Abstract
BackgroundBone 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).MethodsThis 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.DiscussionThis 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 registrationClinicaltrials.gov identifier: NCT03694015.Date of registration: October 3, 2018.
Highlights
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)
Pain flare, and erythema in the irradiated area are relatively common adverse effects associated with treating bone metastases, sitespecific toxicity can occur, including esophagitis, nausea, or diarrhea when dose is delivered to the gastrointestinal tract
This study has been designed to compare early toxicity between two radiation treatment techniques currently used for palliative treatment of bone metastases, with vastly different resources required to implement
Summary
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.
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