Conformal High Dose Intensity Modulated Radiation Therapy for Disease to Thoracic and Lumbar Spine
Tracking Information | |||||
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First Received Date ICMJE | July 17, 2012 | ||||
Last Updated Date | July 30, 2012 | ||||
Start Date ICMJE | December 2009 | ||||
Estimated Primary Completion Date | December 2014 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Time to any skeletal related event [ Time Frame: up to 24 months ] [ Designated as safety issue: No ] Time to any skeletal related event most commonly symptomatic recurrence or progression with pain/neurologic impairment with evidence of radiographic progression. |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT01654068 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Conformal High Dose Intensity Modulated Radiation Therapy for Disease to Thoracic and Lumbar Spine | ||||
Official Title ICMJE | Conformal High Dose Intensity Modulated Radiation Therapy for Asymptomatic Metastatic Disease to the Thoracic and Lumbar Spine | ||||
Brief Summary | The purpose of this study is to determine if Conformal High Dose Intensity Modulated Radiation Therapy is an appropriate option for treating cancer that has spread to the spinal column. This study involves patients who have been diagnosed with metastatic cancer to the thoracic and lumbar vertebral body levels and currently do not have symptoms caused from the area of concern. The goal is to prove that this is not only a safe form of treatment, but that Conformal High Dose Intensity Modulated Radiation Therapy can reduce the risk of cancer coming back in the area that the investigators treat which may reduce the risk of developing symptoms like pain in the future. |
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Detailed Description | |||||
Study Type ICMJE | Interventional | ||||
Study Phase | Phase 2 | ||||
Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE | Vertebral Metastasis | ||||
Intervention ICMJE | Radiation: Conformal High Dose Intensity Modulated Radiation Therapy
Conformal High Dose Intensity Modulated Radiation Therapy 14Gy single fraction dosing using 6MV photons |
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Study Arm (s) |
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Publications * | |||||
* 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 | 25 | ||||
Estimated Completion Date | December 2015 | ||||
Estimated Primary Completion Date | December 2014 (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 | NCT01654068 | ||||
Other Study ID Numbers ICMJE | 09-RAD-01 | ||||
Has Data Monitoring Committee | Yes | ||||
Responsible Party | University of Kentucky | ||||
Study Sponsor ICMJE | University of Kentucky | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | University of Kentucky | ||||
Verification Date | July 2012 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |