Spine Stereotactic Body Radiation Therapy for Metastatic Epidural Spinal Cord Compression
NCT ID: NCT01826058
Last Updated: 2014-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
43 participants
INTERVENTIONAL
2012-10-31
2015-08-31
Brief Summary
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The hypothesis to use stereotactic body radiation therapy (SBRT) for MESCC is that the rapid decompression of epidural mass, durable local control and subsequently improved neurologic outcomes compared to conventional RT are expected when MESCC is treated with SBRT.
Detailed Description
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* MESCC is defined as both an evidence of cord compression by radiologic evaluation and a manifestation of clinical feature at the level of cord compression.
* A cord compression by radiologic evaluation is defined as \< 3mm gap between epidural mass and true spinal cord or indentation of thecal sac at the level of clinical feature by MRI.
* Clinical features include any or all of the followings: pain (local or radicular) or motor weakness or sensory change or incontinence.
Simulation -A Computed tomography (CT) scan will be acquired with the use of intravenous contrast and planning MRI will be also performed on the same day of simulation.
Spine SBRT
\- One to four sessions of SBRT will be performed.
Follow-up
* Patients need to be assessed at 1 week, 1 month and 3 months after the completion of SBRT and will be followed up at 3 month intervals thereafter.
* Pain score, neurologic examination, adverse events and simple X-ray of involved spine should be evaluated at every follow-up visit.
* MRI of involved spine will be performed at 3 months after the completion of SBRT.
Up to 43 patients will be enrolled in this study in Samsung Medical Center, Seoul National University Hospital, and Gachon University Gil Medical Center.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Stereotactic body radiation therapy
SBRT in one to four fractions
Irradiated total RT dose to gross tumor volume (GTV) according to fraction size
* 1 fx: 16 to 24 Gy
* 2 fx's: 20 to 26 Gy
* 3 fx's: 21 to 30 Gy
* 4 fx's: 24 to 36 Gy
Stereotactic body radiation therapy
Interventions
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Stereotactic body radiation therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Localized spine metastases (C1 to L5 level); Maximum 3 separate sites and maximum 2 contiguous vertebral bodies
* Performance state before the occurrence of neurologic symptoms : Eastern Cooperative Oncology Group 0-2
* Age ≥20
* MRI within 2 weeks is mandatory
* Paraspinal mass \< 5cm in maximum dimension
* Inoperable patients - refused or medically unfit for decompression surgery
* life expectancy \> 3 months
Exclusion Criteria
* Paraplegia ≥ 48 hours
* Histology preferred to perform the chemotherapy as the first option (e.g. lymphoma, myeloma)
20 Years
ALL
No
Sponsors
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Seoul National University Hospital
OTHER
Gachon University Gil Medical Center
OTHER
Samsung Medical Center
OTHER
Responsible Party
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Doo Ho Choi
Professor, Department of Radiation Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine
Locations
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Samsung Medical Center
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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KROG 1316
Identifier Type: -
Identifier Source: org_study_id