Clinical trial NCT01826058: Spine Stereotactic Body Radiation Therapy for Metastatic Epidural Spinal Cord Compression
Official title: Spine Stereotactic Body Radiation Therapy for Metastatic Epidural Spinal Cord: Prospective Phase II Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Spinal Cord Compression
Keywords: Stereotactic body radiation therapy
Radiosurgery
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Seoul National University Hospital
name: Gachon University Gil Medical Center
First posted: 2013-04-08
Enrollment: 43
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Neurologic response
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References: