TY  - JOUR
SN  - 1468-6694
Y1  - 2017///
TI  - 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
SP  - 1
A1  - Meyerhof, Eva
A1  - Sprave, Tanja
A1  - Welte, Stefan Ezechiel
A1  - Nicolay, Nils H.
A1  - Förster, Robert
A1  - Bostel, Tilman
A1  - Bruckner, Thomas
A1  - Schlampp, Ingmar
A1  - Debus, Jürgen
A1  - Rief, Harald
UR  - https://archiv.ub.uni-heidelberg.de/volltextserver/22707/
N2  - 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.
JF  - Trials
CY  - London
EP  - 5
AV  - public
IS  - 98
ID  - heidok22707
VL  - 18
PB  - BioMed Central
ER  -