Skip to content

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00634426
Acronym
MESCC
Enrollment
163
Registered
2008-03-13
Start date
2008-03-31
Completion date
2013-03-31
Last updated
2015-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Epidural Spinal Cord Compression

Keywords

Spine, Neoplasm metastasis, Treatment, surgical, Treatment, nonoperative, Quality of life

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.

Interventions

PROCEDURESurgical excision of the metastatic process

Surgical excision of the metastatic process

RADIATIONRadiotherapy of the metastatic spine process

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

Sponsors

AOSpine North America
CollaboratorINDUSTRY
AOSpine North America Research Network
Lead SponsorNETWORK

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Change in spine-associated pain intensity (BPI) measured by Brief Pain Inventory6 weeks / 3, 6, 9, 12, 18, 24 months
Neurological outcomes measured by American Spinal Injury Association (ASIA) Motor Scale structured clinical examination24 months

Secondary

MeasureTime frame
EQ-5D24 months
Oswestry Disability Index (ODI)24 months
Survival24 months
Adverse events24 months
Caregiver Activity Survey24 months
SF-36 v224 month

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026