NCT00797498

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
174

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

November 24, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 25, 2008

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

August 14, 2017

Status Verified

August 1, 2017

Enrollment Period

9.3 years

First QC Date

November 24, 2008

Last Update Submit

August 10, 2017

Conditions

Cancers of Nasal CavityCancers of Paranasal Sinuses

Keywords

Nasal CavityParanasal SinusesProton RadiationOutcomes

Outcome Measures

Primary Outcomes (1)

  • Grade 3 or higher of xerostomia Incidence of Xerostomia

    One year after the end of radiation therapy.

Secondary Outcomes (1)

  • Collect and analyze tumor control outcomes

    When each patient has been followed for a minimum of 12 months with final analysis after 24 months.

Study Arms (1)

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

Interventions

Xerostomia questionnaireOTHER

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients in the Radiation Oncology Clinic

You may qualify if:

  • Cancer of nasal cavity and/or paranasal sinuses.
  • Will receive treatment with proton radiation.

You may not qualify if:

  • Evidence of distant metastasis.
  • Previous radiation for head and neck cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida Proton Therapy Institute

Jacksonville, Florida, 32206, United States

Location

Related Publications (15)

  • 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.

    PMID: 2982772BACKGROUND

  • 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.

    PMID: 6690866BACKGROUND

  • 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.

    PMID: 445347BACKGROUND

  • 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.

    PMID: 6331089BACKGROUND

  • 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.

    PMID: 2811551BACKGROUND

  • 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.

    PMID: 9690538BACKGROUND

  • 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.

    PMID: 12439163BACKGROUND

  • 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.

    PMID: 11054520BACKGROUND

  • 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.

    PMID: 9886693BACKGROUND

  • 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.

    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.

    PMID: 12211046BACKGROUND

  • 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.

    PMID: 10547542BACKGROUND

  • 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.

    PMID: 7960976BACKGROUND

  • 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.

    PMID: 7960977BACKGROUND

  • 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.

    PMID: 15990010BACKGROUND

Study Officials

  • Roi Dagan, MD, MS

    University of Florida Proton Therapy Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2008

First Posted

November 25, 2008

Study Start

August 1, 2006

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

August 14, 2017

Record last verified: 2017-08

Locations

US(1)