Stereotactic body radiotherapy versus conventional external beam radiotherapy in patients with painful spinal metastases: an open-label, multicentre, randomised, controlled, phase 2/3 trial

Mené au Canada et en Australie sur 229 patients adultes présentant des métastases vertébrales douloureuses (durée médiane de suivi : 6,7 mois), cet essai randomisé de phase II/III évalue l'efficacité, du point de vue de la réduction de la douleur, et la toxicité d'une radiothérapie corporelle stéréotaxique par rapport à une radiothérapie externe conventionnelle

Résumé en anglais

Background : Conventional external beam radiotherapy is the standard palliative treatment for spinal metastases; however, complete response rates for pain are as low as 10–20%. Stereotactic body radiotherapy delivers high-dose, ablative radiotherapy. We aimed to compare complete response rates for pain after stereotactic body radiotherapy or conventional external beam radiotherapy in patients with painful spinal metastasis.

Methods : This open-label, multicentre, randomised, controlled, phase 2/3 trial was done at 13 hospitals in Canada and five hospitals in Australia. Patients were eligible if they were aged 18 years and older, and had painful (defined as