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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