Surgical Versus Nonoperative Treatment of Metastatic Epidural Spinal Cord Compression

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

NCT00634426•AOSpine North America Research Network

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

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

Key Dates

Start Date

March 1, 2008

Primary Completion Date

March 1, 2013

Completion Date

March 1, 2013

Last Updated

May 21, 2015

Enrollment

163

ACTUAL participants

Conditions

Metastatic Epidural Spinal Cord Compression

Interventions

Surgical excision of the metastatic process

PROCEDURE

Radiotherapy of the metastatic spine process

RADIATION