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Table 3 Study schedule for enrollment and assessment

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

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