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Table 2 Summary of primary and secondary endpoints

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

Endpoint definitions and measurement
Primary outcome measure
Pain control (efficacy and pain; time frame 3 months)
Overall pain control measured according to IBMC (complete response + partial response events)
Secondary outcomes measures
 • Pain control duration (efficacy and pain; time frame 12 months after end of radiotherapy)
Interval from the end of the RT to relapse of the symptom
 • Rate of retreatments (efficacy; time frame 12 months after end of radiotherapy)
Interval from the end of the RT to the start of retreatment
 • Local control (efficacy; time frame 3, 6, and 12 months from the end of radiotherapy)
Control of local disease with diagnostic exams according to RECIST 1.1 criteria
 • Symptom progression-free survival (SPFS) (efficacy and pain); time frame 12 months after end of radiotherapy)
Interval from the end of radiotherapy and progressive disease with symptoms according to the criteria of Chow et al. in 2012 [8]
 • Progression-free survival (efficacy; time frame 12 months)
Interval from the end of radiotherapy and new disease progression
 • Overall survival (efficacy; time frame 12 months)
Interval between the end of radiotherapy and death
 • Quality of life (efficacy and quality of life; time frame first visit, 1 month, and 3 months after the end of radiotherapy)
Quality of life score according to European Organization for Research and Treatment of Cancer (EORTC) QLQ-C15-PAL and QLQ– BM22 questionnaires