FLASH radiotherapy for the treatment of symptomatic bone metastases in the thorax (FAST-02): protocol for a prospective study of a novel radiotherapy approach

Table 2 Schedule of activities

	Treatment Simulation to Treatment Delivery (≤ 10 business days)				Post Treatment Follow-up
Event	Enrollment, baseline (1–2 weeks)	Prep for treat-ment	Prior to treatment delivery (Day 1)	Treatment delivery (Day 1)	After treatment delivery (Day 1)	Day 2 - Day 11 (daily)¹	Day 2 (± 1 calendar day)	Day 7 (± 2 business days)	Day 15 (± 2 business days)	Month 1 (± 5 business days)	Months 2, 3, 6, 9, 12, then every 6 months
Patient screening (initial inclusion/ exclusion criteria)	X
Informed consent	X
Demographics	X
Disease information	X
CT-based simulation		X
Treatment planning		X
Treatment plan QA		X
FLASH treatment delivery				X
Questionnaire for pain flare assessment			X			X
Questionnaire for overall pain assessment			X					X	X	X	X
Questionnaire for pain assessment at treated sites			X					X	X	X	X
Subject evaluation²	X		X					X	X	X	X
Review of pain medication (including steroid medications)			X			X		X	X	X	X
AE evaluation³					X		X⁴	X	X	X	X

¹ Day 2-Day 11 subject evaluation: review of pain medications (including steroid medications) and pain flare assessment will be completed by telephone check-in.
² Includes performance status and physical evaluation with skin photographs.
³ All AEs and SAEs will be captured regardless of severity or attribution.
⁴ Day 2 AE check will be carried out through a remote visit.

ISSN: 1748-717X