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Table 1 Summary of eligibility criteria

From: Pain REduction with bone metastases STereotactic radiotherapy (PREST): A phase III randomized multicentric trial

PREST trial eligibility criteria
Inclusion criteria Exclusion criteria
 • Patients diagnosed with spinal bone metastases from solid, uncomplicated tumor
 • Primary or secondary tumor histology related to the treatment lesion
 • Patients aged > 18 years
 • Obtained informed consent
 • ECOG 0–2
 • Symptomatic patients at the treatment site (NRS ≥ 4)
 • Symptomatic patients at the treatment site (NRS 1–3) assuming opioid therapy ongoing for more than 3 days
 • Spine Instability Neoplastic Score (SINS) < 7
 • Prognosis > 6 months according to Mizumoto Prognostic Score (i.e., classes A and B)
 • Spinal metastases verified at MRI, including the sites to be enrolled
 • No more than three non-contiguous spinal segments (e.g., separated by at least two metamers) involved in the study
• Unable to assign specific NRS for each CTV to be enrolled
• Unable to express autonomous consent to therapies
• Pregnancy
• Patient in hospice or with prognosis < 6 months
• Unavailability forecast for follow-up
• Absence of MRI pre-treatment study
• Unable to maintain the treatment position for SBRT
• Previous radiotherapy at the same site or at the level of adjoining metameres (higher or lower than the one to be enrolled)
• Previous radiometabolic therapy
• Previous enrolment of the same patient for three irradiated lesions
• Epidural compression of the spinal cord or of the cauda equina
• Injuries affecting > 25% of the medullary canal and/or a distance < 5 mm from the medulla or from the cauda
• Injuries with indication of surgical stabilization
• Chemotherapy or target therapy within the previous 7 days and 7 days after SBRT