Direct decompressive surgical resection in the treatment of spinal cord compression caused by metastatic cancer: a randomised trial
- Study type
- Clinical trial
- Design
- Randomised, multicentre, unblinded trial; stopped early after an interim analysis according to a prespecified stopping rule
- Sample size
- 101 patients (50 surgery followed by radiotherapy, 51 radiotherapy alone)
- Source
- Lancet · 2005
In plain words
When cancer reaches the spine and presses on the spinal cord, a person may lose the ability to walk. In this study, patients who first had surgery to take the pressure off the spinal cord and then had radiotherapy were much more often able to walk, and for much longer, than patients who had radiotherapy alone. Surgery is not suitable for everyone, and the treatment team decides based on each patient's situation.
Key results
Treatment arms and regimens
Direct decompressive surgical resection followed by radiotherapy 30 Gy in 10 fractions of 3 Gy.
Radiotherapy 30 Gy in 10 fractions of 3 Gy.
Details of corticosteroid administration and surgical technique in the full text of the paper.
Source of the regimen details: Abstract of the paper (radiotherapy 10 fractions of 3 Gy in both groups); details of corticosteroids and surgery in the full text of the paper
Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.
Study population
Patients with spinal cord compression caused by metastatic cancer; 123 patients were assessed for eligibility and 101 were randomised. 32 patients were unable to walk at entry. Detailed inclusion and exclusion criteria are in the full text of the paper.
Endpoints
Primary endpoint: ability to walk.
Secondary endpoints: urinary continence, muscle strength and functional status, need for corticosteroids and opioid analgesics, and length of survival. All analyses were by intention to treat.
Safety and side effects
The abstract does not report surgical complication data; safety details are in the full text of the paper.
Clinical significance and place in guidelines
This trial is the main evidence for the superiority of decompressive surgery followed by radiotherapy over radiotherapy alone in selected patients with metastatic spinal cord compression. The NICE guideline (NG234, 2023) recommends that surgery aimed at stopping or reversing neurological decline be done as soon as possible after the onset of neurological symptoms in suitable patients, with the decision made by a multidisciplinary team.
Limitations
Small sample size (101 patients) and early stopping after an interim analysis (which can overstate the effect size); no blinding; patients were selected by specific criteria (details in the full text) and the results should not be extended to all patients with spinal cord compression.
This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.