A phase III, multicenter, randomized controlled trial of preoperative versus postoperative stereotactic radiosurgery for patients with surgically resectable brain metastases

Table 6 Study assessments

	Screening (within 7 days of randomization)^a	End of Protocol Treatment^b 2 days to 3 weeks	Follow-up Post-Treatment: 3, 6, 9, 12, 16, 24 months^c (± 2 weeks)
Informed consent	X
Medical history, handedness	X
ECOG performance status	X
Adverse event review	X	X	X
Steroid dose assessment	X	X	X
Urine or serum pregnancy test^d	X
Diagnostic MRI scan	X (within 30 days of randomization)		X
Quality of life questionnaires	X		X
Neurocognitive testing	X		X
Randomization^e	X
Resection with pre- or post-operative SRS		X

^aAll screening procedures must be completed within 7 days of the treatment start date. Results of tests obtained prior to signing the informed consent conducted as part of the subject’s standard care may be used if performed within 7 days before treatment; ^bThe adverse event review and concomitant/steroid dose assessment will be completed once all study treatments have concluded; ^cFollow up will commence after the last treatment date. Each follow-up visit has a window of ±2 weeks; ^dPerformed as required as per standard institutional policies; ^eRandomization will occur after all screening procedures are complete and the patient is found to be eligible for trial
Abbreviations: ECOG Eastern Cooperative Oncology Group, SRS stereotactic radiosurgery

ISSN: 1471-2407