NCT01826058

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
43

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2012

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 8, 2013

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

December 2, 2014

Status Verified

November 1, 2014

Enrollment Period

2.7 years

First QC Date

April 3, 2013

Last Update Submit

November 27, 2014

Conditions

Spinal Cord Compression

Keywords

Stereotactic body radiation therapyRadiosurgery

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Stereotactic body radiation therapy

EXPERIMENTAL

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

Interventions

Stereotactic body radiation therapyRADIATION
Also known as: Radiosurgery, SRS, Radiation, Radiotherapy, Metastatic Epidural Spinal Cord Compression, MESCC
Stereotactic body radiation therapy

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Retropulsed bony fragment causing cord compression
  • Paraplegia ≥ 48 hours
  • Histology preferred to perform the chemotherapy as the first option (e.g. lymphoma, myeloma)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

RECRUITING

MeSH Terms

Conditions

Spinal Cord Compression

Interventions

RadiosurgeryRadiationRadiotherapy

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesSpinal Cord InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

TherapeuticsStereotaxic TechniquesNeurosurgical ProceduresSurgical Procedures, OperativeInvestigative TechniquesPhysical Phenomena

Central Study Contacts

Doo Ho Choi, MD. PhD.

CONTACT

82-2-3410-2436doho.choi@samsung.com

Donryul Oh, MD

CONTACT

82-2-3410-2613dongryuloh@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Department of Radiation Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine

Study Record Dates

First Submitted

April 3, 2013

First Posted

April 8, 2013

Study Start

October 1, 2012

Primary Completion

June 1, 2015

Study Completion

August 1, 2015

Last Updated

December 2, 2014

Record last verified: 2014-11

Locations

KR(1)