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Surgical Versus Nonoperative Treatment of Metastatic Epidural Spinal Cord Compression (MESCC)

This study has been completed.
Sponsor:
Collaborator:
AOSpine North America
Information provided by (Responsible Party):
AOSpine North America Research Network
ClinicalTrials.gov Identifier:
NCT00634426
First received: March 3, 2008
Last updated: May 19, 2015
Last verified: March 2015
  Purpose

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.


Condition Intervention Phase
Metastatic Epidural Spinal Cord Compression
Procedure: Surgical excision of the metastatic process
Radiation: Radiotherapy of the metastatic spine process
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Surgical Versus Nonoperative Treatment of Metastatic Epidural Spinal Cord Compression. Quality of Life and Cost-effectiveness Outcomes

Further study details as provided by AOSpine North America Research Network:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 163
Study Start Date: March 2008
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
De novo surgical cohort
Procedure: Surgical excision of the metastatic process
Surgical excision of the metastatic process
2
Nonoperative treatment cohort
Radiation: Radiotherapy of the metastatic spine process
Standard of care radiotherapy for patients with metastatic epidural spinal cord compression.
3
Secondary surgical treatment cohort
Procedure: Surgical excision of the metastatic process
Surgical excision of the metastatic process

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00634426

Locations
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160-0001
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Thomas Jefferson University and The Rothman Institute
Philadelphia, Pennsylvania, United States, 19107-4216
United States, Texas
University of Texas Hospital / MD Anderson Cancer Center
Houston, Texas, United States, 77030
United States, West Virginia
West Viginia University
Morgantown, West Virginia, United States, 26506
Canada, British Columbia
University of British Columbia
Vancouver, British Columbia, Canada, V5Z 4E3
Canada, Ontario
Sunnybrook Health Sciences Center
Toronto, Ontario, Canada, M4N 3M5
University of Toronto
Toronto, Ontario, Canada, M5T 2S8
Sponsors and Collaborators
AOSpine North America Research Network
AOSpine North America
Investigators
Principal Investigator: Michael Fehlings, MD FRCSC University of Toronto
  More Information

Publications:

Responsible Party: AOSpine North America Research Network
ClinicalTrials.gov Identifier: NCT00634426     History of Changes
Other Study ID Numbers: 1011
Study First Received: March 3, 2008
Last Updated: May 19, 2015

Keywords provided by AOSpine North America Research Network:
Spine
Neoplasm metastasis
Treatment, surgical
Treatment, nonoperative
Quality of life

Additional relevant MeSH terms:
Spinal Cord Compression
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on April 28, 2017