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Table 3 Randomized trials on SBRT for spinal metastasesa

From: Comparing conVEntional RadioTherapy with stereotactIC body radiotherapy in patients with spinAL metastases: study protocol for an randomized controlled trial following the cohort multiple randomized controlled trial design

Name, institution Start date, sample size Patients SBRT treatment Comparator Primary Endpoint
Mahadevan et al. [36]
Beth Israel Deaconess MC
01–2012
81
Number of sites not stated; Pain ≥ 5; No rapid neurologic decline Total dose unknown in 1, 3, or 5 fractions; No more information provided Standard EBRT in 10 fractions Pain responseb
RACOST [37]
Radboud UMC Nijmegen
06–2015
382
Number of sites not stated; May have other visceral metastases; Pain ≥ 5; No neurologic deficit Any modern system; 20 Gy in one fraction; Delineation with MRI and CT; Target volume is GTV, with bony CTV expansion, PTV margin ≤ 3 mm Standard EBRT single dose of 8 Gy, no restrictions to radiation technique Pain response taking administration of opioids into accountb
RTOG 0631 [38]
Henry Ford Hospital
11–2011
395
Up to 3 spinal sites; May have other visceral metastases; Pain ≥ 5; No rapid neurologic decline IMRT or other dose painting technique; 16 or 18 Gy in one fraction; Delineation with MRI and CT; Target volume is involved VB Standaard EBRT single dose of 8 Gy, 2D and 3D conformal therapy Pain response (increase or decrease of ≥ 3 points) at 3 months
SMART [39] Heidelberg University 12–2014
60
Up to 2 spinal sites; No neurologic deficit IMRT; 24 Gy in one fraction; Delineation with CT; Target volume is involved VB with PTV margin Standard EBRT 30 Gy in 10 fractions, 3D conformal planning Pain response (increase or decrease of > 2 points) at 3 months
SPIN-MET [40] University of Erlangen-Nürnberg 03–2013
155
Number of sites not stated; May have other visceral metastases; No rapid neurologic decline 36 Gy in 12 fractions plus integrated boost 48 Gy in 12 fractions; No more information provided Conventional EBRT 30 Gy in 10 fractions Tumor control defined as time to progression on MRI
Tingting et al. [41] Cancer Hospital of Shantou UMC 03–2014
100
Up to 3 spinal sites 24 Gy in 2 fractions; No more information provided Conventional EBRT 30 Gy in 10 fractions Pain response taking administration of opioid into accountb
VERTICAL
University Medical Center Utrecht
01–2015
110
Up to 2 spinal sites; May have other visceral metastases; Pain ≥ 3; no rapid neurologic decline VMAT; 18 Gy in one fraction or fractionated equivalent; Delineation with MRI and CT; Target volume with simultaneous integrated boost Standard of care for standard radiotherapy Pain response (increase or decrease of ≥ 2 points) taking administration of opioid into account at 3 months
  1. CT computed tomography, CTV clinical target volume, EBRT external beam radiotherapy, IMRT image guided radiotherapy, GTV gross tumor volume, MC medical center, MRI magnetic resonance imaging, PTV planning target volume, VB vertebral body
  2. aExcluding studies on oligometastases including spinal oligometastatic disease, comparing surgery with SBRT, and studies including non-spinal lesions as well
  3. bTime point at which endpoint is measured not given