CompletedNot Applicable

Surgical Versus Nonoperative Treatment of Metastatic Epidural Spinal Cord Compression

United States, Canada163 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 range

18 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Metastatic Epidural Spinal Cord Compression trials