Photon/Proton Radiation Therapy for Cancers of the Nasal Cavity and/or Paranasal Sinuses - Full Text View

Sponsored by:	University of Florida
Information provided by:	University of Florida
ClinicalTrials.gov Identifier:	NCT00797498

Purpose

You are being asked to take part in this study because you have cancer of the nasal cavity/ paranasal sinus and you are going to have photon/proton beam radiotherapy (radiation treatment).

The purpose of this study is to collect information from a questionnaire and medical records to see what effects proton beam radiation has on cancer and collect and analyze morbidity outcomes: incidence of Xerostomia (dry mouth) and tumor control.

Protons may offer a unique advantage. It may be possible to design treatments where surrounding or non-tumor-overlapping tissues could be spared.

Condition	Intervention
Cancers of Nasal Cavity and or Paranasal Sinuses	Radiation: Photon/Proton Beam Radiation Therapy

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Clinical Outcomes Protocol of Photon/Proton Beam Radiation Therapy for Cancers of the Nasal Cavity and/or Paranasal Sinuses

Further study details as provided by University of Florida:

Primary Outcome Measures:

Collect and analyze morbidity outcomes: Incidence of Xerostomia [ Time Frame: Every 4 months until the final analysis. ] [ 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:	100
Study Start Date:	August 2006
Estimated Study Completion Date:	August 2056
Estimated Primary Completion Date:	August 2056 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Photon/Proton Beam Radiation Therapy: Experimental	Radiation: Photon/Proton Beam Radiation Therapy Photon/Proton Beam Radiation Therapy per standard of care.

Detailed Description:

If you take part in this study, you will be asked eight questions about dry mouth symptoms that you may have. Answering these questions will take less than 10 minutes. You will have the standard treatment for your type of cancer, which has been determined by your cancer doctors.

Patients will be stratified:

Pre-op XRT;
Post-op XRT;
Inoperable

Treatment: Photon/Proton radiation will be given per standard of care

Chemotherapy and surgery will be performed at the discretion of the patient's physicians.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Tumors of nasal cavity and/or paranasal sinuses (excluding vestibule).
Biopsy-proven squamous cell carcinoma, adenocarcinoma, adenoid cystic, undifferentiated sinonasal, mucoepidermoid, melanoma or esthesioneuroblastoma.
Zubrod performance status 0-1.
Pretreatment evaluation of tumor extent and tumor measurement.
Willing to follow instructions (e.g. avoid smoking/alcohol) and keep appointments.
Nutritional and general physical condition must be considered compatible with the proposed treatment.
Patients receiving chemotherapy should have a pretreatment WBC greater than or equal to 4000 and a platelet count of greater than or equal to 100,000; patients must have adequate renal function as documented by creatinine clearance greater than or equal to 60 ml/min (actual or calculated by the Cockroft-Gault method).
Signed informed consent.

Exclusion Criteria:

Evidence of distant metastasis.
Previous irradiation for head and neck cancer.
Other malignancy that has not been disease-free for at least 5 years, except non-melanoma skin cancer.
Active untreated infection.
Major medical, addictive and/or psychiatric illness that would interfere with the consent process, treatment and/or follow-up compliance.
Pregnant or breast-feeding women, or women and men of child-producing potential not willing to use contraception during treatment and for at least 3 months thereafter.

Contacts and Locations

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

Contacts

Contact: Amanda D Prince, RN	(904)588-1298	aprince@floridaproton.org
Contact: Cindy L Carroll	(904)588-1288	ccarroll@floridaproton.org

Locations

United States, Florida
University of Florida Proton Therapy Institute	Recruiting
Jacksonville, Florida, United States, 32206
Contact: Amanda D Prince, RN 904-588-1298 aprince@floridaproton.org
Contact: Cindy L Carroll (904)588-1288 ccarroll@floridaproton.org

Sponsors and Collaborators

University of Florida

Investigators

Principal Investigator:

Robert S Malyapa, MD, PhD

University of Florida Proton Therapy Institute

More Information

Responsible Party:	University of Florida Proton Therapy Institute ( Robert S. Malyapa, MD, PhD )
Study ID Numbers:	UFPTI 0604-SI01
Study First Received:	November 24, 2008
Last Updated:	November 24, 2008
ClinicalTrials.gov Identifier:	NCT00797498
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Florida:

Nasal Cavity
Paranasal Sinuses

Study placed in the following topic categories:

Tooth Diseases
Stomatognathic Diseases
Dental Caries

Additional relevant MeSH terms:

Tooth Demineralization

ClinicalTrials.gov processed this record on January 15, 2009