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01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Trials 1/2018

Intensity-modulated radiotherapy with integrated-boost in patients with bone metastasis of the spine: study protocol for a randomized controlled trial

Zeitschrift:
Trials > Ausgabe 1/2018
Autoren:
Tanja Sprave, Stefan Ezechiel Welte, Thomas Bruckner, Robert Förster, Tilman Bostel, Ingmar Schlampp, Nils Henrik Nicolay, Jürgen Debus, Harald Rief
Wichtige Hinweise

Electronic supplementary material

The online version of this article (https://​doi.​org/​10.​1186/​s13063-018-2452-7) contains supplementary material, which is available to authorized users.

Abstract

Background

Stereotactic body radiation therapy (SBRT) using intensity-modulated radiotherapy (IMRT) with dose escalation by simultaneous integrated boost (SIB) can be a safe modality for treating spinal bone metastases with enhanced targeting accuracy and improve local tumor control.

Methods/Design

This is a single-center, prospective, randomized, controlled trial. One hundred and twenty patients with spinal bone metastases will receive palliative radiation therapy at the Heidelberg University Hospital. SBRT will be given in five or ten fractions with or without SIB. Four treatment arms are planned: IMRT with 30 Gy in ten fractions, IMRT with 30 Gy in ten fractions and SIB to 40 Gy, IMRT with 20 Gy in five fractions, and IMRT with 20 Gy in five fractions and SIB to 30Gy in five fractions will be compared. The target parameters will be measured at baseline level and at three and six months after radiation.

Discussion

The primary endpoint of this study was to assess and compare the local tumor control (by means of different fractionation schedules and biological doses to the tumor area). Secondary endpoints are acute and chronic adverse events, pain relief, quality of life, and fatigue.

Trial registration

ClinicalTrials.gov, NCT02832765. Registered on 27 July 2016.
Zusatzmaterial
Additional file 1: SPIRIT 2013 Checklist: Recommended items to address in a clinical trial protocol and related documents. The additional SPIRIT 2013 Checklist file shows this in more detail. (DOC 121 kb)
13063_2018_2452_MOESM1_ESM.doc
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