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

Cancers of Nasal Cavity Clinical Trial

— SI01  

Official title:

A Clinical Outcomes Protocol of Photon/Proton Beam Radiation Therapy for Cancers of the Nasal Cavity and/or Paranasal Sinuses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00797498
• Other study ID #: UFPTI 0604-SI01
• Status: Completed
• Phase: N/A
• First received: November 24, 2008
• Last updated: August 10, 2017
• Start date: August 2006
• Est. completion date: December 2015

Study information

• Verified date: August 2017
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancers of Nasal Cavity
• Cancers of Paranasal Sinuses
• Paranasal Sinus Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	University of Florida Proton Therapy Institute	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

References & Publications (15)

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. — View Citation

Ellingwood KE, Million RR. Cancer of the nasal cavity and ethmoid/sphenoid sinuses. Cancer. 1979 Apr;43(4):1517-26. — View Citation

Gadeberg CC, Hjelm-Hansen M, Søgaard H, Elbrønd O. Malignant tumours of the paranasal sinuses and nasal cavity. A series of 180 patients. Acta Radiol Oncol. 1984;23(2-3):181-7. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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.

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Grade 3 or higher of xerostomia Incidence of Xerostomia		One year after the end of radiation therapy.
Secondary	Collect and analyze tumor control outcomes		When each patient has been followed for a minimum of 12 months with final analysis after 24 months.

External Links

•   Contact the University of Florida Proton Therapy Institute