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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02332408 |
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Date of registration:
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04/01/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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CyberKnife Based Hypofractionated Radiotherapy for Vertebral Hemangiomas
CKHRTVH |
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Scientific title:
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CyberKnife Based Hypofractionated Radiotherapy Versus Conventional Linac Based Radiotherapy for Painful Vertebral Hemangiomas - Controlled Randomized Clinical Trial. |
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Date of first enrolment:
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September 2014 |
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Target sample size:
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80 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02332408 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Poland
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Contacts
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Name:
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Leszek MIszczyk, MD. PhD |
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Address:
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Telephone:
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+48322788001 |
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Email:
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leszek@io.gliwice.pl |
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Affiliation:
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Name:
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Leszek Miszczyk, MD, PhD |
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Address:
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Telephone:
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0048322788001 |
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Email:
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leszek@io.gliwice.pl |
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Affiliation:
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Name:
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Leszek Miszczyk, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch, Gliwice, Poland |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Confirmed vertebral hemangioma ,
2. Lesion visible in CT and MR
3. Pain located in area of the lesion
4. Informed consent for participation in the study and for radiotherapy in interested
area
Exclusion Criteria:
1. Any previous radiotherapy in region of treated hemangioma
2. Spinal damage or disease that may be associated with an increased radiosensitivity
3. The coexistence of the vertebral morphological changes at the level of hemangioma
causing pressure on the nerve roots and / or spinal cord causing pain located in that
area
4. Neurological deficits caused by the presence of hemangioma (patients should be
considered for surgery)
5. Contradictions for MRI
6. Lack of informed consent.
Age minimum:
25 Years
Age maximum:
85 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hemangioma of Vertebral Column
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Intervention(s)
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Radiation: Conventional radiotherapy
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Radiation: Cybernetic microradiosurgery
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Primary Outcome(s)
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Analgetic effect
[Time Frame: 2 years]
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Secondary Outcome(s)
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Identification of radiologic prognostic and predictal factors of response to external beam radiotherapy (radiosurgery compared to conventional)
[Time Frame: 2 years]
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Identification of biochemical and physical prognostic factors of response to external beam radiotherapy (radiosurgery compared to conventional)
[Time Frame: 2 years]
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Secondary ID(s)
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HRVH-COI-03
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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