Early palliative radiation versus observation for high-risk asymptomatic or minimally symptomatic bone metastases: study protocol for a randomized controlled trial

Table 3 Study schedule for enrollment and assessment

Timeframe	Pre-registration	Within 4 weeks of study entry	Once every 5 treatment days during radiation	N months following randomization +/− 4 weeks			Within 1 week of SRE^c
Timeframe	Pre-registration	Within 4 weeks of study entry	Once every 5 treatment days during radiation	3 mo	6 mo	12 mo	Within 1 week of SRE^c
Standard of care biopsy of a metastatic lesion or pathology review confirming metastatic cancer	X
CBC with differential		X		X	X	X	X
CMP		X
Imaging studies^d		X		X^a	X^a	X^a	X^a
History and physical		X		X^b	X^b	X^b	X^b
Performance status		X		X	X	X	X
Adverse Events evaluation (CTCAE v4.0)			X	X	X	X	X
BPI short form		X	X	X	X	X	X
EQ-5D-5L		X		X	X	X	X
Lesions Identification worksheet		X

^aFollow-up imaging at discretion of treating physician. The same imagining modality is encouraged for assessment between time points
^bPatient’s height not needed at follow-ups and SRE
^cAll assessments following an SRE are optional, but highly recommended
^dBaseline imaging can be obtained within 6 weeks of study entry

ISSN: 1471-2407