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 SREc | ||
|---|---|---|---|---|---|---|---|
| 3 mo | 6 mo | 12 mo | |||||
| 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 studiesd | X | Xa | Xa | Xa | Xa | ||
| History and physical | X | Xb | Xb | Xb | Xb | ||
| 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