1. Non-inferiority randomised phase 3 trial comparing two radiation schedules (single vs. five fractions) in malignant spinal cord compression.
- Author
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Thirion PG, Dunne MT, Kelly PJ, Flavin A, O'Sullivan JM, Hacking D, Sasiadek W, Small C, Pomeroy MM, Martin J, McArdle O, Parker I, O'Sullivan LS, Shannon AM, Clayton-Lea A, Collins CD, Stevenson MR, Alvarez-Iglesias A, Armstrong JG, and Moriarty M
- Subjects
- Adult, Aged, Aged, 80 and over, Female, Humans, Ireland epidemiology, Male, Middle Aged, Radiotherapy adverse effects, Risk Factors, Spinal Cord Compression pathology, Spinal Cord Neoplasms pathology, Treatment Outcome, Dose Fractionation, Radiation, Spinal Cord Compression radiotherapy, Spinal Cord Neoplasms radiotherapy
- Abstract
Background: The optimal EBRT schedule for MSCC is undetermined. Our aim was to determine whether a single fraction (SF) was non-inferior to five daily fractions (5Fx), for functional motor outcome., Methods: Patients not proceeding with surgical decompression in this multicentre non-inferiority, Phase 3 trial were randomised to 10 Gy/SF or 20 Gy/5Fx. A change in mobility from baseline to 5 weeks for each patient, was evaluated by a Modified Tomita score: 1 = 'Walk unaided', 2 = 'With walking aid' and 3 = 'Bed-bound'. The margin used to establish non-inferiority was a detrimental change of -0.4 in the mean difference between arms., Results: One-hundred and twelve eligible patients were enrolled. Seventy-three patients aged 30-87 were evaluated for the primary analysis. The 95% CI for the difference in the mean change in mobility scores between arms was -0.12 to 0.6. Since -0.4 is not included in the interval, there is evidence that 10 Gy/SF is non-inferior to 20 Gy/5Fx. One grade 3 AE was reported in the 5Fx arm. Twelve (26%) patients in the 5Fx arm had a Grade 2-3 AE compared with six (11%) patients in the SF arm (p = 0.093)., Conclusion: For mobility preservation, one 10-Gy fraction is non-inferior to 20 Gy in five fractions, in patients with MSCC not proceeding with surgical decompression., Clinical Trial Registration: Cancer Trials Ireland ICORG 05-03; NCT00968643; EU-20952.
- Published
- 2020
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