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Clinical Trial
. 2019 Oct 28;19(1):1011.
doi: 10.1186/s12885-019-6259-z.

SUPR-3D: A randomized phase iii trial comparing simple unplanned palliative radiotherapy versus 3d conformal radiotherapy for patients with bone metastases: study protocol

Robert Olson  1   2   3 , Roel Schlijper  4   5 , Nick Chng  5 , Quinn Matthews  5 , Marco Arimare  6 , Lindsay Mathews  6   5 , Fred Hsu  7 , Tanya Berrang  8 , Alexander Louie  9 , Benjamin Mou  10 , Boris Valev  5 , Joanna Laba  11 , David Palma  11 , Devin Schellenberg  12 , Shilo Lefresne  4   13
Affiliations
Clinical Trial

SUPR-3D: A randomized phase iii trial comparing simple unplanned palliative radiotherapy versus 3d conformal radiotherapy for patients with bone metastases: study protocol

Robert Olson et al. BMC Cancer. .

Abstract

Background: Bone metastases in the lower spine and pelvis are effectively palliated with radiotherapy (RT), though this can come with side effects such as radiation induced nausea and vomiting (RINV). We hypothesize that high rates of RINV occur in part because of the widespread use of inexpensive simple unplanned palliative radiotherapy (SUPR), over more complex and resource intensive 3D conformal RT, such as volumetric modulated arc therapy (VMAT).

Methods: This is a randomized, multi-centre phase III trial of SUPR versus VMAT. We will accrue 250 patients to assess the difference in patient-reported RINV. This study is powered to detect a difference in quality of life between patients treated with VMAT vs. SUPR.

Discussion: This trial will determine if VMAT reduces early toxicity compared to SUPR and may provide justification for this more resource-intensive and costly form of RT.

Trial registration: Clinicaltrials.gov identifier: NCT03694015 . Date of registration: October 3, 2018.

Keywords: Bone metastases; Quality of life; Radiation-induced nausea and vomiting; Radiotherapy.

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Conflict of interest statement

Dr. Olson and Dr. Schellenberg have received grant funding from Varian Medical Systems, unrelated to this trial.

Figures

Fig. 1
Fig. 1
Dose distributions for a SUPR plan (a, c) and VMAT plan (b, d)
Fig. 2
Fig. 2
Study design
See this image and copyright information in PMC

References

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    1. Feyer P, Maranzano E, Molassiotis A, et al. Radiotherapy-induced nausea and vomiting (RINV): MASCC/ESMO guideline for antiemetics in radiotherapy: update 2009. Support Care Cancer. 2011;19:5–14. doi: 10.1007/s00520-010-0950-6. - DOI - PubMed
    1. Teoh M, Clark CH, Wood K, et al. Volumetric modulated arc therapy: a review of current literature and clinical use in practice. Br J Radiol. 2011;84:967. doi: 10.1259/bjr/22373346. - DOI - PMC - PubMed

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