Photon/Proton Beam Radiation Therapy for Carcinoma of the Skin of the Head and Neck - Full Text View

Sponsored by:	University of Florida
Information provided by:	University of Florida
ClinicalTrials.gov Identifier:	NCT00797043

Purpose

You are being asked to take part in this study because you have cancer of the skin of head and neck with perineural invasion and you are going to have photon/proton beam radiotherapy (radiation treatment).

The purpose of this study is to collect information from the questionnaire and your medical records to see what effects the proton beam radiation 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
Head and Neck Cancer	Radiation: Photon/Proton Beam Radiation Therapy

MedlinePlus related topics: Cancer Head and Neck 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 Carcinoma of the Skin of the Head and Neck With Perineural Invasion

Further study details as provided by University of Florida:

Primary Outcome Measures:

Collect and analyze morbidity outcomes: Incidence of xerostomia (dry mouth) [ 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 6 months and then again at 24 months. ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	October 2006
Estimated Study Completion Date:	October 2056
Estimated Primary Completion Date:	October 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:

a) Focal perineural invasion; b) Incidental/positive perineural invasion

Treatment: Photon/Proton radiation per standard of care

Eligibility

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

Criteria

Inclusion Criteria:

Carcinoma of the skin of the head and neck region with perineural invasion.
Biopsy-proven squamous cell carcinoma.
Zubrod performance status 0-1.
Pretreatment evaluation of tumor extent and tumor measurement.
Patients 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.
Must have signed study-specific informed consent.
Age 18 years or older.
Completed all required pretreatment studies per section 4.0 of protocol.

Exclusion Criteria:

Evidence of distant metastasis.
Previous irradiation for head and neck cancer.
Prior chemotherapy less than 6 months prior to study entry.
Other malignancy (except non-melanoma skin cancer) or carcinomas not of head and neck origin and that have not been disease-free for at least 5 years.
Active untreated infection.
Major medical, addictive and/or psychiatric illness that would interfere with either completion of therapy and follow-up or with the consent process.
Pregnant or breast-feeding women, or women and men of child-producing potential not willing to use contraception while on treatment and for at least 3 months thereafter.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00797043

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
Principal Investigator: Robert S Malyapa, MD, PhD

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 0606-SK01
Study First Received:	November 24, 2008
Last Updated:	November 24, 2008
ClinicalTrials.gov Identifier:	NCT00797043
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Florida:

Head and neck skin cancer
Carcinoma of skin of the head and neck.

Study placed in the following topic categories:

Head and Neck Neoplasms
Skin Neoplasms
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 15, 2009