Photon/Proton Radiation Therapy for Carcinoma of the Skin of the Head and Neck (SK01)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of Florida
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT00797043
First received: November 24, 2008
Last updated: March 11, 2014
Last verified: March 2014
  Purpose

The purpose of this study is to collect information from the questionnaire and your medical records to see what effects the proton radiation has on you and your cancer and collect and analyze morbidity outcomes: Incidence of xerostomia (dry mouth) and tumor control.


Condition
Skin Cancer of the Head and Neck

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Collect and analyze morbidity outcomes: Incidence of grade 3 or higher xerostomia (dry mouth) [ Time Frame: 1 year following the completion of radiation therapy ] [ 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: 174
Study Start Date: September 2008
Estimated Study Completion Date: October 2058
Estimated Primary Completion Date: October 2056 (Final data collection date for primary outcome measure)
Groups/Cohorts
Photon/Proton Radiation Therapy
Data consolidation and analysis

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients treated at radiation oncology clinic

Criteria

Inclusion Criteria:

  • Carcinoma of the skin of the head and neck region with incidental or symptomatic perineural invasion.
  • Biopsy-proven squamous cell carcinoma.
  • Will receive treatment with proton radiation.

Exclusion Criteria:

  • Evidence of distant metastasis.
  • Previous irradiation for head and neck cancer.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Intake Coordinator 877-686-6009

Locations
United States, Florida
University of Florida Proton Therapy Institute Recruiting
Jacksonville, Florida, United States, 32206
Contact: Intake Coordinator    877-686-6009      
Principal Investigator: Roi Dagan, MD, MS         
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Roi Dagan, MD, MS University of Florida Proton Therapy Institute
  More Information

Additional Information:
Publications:
Bhandare N, Monroe AT, Morris CG, Bhatti TM, Mendenhall WM. Does altered fractionation influence the risk of radiation-induced optic neuropathy? Int J Radiat Oncol Biol Phys. 62: 1070-1077, 2005

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00797043     History of Changes
Other Study ID Numbers: UFPTI 0606-SK01
Study First Received: November 24, 2008
Last Updated: March 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
Head and neck skin cancer
Proton radiation
Outcomes

Additional relevant MeSH terms:
Carcinoma
Skin Neoplasms
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on August 19, 2014