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

This study is currently recruiting participants.
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

November 24, 2008
March 11, 2014
September 2008
October 2056   (final data collection date for primary outcome measure)
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 ]
Collect and analyze morbidity outcomes: Incidence of xerostomia (dry mouth) [ Time Frame: Every 4 months until the final analysis. ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00797043 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Photon/Proton Radiation Therapy for Carcinoma of the Skin of the Head and Neck
A Clinical Outcomes Protocol of Photon/Proton Beam Radiation Therapy for Carcinoma of the Skin of the Head and Neck With Perineural Invasion

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients treated at radiation oncology clinic

Skin Cancer of the Head and Neck
Not Provided
Photon/Proton Radiation Therapy
Data consolidation and analysis

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
174
October 2058
October 2056   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Intake Coordinator 877-686-6009
United States
 
NCT00797043
UFPTI 0606-SK01
No
University of Florida
University of Florida
Not Provided
Principal Investigator: Roi Dagan, MD, MS University of Florida Proton Therapy Institute
University of Florida
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP