Outcome | Definition |
Primary outcome | |
ic-PFS at 12 months | Kaplan-Meier estimate at 12 months. Time from randomisation to intracranial disease progression, as defined according to RANO-BM |
Secondary outcomes | |
ic-PFS | Time from randomisation to intracranial disease progression, as defined according to RANO-BM |
ec-PFS | Time from randomisation to extracranial disease progression, as defined according to response evaluation criteria in solid tumours |
PFS | Time from randomisation to any disease progression |
Overall survival | Time from randomisation to death |
Time to salvage whole-brain radiotherapy | Time from randomisation to salvage whole-brain radiotherapy |
Time to salvage stereotactic radiosurgery | Time from randomisation to salvage stereotactic radiotherapy |
Time to local brain failure | Time from randomisation to local brain failure |
Time to distant progression | Time from randomisation to distant disease progression |
Quality of life | EORTC QLQ for cancer (QLQ-C30). This is the core module of the QLQ suite. |
EORTC QLQ for brain neoplasm (QLQ-BN20). This is the brain tumour module. | |
Adverse events of special interest | Rates of the following adverse events (e.g.): radiation necrosis, neurocognitive impairment, oedema cerebral, muscle weakness right side, muscle weakness left side, fatigue, gait disturbance, headache, seizures, tremors, lethargy, dizziness, syncope, stroke and intracranial haemorrhage. |
ec-PFS, etracranial progression-free survival; EORTC, European Organization for Research and Treatment of Cancer; ic-PFS, intracranial progression-free survival; QLQ, Quality of Life Questionnaire ; RANO, response assessment in neuro-oncology.