Surgical Versus Nonoperative Treatment of Metastatic Epidural Spinal Cord Compression

Completed

• Conditions: Metastatic Epidural Spinal Cord Compression
• Interventions: Radiation: Radiotherapy of the metastatic spine process; Procedure: Surgical excision of the metastatic process

• 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

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-03-03
• Study First Submitted QC: 2008-03-12
• Study First Posted: 2008-03-13
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2015-03
• Last Update Submitted: 2015-05-19
• Last Update Posted: 2015-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 163

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
2	Radiotherapy of the metastatic spine process	Nonoperative treatment cohort
3	Surgical excision of the metastatic process	Secondary surgical treatment cohort
1	Surgical excision of the metastatic process	De novo surgical cohort

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 British Columbia; 🇨🇦 Vancouver, British Columbia, Canada

Thomas Jefferson University and The Rothman Institute; 🇺🇸 Philadelphia, Pennsylvania, United States

West Viginia University; 🇺🇸 Morgantown, West Virginia, United States

Sunnybrook Health Sciences Center; 🇨🇦 Toronto, Ontario, Canada

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Texas Hospital / MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

University of Toronto; 🇨🇦 Toronto, Ontario, Canada

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States