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Spine Stereotactic Body Radiation Therapy for Metastatic Epidural Spinal Cord: Prospective Phase II Study


Phase 2
20 Years
N/A
Open (Enrolling)
Both
Metastatic Epidural Spinal Cord Compression

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Trial Information

Spine Stereotactic Body Radiation Therapy for Metastatic Epidural Spinal Cord: Prospective Phase II Study


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


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

- Planning MRI is mandatory

- Paraspinal mass < 5cm in maximum dimension

- Inoperable patients - refused or medically unfit for decompression surgery

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)

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Neurologic response

Outcome Description:

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.

Outcome Time Frame:

1 month

Safety Issue:

No

Authority:

South Korea: Institutional Review Board

Study ID:

SMC IRB(2012-08-088-001)

NCT ID:

NCT01826058

Start Date:

October 2012

Completion Date:

Related Keywords:

  • Metastatic Epidural Spinal Cord Compression
  • Stereotactic body radiation therapy
  • Radiosurgery
  • Spinal Cord Compression

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