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Completed

NCT Number: NCT00634426

Surgical Versus Nonoperative Treatment of Metastatic Epidural Spinal Cord Compression

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.

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Key information

Conditions

Metastatic Epidural Spinal Cord Compression Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of British Columbia, Vancouver, British Columbia, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surgical excision of the metastatic process

Procedure

Surgical excision of the metastatic process

Radiotherapy of the metastatic spine process

Radiation

Standard of care radiotherapy for patients with metastatic epidural spinal cord compression.

Primary outcomes

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

    Time frame: 6 weeks / 3, 6, 9, 12, 18, 24 months

  2. Neurological outcomes measured by American Spinal Injury Association (ASIA) Motor Scale structured clinical examination

    Time frame: 24 months

Secondary outcomes

  1. Survival

    Time frame: 24 months

  2. SF-36 v2

    Time frame: 24 month

  3. EQ-5D

    Time frame: 24 months

  4. Oswestry Disability Index (ODI)

    Time frame: 24 months

  5. Caregiver Activity Survey

    Time frame: 24 months

  6. Adverse events

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

AOSpine North America Research Network

Network

Collaborators

  • AOSpine North America

Registry information

Official study title

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

Acronym: MESCC

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Mar 13, 2008
Registry last updated
May 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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