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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00797043
Recruitment Status : Terminated (Slow enrollment, feasibility issues)
First Posted : November 25, 2008
Last Update Posted : February 7, 2017
Sponsor:
Information provided by (Responsible Party):
University of Florida

Study Description
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Brief Summary:
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 or disease
Malignant Neoplasm of Skin Head and Neck

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.
Study Design
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Study Type : Observational
Actual Enrollment : 11 participants
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
Study Start Date : September 2008
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015
Groups and Cohorts
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Group/Cohort
Photon/Proton Radiation Therapy
Data consolidation and analysis


Outcome Measures
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Primary Outcome Measures :
  1. Collect and analyze morbidity outcomes: Incidence of grade 3 or higher xerostomia (dry mouth) [ Time Frame: 1 year following the completion of radiation therapy ]

Secondary Outcome Measures :
  1. 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. ]

Eligibility Criteria
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Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00797043


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

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00797043    
Other Study ID Numbers: UFPTI 0606-SK01
First Posted: November 25, 2008    Key Record Dates
Last Update Posted: February 7, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by University of Florida:
Carcinoma of the skin of the head and neck
Proton radiation
Outcomes
Additional relevant MeSH terms:
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Carcinoma
Neoplasms
Skin Neoplasms
Neoplasms, Glandular and Epithelial
 Neoplasms by Histologic Type
Neoplasms by Site
Skin Diseases