title: High-dose single-fraction IMRT versus fractionated external beam radiotherapy for patients with spinal bone metastases: study protocol for a randomized controlled trial creator: Rief, Harald creator: Katayama, Sonja creator: Bruckner, Thomas creator: Rieken, Stefan creator: Bostel, Tilman creator: Förster, Robert creator: Schlampp, Ingmar creator: Wolf, Robert creator: Debus, Jürgen creator: Sterzing, Florian subject: ddc-610 subject: 610 Medical sciences Medicine description: 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). publisher: BioMed Central date: 2015 type: Article type: info:eu-repo/semantics/article type: NonPeerReviewed format: application/pdf identifier: https://archiv.ub.uni-heidelberg.de/volltextserverhttps://archiv.ub.uni-heidelberg.de/volltextserver/19405/1/13063_2015_Article_761.pdf identifier: DOI: identifier: urn:nbn:de:bsz:16-heidok-194053 identifier: Rief, Harald ; Katayama, Sonja ; Bruckner, Thomas ; Rieken, Stefan ; Bostel, Tilman ; Förster, Robert ; Schlampp, Ingmar ; Wolf, Robert ; Debus, Jürgen ; Sterzing, Florian (2015) High-dose single-fraction IMRT versus fractionated external beam radiotherapy for patients with spinal bone metastases: study protocol for a randomized controlled trial. Trials, 16 (264). pp. 1-5. ISSN 1468-6694 relation: https://archiv.ub.uni-heidelberg.de/volltextserver/19405/ rights: info:eu-repo/semantics/openAccess rights: Please see front page of the work (Sorry, Dublin Core plugin does not recognise license id) language: eng