Surgical Versus Nonoperative Treatment of Metastatic Epidural Spinal Cord Compression

Study Overview
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Brief Summary
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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.

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

Conditions
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Metastatic Epidural Spinal Cord Compression

Intervention / Treatment
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* Procedure: Surgical excision of the metastatic process
* Radiation: Radiotherapy of the metastatic spine process


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>De novo surgical cohort | Procedure: Surgical excision of the metastatic process<br>* Surgical excision of the metastatic process<br>|
| 2<br>Nonoperative treatment cohort | Radiation: Radiotherapy of the metastatic spine process<br>* Standard of care radiotherapy for patients with metastatic epidural spinal cord compression.<br>|
| 3<br>Secondary surgical treatment cohort | Procedure: Surgical excision of the metastatic process<br>* Surgical excision of the metastatic process<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spine, Neoplasm metastasis, Treatment, surgical, Treatment, nonoperative, Quality of life