CompletedNot Applicable

Surgical Versus Nonoperative Treatment of Metastatic Epidural Spinal Cord Compression

United States163 participantsStarted 2008-03

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change in spine-associated pain intensity (BPI) measured by Brief Pain Inventory

Timeframe: 6 weeks / 3, 6, 9, 12, 18, 24 months

Neurological outcomes measured by American Spinal Injury Association (ASIA) Motor Scale structured clinical examination

Timeframe: 24 months

Trial details

NCT IDNCT00634426

SponsorAOSpine North America Research Network

Sponsor typeNETWORK

Study typeOBSERVATIONAL

Primary completion2013-03

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