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.
journal_name
Trialsjournal_title
Trialsauthors
Meyerhof E,Sprave T,Welte SE,Nicolay NH,Förster R,Bostel T,Bruckner T,Schlampp I,Debus J,Rief Hdoi
10.1186/s13063-017-1847-1subject
Has Abstractpub_date
2017-03-03 00:00:00pages
98issue
1issn
1745-6215pii
10.1186/s13063-017-1847-1journal_volume
18pub_type
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