Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01826058
Other study ID # KROG 1316
Secondary ID
Status Recruiting
Phase Phase 2
First received April 3, 2013
Last updated November 27, 2014
Start date October 2012
Est. completion date August 2015

Study information

Verified date November 2014
Source Samsung Medical Center
Contact Doo Ho Choi, MD. PhD.
Phone 82-2-3410-2436
Email doho.choi@samsung.com
Is FDA regulated No
Health authority South Korea: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.


Description:

The definition of metastatic epidural spinal cord compression (MESCC)

- 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.


Recruitment information / eligibility

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)

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Radiation:
Stereotactic body radiation therapy


Locations

Country Name City State
Korea, Republic of Samsung Medical Center Seoul

Sponsors (3)

Lead Sponsor Collaborator
Samsung Medical Center Gachon University Gil Medical Center, Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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
See also
  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
Not yet recruiting NCT02934594 - Metastatic Spinal Cord Compression (MSCC): Treatment Timing and Survival Rate N/A
Completed NCT02926391 - UNiD 3D VBR Register
Completed NCT00974168 - Spinal Cord Compression Re-Treat Study Phase 2
Completed NCT00727584 - Radiation Therapy in Treating Patients With Metastatic Spinal Cord Compression N/A
Completed NCT00280306 - White Matter Fiber Tracking and Assessment of White Matter Integrity in the Cervical Spinal Cord N/A
Terminated NCT00215527 - Intrathecal Enzyme Replacement Therapy for Spinal Cord Compression in Mucopolysaccharidosis (MPS) I Phase 1
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