Surgical Versus Nonoperative Treatment of Metastatic Epidural Spinal Cord Compression
- Conditions
- Metastatic Epidural Spinal Cord Compression
- Registration Number
- NCT00634426
- Lead Sponsor
- AOSpine North America Research Network
- Brief 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.
Further we shall evaluate cost-effectiveness of the two treatment approaches.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 163
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in spine-associated pain intensity (BPI) measured by Brief Pain Inventory 6 weeks / 3, 6, 9, 12, 18, 24 months Neurological outcomes measured by American Spinal Injury Association (ASIA) Motor Scale structured clinical examination 24 months
- Secondary Outcome Measures
Name Time Method Survival 24 months SF-36 v2 24 month EQ-5D 24 months Oswestry Disability Index (ODI) 24 months Caregiver Activity Survey 24 months Adverse events 24 months
Trial Locations
- Locations (10)
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
University of Kansas Medical Center🇺🇸Kansas City, Kansas, United States