Photon/Proton Radiation Therapy for Carcinoma of the Skin of the Head and Neck (SK01)
This study is currently recruiting participants.
Verified March 2013 by University of Florida
Sponsor:
University of Florida
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT00797043
First received: November 24, 2008
Last updated: March 26, 2013
Last verified: March 2013
| Tracking Information | |||||
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| First Received Date ICMJE | November 24, 2008 | ||||
| Last Updated Date | March 26, 2013 | ||||
| Start Date ICMJE | September 2008 | ||||
| Estimated Primary Completion Date | October 2056 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE |
Collect and analyze morbidity outcomes: Incidence of xerostomia (dry mouth) [ Time Frame: Every 4 months until the final analysis. ] [ Designated as safety issue: Yes ] | ||||
| Change History | Complete list of historical versions of study NCT00797043 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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 ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Photon/Proton Radiation Therapy for Carcinoma of the Skin of the Head and Neck | ||||
| Official Title ICMJE | A Clinical Outcomes Protocol of Photon/Proton Beam Radiation Therapy for Carcinoma of the Skin of the Head and Neck With Perineural Invasion | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients treated at radiation oncology clinic |
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| Condition ICMJE | Skin Cancer of the Head and Neck | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Photon/Proton Radiation Therapy
Data consolidation and analysis |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 174 | ||||
| Estimated Completion Date | October 2058 | ||||
| Estimated Primary Completion Date | October 2056 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00797043 | ||||
| Other Study ID Numbers ICMJE | UFPTI 0606-SK01 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | University of Florida | ||||
| Study Sponsor ICMJE | University of Florida | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Florida | ||||
| Verification Date | March 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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