Sayoc E, Lingeman R, Hamaker R. The role of radiation therapy in the treatment of malignant tumors of the paranasal sinuses. Laryngoscope. 1984 Jan;94(1):102-6. doi: 10.1002/lary.5540940119.

Ellingwood KE, Million RR. Cancer of the nasal cavity and ethmoid/sphenoid sinuses. Cancer. 1979 Apr;43(4):1517-26. doi: 10.1002/1097-0142(197904)43:43.0.co;2-b.

Gadeberg CC, Hjelm-Hansen M, Sogaard H, Elbrond O. Malignant tumours of the paranasal sinuses and nasal cavity. A series of 180 patients. Acta Radiol Oncol. 1984;23(2-3):181-7. doi: 10.3109/02841868409136009.

Lavertu P, Roberts JK, Kraus DH, Levine HL, Wood BG, Medendorp SV, Tucker HM. Squamous cell carcinoma of the paranasal sinuses: the Cleveland Clinic experience 1977-1986. Laryngoscope. 1989 Nov;99(11):1130-6. doi: 10.1288/00005537-198911000-00005.

Paulino AC, Marks JE, Bricker P, Melian E, Reddy SP, Emami B. Results of treatment of patients with maxillary sinus carcinoma. Cancer. 1998 Aug 1;83(3):457-65.

Myers LL, Nussenbaum B, Bradford CR, Teknos TN, Esclamado RM, Wolf GT. Paranasal sinus malignancies: an 18-year single institution experience. Laryngoscope. 2002 Nov;112(11):1964-9. doi: 10.1097/00005537-200211000-00010.

Waldron JN, O'Sullivan B, Gullane P, Witterick IJ, Liu FF, Payne D, Warde P, Cummings B. Carcinoma of the maxillary antrum: a retrospective analysis of 110 cases. Radiother Oncol. 2000 Nov;57(2):167-73. doi: 10.1016/s0167-8140(00)00256-5.

Jiang GL, Morrison WH, Garden AS, Geara F, Callender D, Goepfert H, Ang KK. Ethmoid sinus carcinomas: natural history and treatment results. Radiother Oncol. 1998 Oct;49(1):21-7. doi: 10.1016/s0167-8140(98)00075-9.

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 TS, Mendenhall WM, Morris CG, Amdur RJ, Hinerman RW, Villaret DB. Malignant tumors of the nasal cavity and paranasal sinuses. Head Neck. 2002 Sep;24(9):821-9. doi: 10.1002/hed.10143.

Le QT, Fu KK, Kaplan M, Terris DJ, Fee WE, Goffinet DR. Treatment of maxillary sinus carcinoma: a comparison of the 1997 and 1977 American Joint Committee on cancer staging systems. Cancer. 1999 Nov 1;86(9):1700-11.

Parsons JT, Bova FJ, Fitzgerald CR, Mendenhall WM, Million RR. Radiation optic neuropathy after megavoltage external-beam irradiation: analysis of time-dose factors. Int J Radiat Oncol Biol Phys. 1994 Nov 15;30(4):755-63. doi: 10.1016/0360-3016(94)90346-8.

Parsons JT, Bova FJ, Fitzgerald CR, Mendenhall WM, Million RR. Radiation retinopathy after external-beam irradiation: analysis of time-dose factors. Int J Radiat Oncol Biol Phys. 1994 Nov 15;30(4):765-73. doi: 10.1016/0360-3016(94)90347-6.

Bhandare N, Monroe AT, Morris CG, Bhatti MT, Mendenhall WM. Does altered fractionation influence the risk of radiation-induced optic neuropathy? Int J Radiat Oncol Biol Phys. 2005 Jul 15;62(4):1070-7. doi: 10.1016/j.ijrobp.2004.12.009.

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Responsible Party:	University of Florida
ClinicalTrials.gov Identifier:	NCT00797498
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:

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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

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