In: Trials, 16 (2015), Nr. 264. pp. 1-5. ISSN 1468-6694

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PDF, English Download (497kB) | Lizenz: High-dose single-fraction IMRT versus fractionated external beam radiotherapy for patients with spinal bone metastases: study protocol for a randomized controlled trial by Rief, Harald ; Katayama, Sonja ; Bruckner, Thomas ; Rieken, Stefan ; Bostel, Tilman ; Förster, Robert ; Schlampp, Ingmar ; Wolf, Robert ; Debus, Jürgen ; Sterzing, Florian underlies the terms of Creative Commons Attribution 3.0 Germany

Abstract

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).