title: High-dose single-fraction IMRT versus fractionated external beam radiotherapy for patients with spinal bone metastases: study protocol for a randomized controlled trial.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov identifier NCT02358720 (June 2, 2015).
authors.affiliation: Department of Radiation Oncology, University Hospital of Heidelberg, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany. harald.rief@med.uni-heidelberg.de.
authors.forename: Harald
authors.initials: H
authors.lastname: Rief
authors.affiliation: Department of Radiation Oncology, University Hospital of Heidelberg, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany. sonja.katayama@med.uni-heidelberg.de.
authors.forename: Sonja
authors.initials: S
authors.lastname: Katayama
authors.affiliation: Department of Medical Biometry, University Hospital of Heidelberg, Im Neuenheimer Feld 305, 69120, Heidelberg, Germany. bruckner@imbi.uni-heidelberg.de.
authors.forename: Thomas
authors.initials: T
authors.lastname: Bruckner
authors.affiliation: Department of Radiation Oncology, University Hospital of Heidelberg, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany. stefan.rieken@med.uni-heidelberg.de.
authors.forename: Stefan
authors.initials: S
authors.lastname: Rieken
authors.affiliation: Department of Radiation Oncology, University Hospital of Heidelberg, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany. tilmann.bostel@med.uni-heidelberg.de.
authors.forename: Tilman
authors.initials: T
authors.lastname: Bostel
authors.affiliation: Department of Radiation Oncology, University Hospital of Heidelberg, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany. robert.foerster@med.uni-heidelberg.de.
authors.forename: Robert
authors.initials: R
authors.lastname: Förster
authors.affiliation: Department of Radiation Oncology, University Hospital of Heidelberg, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany. ingmar.schlampp@med.uni-heidelberg.de.
authors.forename: Ingmar
authors.initials: I
authors.lastname: Schlampp
authors.affiliation: Department of Radiation Oncology, University Hospital of Heidelberg, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany. robert.wolf@med.uni-heidelberg.de.
authors.forename: Robert
authors.initials: R
authors.lastname: Wolf
authors.affiliation: Department of Radiation Oncology, University Hospital of Heidelberg, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany. juergen.debus@med.uni-heidelberg.de.|Heidelberg Institute of Radiation Oncology, Im Neuenheimer Feld 280, 69120, Heidelberg, Germany. juergen.debus@med.uni-heidelberg.de.
authors.forename: Jürgen
authors.initials: J
authors.lastname: Debus
authors.affiliation: Department of Radiation Oncology, University Hospital of Heidelberg, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany. florian.sterzing@med.uni-heidelberg.de.|Heidelberg Institute of Radiation Oncology, Im Neuenheimer Feld 280, 69120, Heidelberg, Germany. florian.sterzing@med.uni-heidelberg.de.
authors.forename: Florian
authors.initials: F
authors.lastname: Sterzing
mesh_terms: D002985:Clinical Protocols; D019583:Dose Fractionation, Radiation; D005221:Fatigue / Q000209:etiology / Q000523:psychology; D005858:Germany; D006801:Humans; D010146:Pain / Q000175:diagnosis / Q000209:etiology / Q000532:radiotherapy*; D010147:Pain Measurement; D010166:Palliative Care; D011446:Prospective Studies; D011788:Quality of Life; D016634:Radiosurgery / Q000009:adverse effects / Q000379:methods*; D050397:Radiotherapy, Intensity-Modulated / Q000009:adverse effects / Q000379:methods*; D012107:Research Design; D013125:Spinal Neoplasms / Q000150:complications / Q000401:mortality / Q000532:radiotherapy* / Q000556:secondary; D013997:Time Factors; D016896:Treatment Outcome