title: Stereotactic versus conventional radiotherapy for pain reduction and quality of life in spinal metastases: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Painful spinal metastases have been treated with conventional radiotherapy for decades, but one-third of the patients have insufficient pain relief after treatment and one-fifth need retreatment. Stereotactic radiotherapy is a method to increase the dose in the spinal metastases with a potentially longer lasting palliative effect without increasing the side effects of the treatment and thereby is expected to improve the quality of life significantly.
  
  
  METHODS
  This study is a multicenter prospective randomized clinical trial comparing conventional radiotherapy (1 x 8 Gy) with stereotactic radiotherapy (1 x 20 Gy) for pain reduction and quality of life in patients with painful spinal metastases. A total of 386 patients will be randomized between the two treatment groups. Besides pain measured by the Dutch Brief Pain Inventory, quality of life and cost-effectiveness also will be measured. The primary outcome is pain reduction at 6 weeks after treatment. Secondary outcomes will be the time to pain response, duration of pain relief, health-related quality of life and toxicity, as well as cost-effectiveness.
  
  
  CONCLUSIONS
  This study investigates whether stereotactic radiotherapy with dose escalation for symptomatic spinal metastases can lead to improved pain reduction as compared to conventional radiotherapy without an increase of treatment-related side effects. These results will contribute to the optimization and individualization of the treatment for the patient.
  
  
  BACKGROUND
  ClinicalTrials.gov identifier NCT02407795 (March 31, 2015).
authors.affiliation: Department of Radiation Oncology, Radboud University Medical Center Nijmegen, Geert Grooteplein-Zuid 32, route 874, PB 9101, Nijmegen, GA, 6525, The Netherlands. p.braam@radboudumc.nl.
authors.forename: Pètra
authors.initials: P
authors.lastname: Braam
authors.affiliation: MAASTRO Clinic, Doctor Tanslaan 12, 6229 ET, Maastricht, The Netherlands. philippe.lambin@maastro.nl.
authors.forename: Philippe
authors.initials: P
authors.lastname: Lambin
authors.affiliation: Department of Radiation Oncology, Radboud University Medical Center Nijmegen, Geert Grooteplein-Zuid 32, route 874, PB 9101, Nijmegen, GA, 6525, The Netherlands. jan.bussink@radboudumc.nl.
authors.forename: Johan
authors.initials: J
authors.lastname: Bussink
mesh_terms: D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D023381:Endpoint Determination; D006801:Humans; D017063:Outcome Assessment, Health Care; D010148:Intractable Pain / Q000628:therapy*; D010166:Palliative Care; D018579:Patient Selection; D011446:Prospective Studies; D011788:Quality of Life; D016634:Radiosurgery / Q000379:methods*; D013125:Spinal Neoplasms / Q000523:psychology / Q000556:secondary* / Q000628:therapy*
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