Spinal Cord Compression Clinical Trial
Official title:
Spine Stereotactic Body Radiation Therapy for Metastatic Epidural Spinal Cord: Prospective Phase II Study
Metastatic epidural spinal cord compression (MESCC) is a frequent oncologic emergency that
requires to be treated promptly. Although direct decompressive surgery is the most effective
treatment, surgery is only used in selected patients because most patients have a poor
overall condition and short life expectancy. Radiation therapy (RT), therefore, is the most
commonly used for patients with MESCC, but conventional RT alone can achieve modest
neurologic outcomes.
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.
Status | Recruiting |
Enrollment | 43 |
Est. completion date | August 2015 |
Est. primary completion date | June 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years and older |
Eligibility |
Inclusion Criteria: - MESCC is present. - 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: - Retropulsed bony fragment causing cord compression - Paraplegia = 48 hours - Histology preferred to perform the chemotherapy as the first option (e.g. lymphoma, myeloma) |
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Samsung Medical Center | Seoul |
Lead Sponsor | Collaborator |
---|---|
Samsung Medical Center | Gachon University Gil Medical Center, Seoul National University Hospital |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Neurologic response | Neurologic response is defined as maintaining grade 4 or more motor power after completing SBRT or as an increase of motor power by at least 1 grade from the baseline motor power. There should no decrease of motor power after completing SBRT. The motor weakness is graded from 0 to 5 by Medical Research Council (MRC) scale. |
1 month | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05023772 -
Laser Interstitial Thermal Ablation and Stereotactic Radiosurgery for Patients With Spine Metastases
|
N/A | |
Not yet recruiting |
NCT06077071 -
MRIdian "RADAR" Trial
|
N/A | |
Completed |
NCT02926391 -
UNiD 3D VBR Register
|
||
Not yet recruiting |
NCT02934594 -
Metastatic Spinal Cord Compression (MSCC): Treatment Timing and Survival Rate
|
N/A | |
Completed |
NCT00974168 -
Spinal Cord Compression Re-Treat Study
|
Phase 2 | |
Completed |
NCT00727584 -
Radiation Therapy in Treating Patients With Metastatic Spinal Cord Compression
|
N/A | |
Terminated |
NCT00215527 -
Intrathecal Enzyme Replacement Therapy for Spinal Cord Compression in Mucopolysaccharidosis (MPS) I
|
Phase 1 | |
Completed |
NCT00280306 -
White Matter Fiber Tracking and Assessment of White Matter Integrity in the Cervical Spinal Cord
|
N/A | |
Completed |
NCT02527304 -
Adaptive Staged Stereotactic Body Radiation Therapy in Treating Patients With Spinal Metastases That Cannot Be Removed by Surgery
|
N/A | |
Terminated |
NCT01407341 -
Beta-Tricalcium Phosphate Bone Graft in Treating Patients Undergoing Surgery For Metastatic Spine Cancer
|
Phase 1 | |
Recruiting |
NCT05910593 -
Establishing the Validity and Reliability of a Dexterity Assessment Tool
|
||
Recruiting |
NCT03529708 -
Stereotactic Body Radiotherapy Boost After Palliative Radiotherapy for Spinal Cord Compression
|
N/A | |
Terminated |
NCT02167633 -
Stereotactic Radiosurgery in Metastatic Spinal Cord Compression
|
N/A | |
Enrolling by invitation |
NCT03225625 -
Stem Cell Spinal Cord Injury Exoskeleton and Virtual Reality Treatment Study
|
N/A | |
Completed |
NCT04925882 -
Erector Spinae Plane Block in Lumbar Release Surgery
|
N/A | |
Completed |
NCT02006901 -
Comparative Effectiveness of Microdecompression and Laminectomy for Central Lumbar Spinal Stenosis
|
N/A | |
Terminated |
NCT00786968 -
Extension Study of Intrathecal Enzyme Replacement Therapy for MPS I
|
Phase 1 | |
Completed |
NCT00968643 -
Spinal Cord Compression. ICORG 05-03, V6
|
Phase 3 | |
Recruiting |
NCT05530798 -
CEUS For Intraoperative Spinal Cord Injury
|
N/A | |
Completed |
NCT02713269 -
Thermal Ablation and Spine Stereotactic Radiosurgery in Treating Patients With Spine Metastases at Risk for Compressing the Spinal Cord
|
Phase 2 |