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Surgical Versus Nonoperative Treatment of Metastatic Epidural Spinal Cord Compression. Quality of Life and Cost-effectiveness Outcomes


Phase 4
18 Years
N/A
Not Enrolling
Both
Metastatic Epidural Spinal Cord Compression

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Trial Information

Surgical Versus Nonoperative Treatment of Metastatic Epidural Spinal Cord Compression. Quality of Life and Cost-effectiveness Outcomes


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Change in spine-associated pain intensity (BPI) measured by Brief Pain Inventory

Outcome Time Frame:

6 weeks / 3, 6, 9, 12, 18, 24 months

Safety Issue:

No

Principal Investigator

Michael Fehlings, MD FRCSC

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Toronto

Authority:

United States: Institutional Review Board

Study ID:

1011

NCT ID:

NCT00634426

Start Date:

March 2008

Completion Date:

March 2013

Related Keywords:

  • Metastatic Epidural Spinal Cord Compression
  • Spine
  • Neoplasm metastasis
  • Treatment, surgical
  • Treatment, nonoperative
  • Quality of life
  • Spinal Cord Compression

Name

Location

Johns Hopkins UniversityBaltimore, Maryland  21205
Mayo ClinicRochester, Minnesota  55905
University of Kansas Medical CenterKansas City, Kansas  66160-7353
Hospital of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104
Thomas Jefferson University and The Rothman InstitutePhiladelphia, Pennsylvania  19107-4216
University of Texas Hospital / MD Anderson Cancer CenterHouston, Texas  77030
West Viginia UniversityMorgantown, West Virginia  26506