University of British Columbia, Vancouver, Canada.
University of Northern British Columbia, Prince George, Canada.
BMC Cancer. 2019 Oct 28;19(1):1011. doi: 10.1186/s12885-019-6259-z.
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).
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.
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.
Clinicaltrials.gov identifier: NCT03694015 . Date of registration: October 3, 2018.
下脊柱和骨盆的骨转移经放疗(RT)有效缓解,但这可能伴有副作用,如放射性恶心和呕吐(RINV)。我们假设 RINV 发生率高的部分原因是广泛使用廉价的简单无计划姑息性放疗(SUPR),而不是更复杂和资源密集型的 3D 适形放疗,如容积旋转调强放疗(VMAT)。
这是一项 SUPR 与 VMAT 比较的随机、多中心 III 期试验。我们将招募 250 名患者,以评估患者报告的 RINV 差异。本研究的目的是检测 VMAT 治疗与 SUPR 治疗患者的生活质量差异。
这项试验将确定 VMAT 是否比 SUPR 降低早期毒性,并可能为这种资源密集型和昂贵的放疗形式提供依据。
Clinicaltrials.gov 标识符:NCT03694015。注册日期:2018 年 10 月 3 日。