Surgical Versus Nonoperative Treatment of Metastatic Epidural Spinal Cord Compression (MESCC)
May 19, 2015 updated by: AOSpine North America Research Network
Surgical Versus Nonoperative Treatment of Metastatic Epidural Spinal Cord Compression. Quality of Life and Cost-effectiveness Outcomes
The aim of this trial is to evaluate the differences in pain relief, neurological function, quality of life and survival in patients with metastatic epidural spinal cord compression (MESCC) who are managed with a combination of surgery and radiotherapy versus radiotherapy alone.
Further we shall evaluate cost-effectiveness of the two treatment approaches.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
163
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 4E3
- University of British Columbia
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Ontario
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Toronto, Ontario, Canada, M5T 2S8
- University of Toronto
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Toronto, Ontario, Canada, M4N 3M5
- Sunnybrook Health Sciences Center
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Kansas
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Kansas City, Kansas, United States, 66160-0001
- University of Kansas Medical Center
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Maryland
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Baltimore, Maryland, United States, 21287
- Johns Hopkins University
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Hospital of the University of Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107-4216
- Thomas Jefferson University and The Rothman Institute
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Texas
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Houston, Texas, United States, 77030
- University of Texas Hospital / MD Anderson Cancer Center
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West Virginia
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Morgantown, West Virginia, United States, 26506
- West Viginia University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients who present for the treatment of new (cohorts 1 & 3) or old (cohort 2) metastatic epidural spinal cord compression at the participating sites.
Description
Inclusion Criteria:
- Single symptomatic metastatic epidural spinal compression at any level confirmed by MRI
- Age 18 and more
- Able and willing to give written informed consent to participate in the study
- Able to read and write English on an elementary level
Exclusion Criteria:
- Multiple symptomatic spinal metastases
- Radiosensitive tumors
- Radioresistant tumors
- Primary cancer site in CNS or spine
- Poor life expectancy (< 3 months)
- Patients with a tumor that has compressed only the cauda equina or spinal roots
- Has a recent history of substance abuse
- Is a prisoner
- Currently involved in another study
- has a disease or condition that would preclude accurate evaluation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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1
De novo surgical cohort
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Surgical excision of the metastatic process
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2
Nonoperative treatment cohort
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Standard of care radiotherapy for patients with metastatic epidural spinal cord compression.
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3
Secondary surgical treatment cohort
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Surgical excision of the metastatic process
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in spine-associated pain intensity (BPI) measured by Brief Pain Inventory
Time Frame: 6 weeks / 3, 6, 9, 12, 18, 24 months
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6 weeks / 3, 6, 9, 12, 18, 24 months
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Neurological outcomes measured by American Spinal Injury Association (ASIA) Motor Scale structured clinical examination
Time Frame: 24 months
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24 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Adverse events
Time Frame: 24 months
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24 months
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Survival
Time Frame: 24 months
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24 months
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SF-36 v2
Time Frame: 24 month
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24 month
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EQ-5D
Time Frame: 24 months
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24 months
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Oswestry Disability Index (ODI)
Time Frame: 24 months
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24 months
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Caregiver Activity Survey
Time Frame: 24 months
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24 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Michael Fehlings, MD FRCSC, University of Toronto
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Sciubba DM, Petteys RJ, Dekutoski MB, Fisher CG, Fehlings MG, Ondra SL, Rhines LD, Gokaslan ZL. Diagnosis and management of metastatic spine disease. A review. J Neurosurg Spine. 2010 Jul;13(1):94-108. doi: 10.3171/2010.3.SPINE09202.
- Furlan JC, Chan KK, Sandoval GA, Lam KC, Klinger CA, Patchell RA, Laporte A, Fehlings MG. The combined use of surgery and radiotherapy to treat patients with epidural cord compression due to metastatic disease: a cost-utility analysis. Neuro Oncol. 2012 May;14(5):631-40. doi: 10.1093/neuonc/nos062. Epub 2012 Apr 14.
- Fitzpatrick D, Grabarz D, Wang L, Bezjak A, Fehlings MG, Fosker C, Rampersaud R, Wong RK. How effective is a virtual consultation process in facilitating multidisciplinary decision-making for malignant epidural spinal cord compression? Int J Radiat Oncol Biol Phys. 2012 Oct 1;84(2):e167-72. doi: 10.1016/j.ijrobp.2012.03.057. Epub 2012 Jun 8.
- Fisher CG, Schouten R, Versteeg AL, Boriani S, Varga PP, Rhines LD, Kawahara N, Fourney D, Weir L, Reynolds JJ, Sahgal A, Fehlings MG, Gokaslan ZL. Reliability of the Spinal Instability Neoplastic Score (SINS) among radiation oncologists: an assessment of instability secondary to spinal metastases. Radiat Oncol. 2014 Mar 4;9:69. doi: 10.1186/1748-717X-9-69.
- Fisher CG, Versteeg AL, Schouten R, Boriani S, Varga PP, Rhines LD, Heran MK, Kawahara N, Fourney D, Reynolds JJ, Fehlings MG, Gokaslan ZL. Reliability of the spinal instability neoplastic scale among radiologists: an assessment of instability secondary to spinal metastases. AJR Am J Roentgenol. 2014 Oct;203(4):869-74. doi: 10.2214/AJR.13.12269.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2008
Primary Completion (Actual)
March 1, 2013
Study Completion (Actual)
March 1, 2013
Study Registration Dates
First Submitted
March 3, 2008
First Submitted That Met QC Criteria
March 12, 2008
First Posted (Estimate)
March 13, 2008
Study Record Updates
Last Update Posted (Estimate)
May 21, 2015
Last Update Submitted That Met QC Criteria
May 19, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.