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

Eva Meyerhof,Jürgen Debus,Stefan Ezechiel Welte,Tanja Sprave,Nils H Nicolay,Harald Rief,Thomas Bruckner,Tilman Bostel,Ingmar Schlampp,Robert Förster

doi:10.1186/s13063-017-1847-1

Eva Meyerhof, Jürgen Debus + Show 8 more

Open Access

https://doi.org/10.1186/s13063-017-1847-1

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Journal: Trials	Publication Date: Mar 3, 2017
Citations: 4	License type: open-access

Affiliation: Heidelberg University, University Hospital Heidelberg

Abstract

BackgroundRadiation 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/designIn 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.DiscussionThe 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 registrationClinicalTrials.gov, NCT02832830. Registered on 12 July 2016.

Highlights

Radiation therapy (RT) of bone metastases provides an important treatment approach in palliative care treatment concepts
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
All statistical analyses will be performed with SAS software v 9.3 or higher (SAS Institute, Cary, NC, USA). This prospective, single-center pilot trial performed at the Department of Radiation Oncology at the University Hospital of Heidelberg assesses radiation-induced toxicity 3 months after radiotherapy in patients with spinal bone metastases by comparing intensity-modulated radiotherapy versus conventional external beam radiotherapy

Summary

Introduction

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 radiationinduced 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. Fractionated external beam radiotherapy is one of the most important radiotherapeutic treatment options for spinal bone metastases, delivering common doses of 30 Gy and resulting in a significant decrease in pain [11]. The use of intensity-modulated radiotherapy aims to better spare the surrounding tissue, leading to a reduction of possible radiation-induced side effects [12]. Image,guidance matches the patient’s positioning to the treatment field and improves the accuracy of dose distribution [13]

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