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

AOSpine North America Research Network

Status: Completed

Conditions: Metastatic Epidural Spinal Cord Compression

Treatments: Radiation: Radiotherapy of the metastatic spine process; Procedure: Surgical excision of the metastatic process

Study type: Observational

Funder types: NETWORK; Industry

Identifiers

NCT00634426

1011

Details and patient eligibility

About

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.

Enrollment: 163 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

163 participants in 3 patient groups

1

Description:

De novo surgical cohort

Treatment:

Procedure: Surgical excision of the metastatic process

2

Description:

Nonoperative treatment cohort

Treatment:

Radiation: Radiotherapy of the metastatic spine process

3

Description:

Secondary surgical treatment cohort

Treatment:

Procedure: Surgical excision of the metastatic process