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Table 1 Selection criteria for the VERTICAL study

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

Inclusion criteria

Exclusion criteria

Participant in PRESENT cohort

Lesion in C1, and C2

Filling out PRESENT-questionnaires

Contraindication for MRI if MRI is indicated

Broad consent for randomization to experimental interventions

Radiosensitive histology such as multiple myeloma

Histologic proof of malignancy

Unable to undergo SBRT treatment

Imaging evidence of bone metastases

Patient with < 3 months life expectancy

For spinal lesions, per lesion no more than 3 consecutive spine segments involved with one unaffected vertebral body above and below

Chemotherapy or systemic radionuclide delivery within 24 h before and after SBRT

No more than 2 painful lesions needing treatment

Previous EBRT or SBRT to same level

For spinal lesions, no compression of spinal cord

For spinal lesions, unstable spine requiring surgical stabilization

No or mild neurological signsa

Severe, worsening or progressive neurological deficit

KPS > 50 and pain score > 3b

  1. VERTICAL randomized controlled trial comparing conVEntional RadioTherapy with stereotactIC body radiotherapy in patients with spinAL metastases; PRESENT Prospective Evaluation of interventional StudiEs on boNe meTastases (PRESENT) cohort; MRI magnetic resonance imaging; SBRT stereotactic body radiotherapy; EBRT external beam radiotherapy; KPS Karnofsky performance score
  2. aradiculopathy, dermatomal sensory change, and muscle strength of involved extremity is Medical Research Counsil (MRC) 4/5
  3. bon a scale from 0 to 10