Non-inferiority randomised phase 3 trial comparing two radiation schedules (single vs. five fractions) in malignant spinal cord compression

Pierre G Thirion, Mary T Dunne, Paul J Kelly, Aileen Flavin, Joe M O'Sullivan, Dayle Hacking, Wojciech Sasiadek, Cormac Small, Maeve M Pomeroy, Joseph Martin, Orla McArdle, Imelda Parker, Lydia S O'Sullivan, Aoife M Shannon, Angela Clayton-Lea, Conor D Collins, Michael R Stevenson, Alberto Alvarez-Iglesias, John G Armstrong, Michael Moriarty

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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.

Original languageEnglish
JournalBritish Journal of Cancer
Early online date11 Mar 2020
DOIs
Publication statusEarly online date - 11 Mar 2020
Externally publishedYes

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    Thirion, P. G., Dunne, M. T., Kelly, P. J., Flavin, A., O'Sullivan, J. M., Hacking, D., Sasiadek, W., Small, C., Pomeroy, M. M., Martin, J., McArdle, O., Parker, I., O'Sullivan, L. S., Shannon, A. M., Clayton-Lea, A., Collins, C. D., Stevenson, M. R., Alvarez-Iglesias, A., Armstrong, J. G., & Moriarty, M. (2020). Non-inferiority randomised phase 3 trial comparing two radiation schedules (single vs. five fractions) in malignant spinal cord compression. British Journal of Cancer. https://doi.org/10.1038/s41416-020-0768-z