Radiation-induced toxicity after image-guided and intensity-modulated radiotherapy versus exterior beam radiotherapy for sufferers with spinal bone metastases (IRON-1): a examine protocol for a randomized managed pilot trial.
Trials. 2017 Mar 03;18(1):98
Authors: Meyerhof E, Sprave T, Welte SE, Nicolay NH, Förster R, Bostel T, Bruckner T, Schlampp I, Debus J, Rief H
BACKGROUND: Radiation remedy (RT) of bone metastases supplies an vital remedy method in palliative care remedy ideas. As a consequence of remedy, the extent of radiation-induced toxicity is a vital characteristic with penalties to a affected person’s high quality of life. On this context this examine goals at lowering the extent of radiation-induced uncomfortable side effects and toxicity by assuming a greater sparing of regular tissue with the usage of intensity-modulated as an alternative of conventionally delivered exterior beam radiotherapy.
METHODS/DESIGN: On this potential, randomized, single-center trial for sufferers with spinal bone metastases, RT is carried out as both image-guided intensity-modulated radiotherapy (10x3Gy) or conventionally fractionated exterior beam radiotherapy (10x3Gy). Afterwards radiation-induced toxicity might be assessed and in contrast three and 6 months after the top of radiation.
DISCUSSION: The intention of this pilot examine is the analysis of achievable advantages, with diminished radiation toxicity being the first endpoint within the comparability of intensity-modulated radiotherapy versus standard radiotherapy for sufferers with spinal bone metastases. Secondarily, bone re-calcification, high quality of life, ache aid, spinal instability, and native management might be measured and in contrast between the 2 remedy teams.
TRIAL REGISTRATION: ClinicalTrials.gov, NCT02832830 . Registered on 12 July 2016.
PMID: 28253920 [PubMed – indexed for MEDLINE]