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 |