Surgical Versus Nonoperative Treatment of Metastatic Epidural Spinal Cord Compression
NCT ID: NCT00634426
Last Updated: 2015-05-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
163 participants
OBSERVATIONAL
2008-03-31
2013-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Further we shall evaluate cost-effectiveness of the two treatment approaches.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Risk Adapted Spinal Cord/Cauda Constraint Relaxation for High-risk Patients With Metastatic Epidural Spinal Cord Compression Undergoing Spine Stereotactic Radiosurgery
NCT06204315
Cement Augmentation in Preventing Vertebral Body Compression Fracture Following Spine Stereotactic Radiosurgery in Patients With Solid Tumors and Spinal Metastases
NCT02387905
Single Session Spine Stereotactic Radiosurgery in Metastatic Epidural Spinal Cord Compression
NCT01256554
Phase I Study of Feasibility of Single Session Spine Stereotactic Radiosurgery (SSRS) in the Primary Management in Patients With Inoperable, Previously Unirradiated Metastatic Epidural Spinal Cord Compression (MESCC)
NCT01254903
Laser Interstitial Thermal Ablation and Stereotactic Radiosurgery for Patients With Spine Metastases
NCT05023772
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
De novo surgical cohort
Surgical excision of the metastatic process
Surgical excision of the metastatic process
2
Nonoperative treatment cohort
Radiotherapy of the metastatic spine process
Standard of care radiotherapy for patients with metastatic epidural spinal cord compression.
3
Secondary surgical treatment cohort
Surgical excision of the metastatic process
Surgical excision of the metastatic process
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Surgical excision of the metastatic process
Surgical excision of the metastatic process
Radiotherapy of the metastatic spine process
Standard of care radiotherapy for patients with metastatic epidural spinal cord compression.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AOSpine North America
INDUSTRY
AOSpine North America Research Network
NETWORK
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Michael Fehlings, MD FRCSC
Role: PRINCIPAL_INVESTIGATOR
University of Toronto
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Kansas Medical Center
Kansas City, Kansas, United States
Johns Hopkins University
Baltimore, Maryland, United States
Mayo Clinic
Rochester, Minnesota, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Thomas Jefferson University and The Rothman Institute
Philadelphia, Pennsylvania, United States
University of Texas Hospital / MD Anderson Cancer Center
Houston, Texas, United States
West Viginia University
Morgantown, West Virginia, United States
University of British Columbia
Vancouver, British Columbia, Canada
Sunnybrook Health Sciences Center
Toronto, Ontario, Canada
University of Toronto
Toronto, Ontario, Canada
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1011
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.