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Non-inferiority randomised phase 3 trial comparing two radiation schedules (single vs. five fractions) in malignant spinal cord compression.
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.
Afiliación
  • Thirion PG; Cancer Trials Ireland (formerly All-Ireland Cooperative Oncology Research Group (ICORG)) and St Luke's Radiation Oncology Network (SLRON), Dublin, Ireland.
  • Dunne MT; SLRON, Dublin, Ireland. mary.dunne@slh.ie.
  • Kelly PJ; Cork University Hospital, Cork, Ireland.
  • Flavin A; Cork University Hospital, Cork, Ireland.
  • O'Sullivan JM; Belfast City Hospital, Dublin, Ireland.
  • Hacking D; UPMC Whitfield Cancer Centre, Waterford, Ireland.
  • Sasiadek W; University of Pittsburgh Medical Center, Whitfield Cancer Centre, Waterford, Ireland.
  • Small C; Galway University Hospital, Galway, Ireland.
  • Pomeroy MM; Galway University Hospital, Galway, Ireland.
  • Martin J; Galway University Hospital, Galway, Ireland.
  • McArdle O; SLRON, Dublin, Ireland.
  • Parker I; Cancer Trials Ireland, Dublin, Ireland.
  • O'Sullivan LS; SLRON, Dublin, Ireland.
  • Shannon AM; Cancer Trials Ireland, Dublin, Ireland.
  • Clayton-Lea A; SLRON, Dublin, Ireland.
  • Collins CD; SLRON, Dublin, Ireland.
  • Stevenson MR; Statistics and Data Management Office for ICORG, Clinical Research Support Centre, Belfast, Ireland.
  • Alvarez-Iglesias A; The HRB Clinical Research Facility, Galway, Ireland.
  • Armstrong JG; SLRON, Dublin, Ireland.
  • Moriarty M; SLRON, Dublin, Ireland.
Br J Cancer ; 122(9): 1315-1323, 2020 04.
Article en En | MEDLINE | ID: mdl-32157242
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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Compresión de la Médula Espinal / Neoplasias de la Médula Espinal / Fraccionamiento de la Dosis de Radiación Tipo de estudio: Clinical_trials / Etiology_studies / Risk_factors_studies Límite: Adult / Aged / Aged80 / Female / Humans / Male / Middle aged País/Región como asunto: Europa Idioma: En Revista: Br J Cancer Año: 2020 Tipo del documento: Article País de afiliación: Irlanda Pais de publicación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Compresión de la Médula Espinal / Neoplasias de la Médula Espinal / Fraccionamiento de la Dosis de Radiación Tipo de estudio: Clinical_trials / Etiology_studies / Risk_factors_studies Límite: Adult / Aged / Aged80 / Female / Humans / Male / Middle aged País/Región como asunto: Europa Idioma: En Revista: Br J Cancer Año: 2020 Tipo del documento: Article País de afiliación: Irlanda Pais de publicación: Reino Unido