%0 Journal Article
%@ 1468-6694
%A Rief, Harald
%A Katayama, Sonja
%A Bruckner, Thomas
%A Rieken, Stefan
%A Bostel, Tilman
%A Förster, Robert
%A Schlampp, Ingmar
%A Wolf, Robert
%A Debus, Jürgen
%A Sterzing, Florian
%C London
%D 2015
%F heidok:19405
%I BioMed Central
%J Trials
%N 264
%P 1-5
%T High-dose single-fraction IMRT versus fractionated external beam radiotherapy for patients with spinal bone metastases: study protocol for a randomized controlled trial
%U https://archiv.ub.uni-heidelberg.de/volltextserver/19405/
%V 16
%X Background: Stereotactic body radiation therapy (SBRT)using intensity-modulated radiotherapy (IMRT) can be a safe modality for treating spinal bone metastasis with enhanced targeting accuracy and an effective method for achieving good tumor control and a rigorous pain response.   Methods/design: This is a single-center, prospective randomized controlled trial to evaluate pain relief after RT and consists of two treatment groups with 30 patients in each group. One group will receive single-fraction intensity-modulated RT with 1×24 Gy, and the other will receive fractionated RT with 10×3 Gy. The target parameters will be measured at baseline and at 3 and 6 months after RT.   Discussion: The aim of this study is to evaluate pain relief after RT in patients with spinal bone metastases by means of two different techniques: stereotactic body radiation therapy and fractionated RT. The primary endpoint is pain relief at the 3-month time-point after RT. Secondly, quality of life, fatigue, overall and bone survival, and local control will be assessed.   Trial registration ClinicalTrials.gov identifier NCT02358720  (June 2, 2015).