Spine Stereotactic Body Radiation Therapy for Metastatic Epidural Spinal Cord Compression

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.

Study Overview

• Status: Unknown
• Conditions: Spinal Cord Compression
• Intervention / Treatment: Radiation: Stereotactic body radiation therapy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 43
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 135-710
    • Recruiting
    • Samsung Medical Center
    • Contact: Doo Ho Choi, MD.PhD.; Phone Number: 82-2-3410-2436; Email: doho.choi@samsung.com
    • Contact: Dongryul Oh, MD; Phone Number: 82-2-3410-2615; Email: dongryuloh@gmail.com
    • Principal Investigator: Doo Ho Choi, MD.PhD.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Radiation: Stereotactic body radiation therapy; Other Names: Radiation; Radiotherapy; Radiosurgery; SRS; Metastatic Epidural Spinal Cord Compression; MESCC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Collaborators: Seoul National University Hospital; Gachon University Gil Medical Center

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Anticipated): June 1, 2015
• Study Completion (Anticipated): August 1, 2015

Study Registration Dates

• First Submitted: April 3, 2013
• First Submitted That Met QC Criteria: April 5, 2013
• First Posted (Estimate): April 8, 2013

Study Record Updates

• Last Update Posted (Estimate): December 2, 2014
• Last Update Submitted That Met QC Criteria: November 27, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: Stereotactic body radiation therapy; Radiosurgery
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Spinal Cord Diseases; Spinal Cord Injuries; Spinal Cord Compression
• Other Study ID Numbers: KROG 1316