Table 2.
Study calendar for measurements of study endpoints.
| Assessment | Baseline (preoperative) | Hospital discharge (±2 weeks) | Follow-up assessments
|
|||||
|---|---|---|---|---|---|---|---|---|
| 4–6 weeks | 3 months | 6 months | 12 months | 24 months | 36 months | |||
| Baseline history and physical examination, consent, screening, ECOG performance status, TURBT findings | √ | |||||||
| Randomization | √ (≤60 days before surgery) | |||||||
| PFS | √ | √ | √ | |||||
| OS | √ | √ | √ | √ | √ | √ | ||
| ADL score | √ | √ (±30 days) | √ (±30 days) | √ (±30 days) | ||||
| IADL score | √ | √ (±30 days) | √ (±30 days) | √ (±30 days) | ||||
| Hand Grip Strength test | √ | √ (±30 days) | √ (±30 days) | √ (±30 days) | ||||
| Timed Up and Go Walking test | √ | √ (±30 days) | √ (±30 days) | √ (±30 days) | ||||
| Haemoglobin, BMP, serum albumin | √ | √ | √ | √ | √ | √ | √ | |
| HRQL questionnaire – FACT-VCI and SF-8 | √ | √ (±30 days) | √ (±30 days) | |||||
| Obtain pathology reports for surgical margin status and lymph node count | √ | |||||||
| Surgical complications per modified Clavien classification (AEs/SAEs) | √ | √ | √ | √ | √ | √ | ||
| Postoperative complication rates (Surgeon’s 90-day Data Form) | √ | |||||||
| Imaging (CT/MRI of abdomen/pelvis/chest) | √ | √ | √ | √ | ||||
| Operating room costs, Hospital costs | √ | |||||||
| Surgeon’s intraoperative data, cystectomy, pathology | Postoperative | |||||||
| Length of hospital stay, analgesics, complications (Surgeon’s Postoperative Data Form) | √ | |||||||
| Target lesions (Post-Surgical Disease Assessment Form) | √ | √ | √ | √ | ||||
BMP, basic metabolic panel; ECOG, Eastern Cooperative Oncology Group.