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

NCT ID: NCT00797498

Last Updated: 2017-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

174 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-08-31

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cancers of Nasal Cavity Cancers of Paranasal Sinuses

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Xerostomia questionnaire

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Roi Dagan, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Florida Proton Therapy Institute

Locations

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University of Florida Proton Therapy Institute

Jacksonville, Florida, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 2982772 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 6690866 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 445347 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 6331089 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2811551 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9690538 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12439163 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11054520 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9886693 (View on PubMed)

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 12211046 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10547542 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7960976 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7960977 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15990010 (View on PubMed)

Other Identifiers

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UFPTI 0604-SI01

Identifier Type: -

Identifier Source: org_study_id

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