Table 2 Summary of primary and secondary endpoints
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 |