title: Biological 18[F]-FDG-PET image-guided dose painting by numbers for painful uncomplicated bone metastases: A 3-arm randomized phase II trial.
abstract: BACKGROUND
  Antalgic radiotherapy for bone metastases might be improved by implementing biological information in the radiotherapy planning using (18)F-FDG-PET-CT based dose painting by numbers (DPBN).
  
  
  METHODS
  Patients with uncomplicated painful bone metastases were randomized (1:1:1) and blinded to receive either 8Gy in a single fraction with conventionally planned radiotherapy (arm A) or 8Gy in a single fraction with DPBN (dose range between 610Gy and 10Gy) (arm B) or 16Gy in a single fraction with DPBN (dose range between 1410Gy and 18Gy) (arm C). The primary endpoint was overall pain response at 1month. The phase II trial was designed to select the experimental arm with sufficient promise of efficacy to continue to a phase III trial.
  
  
  RESULTS
  Forty-five patients were randomized. Eight (53%), 12 (80%) and 9 patients (60%) had an overall response to treatment in arm A, B and C, respectively. The estimated odds ratio of overall response for arm B vs. A is 3.5 (95% CI: 0.44-17.71, p=0.12). The estimated odds ratio of arm C vs. A is 1.31 (95% CI: 0.31-5.58, p=0.71).
  
  
  CONCLUSIONS
  A single fraction of 8Gy with DPBN will be further evaluated in a phase III-trial.
authors.affiliation: Department of Radiotherapy, Ghent University Hospital, Belgium.
authors.forename: Dieter
authors.initials: D
authors.lastname: Berwouts
authors.affiliation: Department of Radiotherapy, Ghent University Hospital, Belgium.
authors.forename: Katrien
authors.initials: K
authors.lastname: De Wolf
authors.affiliation: Department of Nuclear Medicine, Ghent University Hospital, Belgium.
authors.forename: Bieke
authors.initials: B
authors.lastname: Lambert
authors.affiliation: Department of Radiotherapy, Ghent University Hospital, Belgium.
authors.forename: Renée
authors.initials: R
authors.lastname: Bultijnck
authors.affiliation: Department of Radiotherapy, Ghent University Hospital, Belgium.
authors.forename: Wilfried
authors.initials: W
authors.lastname: De Neve
authors.affiliation: Department of Applied Mathematics, Computer Science and Statistics Ghent University, Belgium.
authors.forename: Lizzy
authors.initials: L
authors.lastname: De Lobel
authors.affiliation: Department of Radiology, Ghent University Hospital, Belgium.
authors.forename: Lennart
authors.initials: L
authors.lastname: Jans
authors.affiliation: Department of Applied Mathematics, Computer Science and Statistics Ghent University, Belgium.
authors.forename: Els
authors.initials: E
authors.lastname: Goetghebeur
authors.affiliation: Department of Radiotherapy, Ghent University Hospital, Belgium.
authors.forename: Bruno
authors.initials: B
authors.lastname: Speleers
authors.affiliation: Department of Radiotherapy, Ghent University Hospital, Belgium.
authors.forename: Luiza A M
authors.initials: LA
authors.lastname: Olteanu
authors.affiliation: Department of Radiotherapy, Ghent University Hospital, Belgium.
authors.forename: Indira
authors.initials: I
authors.lastname: Madani
authors.affiliation: Department of Nuclear Medicine, Ghent University Hospital, Belgium.
authors.forename: Ingeborg
authors.initials: I
authors.lastname: Goethals
authors.affiliation: Department of Radiotherapy, Ghent University Hospital, Belgium. Electronic address: piet.ost@ugent.be.
authors.forename: Piet
authors.initials: P
authors.lastname: Ost
mesh_terms: D000368:Aged; D001132:Arm; D001859:Bone Neoplasms / Q000150:complications / Q000000981:diagnostic imaging* / Q000532:radiotherapy*; D005260:Female; D019788:Fluorodeoxyglucose F18; D006801:Humans; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000209:etiology*; D010147:Pain Measurement; D010151:Paintings; D049268:Positron-Emission Tomography; D011829:Radiation Dosage; D011880:Radiotherapy Planning, Computer-Assisted
chemical_list: D019788:Fluorodeoxyglucose F18
keywords: Bone Metastasis; Dose-painting-by-numbers; Pain response; Palliative treatment; Stereotactic body radiotherapy