Clinical trialBreast cancerLung cancerProstate cancer

Effect of Single-Fraction vs Multifraction Radiotherapy on Ambulatory Status Among Patients With Spinal Canal Compression From Metastatic Cancer: The SCORAD Randomized Clinical Trial

JAMA · 2019686 patients (345 single-fraction radiotherapy, 341 5-fraction radiotherapy)
Hoskin PJ, Hopkins K, Misra V, et al. JAMA. 2019. 322:2084-2094
Study type
Clinical trial
Study name
SCORAD
Design
Randomised multicentre non-inferiority trial at 42 radiotherapy centres in the UK and 5 in Australia; ISRCTN97555949 and ISRCTN97108008
Sample size
686 patients (345 single-fraction radiotherapy, 341 5-fraction radiotherapy)
Source
JAMA · 2019

In plain words

When cancer presses on the spinal cord, radiotherapy is usually given. This study looked at whether one radiotherapy session helps keep people walking as well as 5 sessions. The results of the two approaches were very close (about 7 in 10 people were walking after 8 weeks), but statistically it cannot be said with certainty that one session is "just as good". For many patients, especially those with a short life expectancy, one radiotherapy session means fewer trips to hospital.

Key results

69.3% vs 72.7%
Ambulatory (grade 1 or 2) at week 8 — primary outcome
115 of 166 vs 128 of 176; difference -3.5% (one-sided 95% CI -11.5% to ∞); P for non-inferiority = 0.06 (non-inferiority not shown)
63.9% vs 64.3%
Ambulatory at week 1
Difference -0.4% (lower limit -6.9); P for non-inferiority = 0.004
66.8% vs 67.6%
Ambulatory at week 4
Difference -0.7% (lower limit -8.1); P for non-inferiority = 0.01
71.8% vs 67.7%
Ambulatory at week 12
Difference 4.1% (lower limit -4.6); P for non-inferiority = 0.002
50% vs 55%
12-week overall survival
Stratified HR 1.02 (95% CI 0.74 to 1.41)

Treatment arms and regimens

1Single-fraction radiotherapy

External beam radiotherapy 8 Gy in one fraction.

2Multifraction radiotherapy

Radiotherapy 20 Gy in 5 fractions on 5 consecutive days.

Source of the regimen details: Abstract of the paper (JAMA 2019; PMC6902166)

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 metastatic cancer and spinal cord or cauda equina compression, life expectancy over 8 weeks and no prior radiotherapy to the same area; enrolled from February 2008 to April 2016. Median age 70 years, 73% men; 44% prostate cancer, 19% lung cancer and 12% breast cancer.

Endpoints

Primary outcome: ambulatory status at week 8 on a 4-point scale; grade 1 (walking without aids and muscle power 5 of 5) or grade 2 (walking with aids or muscle power 4 of 5). The non-inferiority margin for the difference in ambulatory status was -11%.

Secondary outcomes: ambulatory status at weeks 1, 4 and 12, and overall survival.

Safety and side effects

The abstract does not report adverse event data separately; of the 11 other secondary outcomes analysed, differences were either not significant or did not meet the non-inferiority criterion. Details in the full text.

Clinical significance and place in guidelines

SCORAD is the largest trial comparing single-fraction and multifraction radiotherapy in metastatic spinal cord compression. The NICE guideline (NG234, 2023) recommends 8 Gy in a single fraction for patients with MSCC receiving radiotherapy, unless the risk of toxicity is high (large treatment field or prior radiotherapy), in which case multifraction radiotherapy is considered.

Limitations

255 patients died before the week-8 assessment and only 342 (49.8%) were included in the primary outcome analysis; the lower confidence limit (-11.5%) only slightly exceeded the non-inferiority margin (-11%); the population was mostly solid tumours (especially prostate).

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.