Table 3.

Randomized trials on SBRT for spinal metastases^a

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

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

^aExcluding studies on oligometastases including spinal oligometastatic disease, comparing surgery with SBRT, and studies including non-spinal lesions as well

^bTime point at which endpoint is measured not given