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- Title
Non-inferiority randomised phase 3 trial comparing two radiation schedules (single vs. five fractions) in malignant spinal cord compression.
- Authors
Thirion, Pierre G.; Dunne, Mary T.; Kelly, Paul J.; Flavin, Aileen; O'Sullivan, Joe M.; Hacking, Dayle; Sasiadek, Wojciech; Small, Cormac; Pomeroy, Maeve M.; Martin, Joseph; McArdle, Orla; Parker, Imelda; O'Sullivan, Lydia S.; Shannon, Aoife M.; Clayton-Lea, Angela; Collins, Conor D.; Stevenson, Michael R.; Alvarez-Iglesias, Alberto; Armstrong, John G.; Moriarty, Michael
- Abstract
<bold>Background: </bold>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.<bold>Methods: </bold>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.<bold>Results: </bold>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).<bold>Conclusion: </bold>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.<bold>Clinical Trial Registration: </bold>Cancer Trials Ireland ICORG 05-03; NCT00968643; EU-20952.
- Subjects
IRELAND; SPINAL cord tumors; TREATMENT effectiveness; RANDOMIZED controlled trials; RADIOTHERAPY; STATISTICAL sampling; SPINAL cord compression
- Publication
British Journal of Cancer, 2020, Vol 122, Issue 9, p1315
- ISSN
0007-0920
- Publication type
journal article
- DOI
10.1038/s41416-020-0768-z