Metastatic Epidural Spinal Cord CompressionMESCCNCT00634426
Surgical Versus Nonoperative Treatment of Metastatic Epidural Spinal Cord Compression
An observational study of Metastatic Epidural Spinal Cord Compression, run by AOSpine North America Research Network at 10 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Epidural Spinal Cord Compression
- What is being tested?
- Surgical excision of the metastatic process and Radiotherapy of the metastatic spine process
- Type of treatment
- Surgery or procedure
- How many people
- 163 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Mar 2008to Mar 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States7 sites
Johns Hopkins University
Baltimore, Maryland, 21287
University of Texas Hospital / MD Anderson Cancer Center
Houston, Texas, 77030
University of Kansas Medical Center
Kansas City, Kansas, 66160-0001
West Viginia University
Morgantown, West Virginia, 26506
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Thomas Jefferson University and The Rothman Institute
Philadelphia, Pennsylvania, 19107-4216
Mayo Clinic
Rochester, Minnesota, 55905
Canada3 sites
Sunnybrook Health Sciences Center
Toronto, Ontario, M4N 3M5
University of Toronto
Toronto, Ontario, M5T 2S8
University of British Columbia
Vancouver, British Columbia, V5Z 4E3
About this study
Official title: 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.
- Being tested
- Surgical excision of the metastatic process, Radiotherapy of the metastatic spine process
- Keywords
- Spine, Neoplasm metastasis, Treatment, surgical, Treatment, nonoperative, Quality of life
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical excision of the metastatic processProcedure or surgery
Surgical excision of the metastatic process
Radiotherapy of the metastatic spine processRadiation
Standard of care radiotherapy for patients with metastatic epidural spinal cord compression.
| Study group | Role | What they receive |
|---|---|---|
| 1 | De novo surgical cohort Receives: Procedure: Surgical excision of the metastatic process | |
| 2 | Nonoperative treatment cohort Receives: Radiation: Radiotherapy of the metastatic spine process | |
| 3 | Secondary surgical treatment cohort Receives: Procedure: Surgical excision of the metastatic process |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in spine-associated pain intensity (BPI) measured by Brief Pain Inventory
Measured: 6 weeks / 3, 6, 9, 12, 18, 24 months
Neurological outcomes measured by American Spinal Injury Association (ASIA) Motor Scale structured clinical examination
Measured: 24 months
Secondary outcomes (6)
Survival
Measured: 24 months
SF-36 v2
Measured: 24 month
EQ-5D
Measured: 24 months
Oswestry Disability Index (ODI)
Measured: 24 months
Caregiver Activity Survey
Measured: 24 months
Adverse events
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Metastatic Epidural Spinal Cord CompressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- AOSpine North America Research Network
- Sponsor type
- Research network
- Collaborators
- AOSpine North America
- Responsible party
- Sponsor
- Investigators
- Michael Fehlings, MD FRCSC, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00634426
- Sponsor's protocol ID
- 1011
- Acronym
- MESCC
- Status last verified
- Mar 2015
- First submitted
- 3 Mar 2008
- Last updated
- 21 May 2015
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 20594024Furlan 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.
PubMed 22505658Fitzpatrick 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.
PubMed 22682804Fisher 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.
PubMed 24594004Fisher 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.
PubMed 25247954
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Versus Nonoperative Treatment of Metastatic Epidural Spinal Cord Compression. Quality of Life and Cost-effectiveness Outcomes
- ClinicalTrials.gov ID
- NCT00634426
- Acronym / sponsor ID
- MESCC / 1011
- Keywords
- Spine, Neoplasm metastasis, Treatment, surgical, Treatment, nonoperative, Quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- AOSpine North America Research NetworkResearch network
- Collaborators
- AOSpine North America
- Study start
- Mar 2008
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 13 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: Surgical excision of the metastatic processDe novo surgical cohort |
| 2 | – | Radiation: Radiotherapy of the metastatic spine processNonoperative treatment cohort |
| 3 | – | Procedure: Surgical excision of the metastatic processSecondary surgical treatment cohort |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- Multiple symptomatic spinal metastases
- Radiosensitive tumors
- Radioresistant tumors
- Primary cancer site in CNS or spine
- Poor life expectancy (< 3 months)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical excision of the metastatic processSurgical excision of the metastatic process | Procedure or surgery | 1, 3 |
| Radiotherapy of the metastatic spine processStandard of care radiotherapy for patients with metastatic epidural spinal cord compression. | Radiation | 2 |
Primary outcome
Change in spine-associated pain intensity (BPI) measured by Brief Pain Inventory
Time frame: 6 weeks / 3, 6, 9, 12, 18, 24 months
Neurological outcomes measured by American Spinal Injury Association (ASIA) Motor Scale structured clinical examination
Time frame: 24 months
6 secondary outcomes
Survival
Time frame: 24 months
SF-36 v2
Time frame: 24 month
EQ-5D
Time frame: 24 months
Oswestry Disability Index (ODI)
Time frame: 24 months
Caregiver Activity Survey
Time frame: 24 months
Adverse events
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2015.
- Background: PubMed 20594024Sciubba 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.
- Background: PubMed 22505658Furlan 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.
- Results publication: PubMed 22682804Fitzpatrick 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.
- Results publication: PubMed 24594004Fisher 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.
- Results publication: PubMed 25247954Fisher 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Fehlings, MD FRCSC principal investigator
University of Toronto
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Epidural Spinal Cord Compression, run by AOSpine North America Research Network at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in spine-associated pain intensity (BPI) measured by Brief Pain Inventory (time frame: 6 weeks / 3, 6, 9, 12, 18, 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00634426, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2015.