title: Radiation-induced toxicity after image-guided and intensity-modulated radiotherapy versus external beam radiotherapy for patients with spinal bone metastases (IRON-1): a study protocol for a randomized controlled pilot trial.
abstract: Radiation therapy (RT) of bone metastases provides an important treatment approach in palliative care treatment concepts. As a consequence of treatment, the extent of radiation-induced toxicity is a crucial feature with consequences to a patient's quality of life. In this context this study aims at reducing the extent of radiation-induced side effects and toxicity by assuming a better sparing of normal tissue with the use of intensity-modulated instead of conventionally delivered external beam radiotherapy.
  
  
  
  In this prospective, randomized, single-center trial for patients with spinal bone metastases, RT is performed as either image-guided intensity-modulated radiotherapy (10x3Gy) or conventionally fractionated external beam radiotherapy (10x3Gy). Afterwards radiation-induced toxicity will be assessed and compared 3 and 6 months after the end of radiation.
  
  
  
  The aim of this pilot study is the evaluation of achievable benefits, with reduced radiation toxicity being the primary endpoint in the comparison of intensity-modulated radiotherapy versus conventional radiotherapy for patients with spinal bone metastases. Secondarily, bone re-calcification, quality of life, pain relief, spinal instability, and local control will be measured and compared between the two treatment groups.
  
  
  
  ClinicalTrials.gov, NCT02832830 . Registered on 12 July 2016.
authors.affiliation: Department of Radiation Oncology, University Hospital Heidelberg, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.|National Center for Radiation Oncology (NCRO), Heidelberg Institute for Radiation Oncology (HIRO), Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.
authors.forename: Eva
authors.initials: E
authors.lastname: Meyerhof
authors.affiliation: Department of Radiation Oncology, University Hospital Heidelberg, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.|National Center for Radiation Oncology (NCRO), Heidelberg Institute for Radiation Oncology (HIRO), Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.
authors.forename: Tanja
authors.initials: T
authors.lastname: Sprave
authors.affiliation: Department of Radiation Oncology, University Hospital Heidelberg, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.|National Center for Radiation Oncology (NCRO), Heidelberg Institute for Radiation Oncology (HIRO), Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.
authors.forename: Stefan Ezechiel
authors.initials: SE
authors.lastname: Welte
authors.affiliation: Department of Radiation Oncology, University Hospital Heidelberg, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.|National Center for Radiation Oncology (NCRO), Heidelberg Institute for Radiation Oncology (HIRO), Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.
authors.forename: Nils H
authors.initials: NH
authors.lastname: Nicolay
authors.affiliation: Department of Radiation Oncology, University Hospital Heidelberg, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.|National Center for Radiation Oncology (NCRO), Heidelberg Institute for Radiation Oncology (HIRO), Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.
authors.forename: Robert
authors.initials: R
authors.lastname: Förster
authors.affiliation: Department of Radiation Oncology, University Hospital Heidelberg, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.|National Center for Radiation Oncology (NCRO), Heidelberg Institute for Radiation Oncology (HIRO), Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.
authors.forename: Tilman
authors.initials: T
authors.lastname: Bostel
authors.affiliation: Department of Medical Biometry, University Hospital Heidelberg, Im Neuenheimer Feld 305, 69120, Heidelberg, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Bruckner
authors.affiliation: Department of Radiation Oncology, University Hospital Heidelberg, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.|National Center for Radiation Oncology (NCRO), Heidelberg Institute for Radiation Oncology (HIRO), Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.
authors.forename: Ingmar
authors.initials: I
authors.lastname: Schlampp
authors.affiliation: Department of Radiation Oncology, University Hospital Heidelberg, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.|National Center for Radiation Oncology (NCRO), Heidelberg Institute for Radiation Oncology (HIRO), Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.
authors.forename: Jürgen
authors.initials: J
authors.lastname: Debus
authors.affiliation: Department of Radiation Oncology, University Hospital Heidelberg, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany. harald.rief@med.uni-heidelberg.de.|National Center for Radiation Oncology (NCRO), Heidelberg Institute for Radiation Oncology (HIRO), Im Neuenheimer Feld 400, 69120, Heidelberg, Germany. harald.rief@med.uni-heidelberg.de.
authors.forename: Harald
authors.identifier: 0000-0003-3610-973X
authors.initials: H
authors.lastname: Rief
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002985:Clinical Protocols; D005260:Female; D005858:Germany; D006801:Humans; D008297:Male; D008875:Middle Aged; D010166:Palliative Care; D010865:Pilot Projects; D011446:Prospective Studies; D011788:Quality of Life; D011829:Radiation Dosage; D011832:Radiation Injuries / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control*; D061089:Radiotherapy, Image-Guided / Q000009:adverse effects*; D050397:Radiotherapy, Intensity-Modulated / Q000009:adverse effects*; D012107:Research Design; D012307:Risk Factors; D013125:Spinal Neoplasms / Q000000981:diagnostic imaging / Q000532:radiotherapy* / Q000556:secondary; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
keywords: Intensity-modulated radiotherapy; Palliative radiotherapy; Spinal bone metastases; Toxicity