eprintid: 22707
rev_number: 12
eprint_status: archive
userid: 1589
dir: disk0/00/02/27/07
datestamp: 2017-03-06 09:18:37
lastmod: 2024-04-27 17:02:53
status_changed: 2017-03-06 09:18:37
type: article
metadata_visibility: show
creators_name: Meyerhof, Eva
creators_name: Sprave, Tanja
creators_name: Welte, Stefan Ezechiel
creators_name: Nicolay, Nils H.
creators_name: Förster, Robert
creators_name: Bostel, Tilman
creators_name: Bruckner, Thomas
creators_name: Schlampp, Ingmar
creators_name: Debus, Jürgen
creators_name: Rief, Harald
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
subjects: ddc-610
divisions: i-911400
divisions: i-911800
abstract: Background: 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.   Methods/design: 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.   Discussion: 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.   Trial registration: ClinicalTrials.gov, NCT02832830. Registered on 12 July 2016.
date: 2017
publisher: BioMed Central
id_scheme: DOI
ppn_swb: 1656958244
own_urn: urn:nbn:de:bsz:16-heidok-227079
language: eng
bibsort: MEYERHOFEVRADIATIONI2017
full_text_status: public
publication: Trials
volume: 18
number: 98
place_of_pub: London
pagerange: 1-5
issn: 1468-6694
citation:   Meyerhof, Eva ; Sprave, Tanja ; Welte, Stefan Ezechiel ; Nicolay, Nils H. ; Förster, Robert ; Bostel, Tilman ; Bruckner, Thomas ; Schlampp, Ingmar ; Debus, Jürgen ; Rief, Harald  (2017) 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.  Trials, 18 (98).  pp. 1-5.  ISSN 1468-6694     
document_url: https://archiv.ub.uni-heidelberg.de/volltextserver/22707/1/13063_2017_Article_1847.pdf