TY - JOUR AV - public SN - 1468-6694 Y1 - 2015/// TI - High-dose single-fraction IMRT versus fractionated external beam radiotherapy for patients with spinal bone metastases: study protocol for a randomized controlled trial JF - Trials ID - heidok19405 VL - 16 SP - 1 N2 - 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). PB - BioMed Central EP - 5 CY - London IS - 264 UR - https://archiv.ub.uni-heidelberg.de/volltextserver/19405/ A1 - Rief, Harald A1 - Katayama, Sonja A1 - Bruckner, Thomas A1 - Rieken, Stefan A1 - Bostel, Tilman A1 - Förster, Robert A1 - Schlampp, Ingmar A1 - Wolf, Robert A1 - Debus, Jürgen A1 - Sterzing, Florian ER -