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

This study has been terminated.
(Slow enrollment, feasibility issues)
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT00797043
First received: November 24, 2008
Last updated: July 29, 2015
Last verified: July 2015
  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
Malignant Neoplasm of Skin 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

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: No ]

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 ]

Enrollment: 11
Study Start Date: September 2008
Study Completion Date: July 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Photon/Proton Radiation Therapy
Data consolidation and analysis

Detailed Description:

Data collection will be obtained from the patient's medical records including initial evaluation, pathology report, dosimetry information, radiotherapy completion records and follow-up.

  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

Locations
United States, Florida
University of Florida Proton Therapy Institute
Jacksonville, Florida, United States, 32206
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Roi Dagan, MD, MS University of Florida Proton Therapy Institute
  More Information

Additional Information:
Publications:

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: July 29, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
Carcinoma of the skin of the head and neck
Proton radiation
Outcomes

Additional relevant MeSH terms:
Neoplasms
Skin Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on August 27, 2015