Skip to main content

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