Non-Muscle Invasive Bladder Cancer
Conditions
Brief summary
Complete Response (CR) Rate of high-grade disease at 3 months (defined as the absence of high-risk disease or progressive disease, assessed by cystoscopy and urine cytology, and biopsy (when applicable)
Detailed description
Adverse events (AEs)., CR rate of high-risk disease at 6, 12, 18 and 24 months., Median duration of complete response (DOR) in patients with a Complete response (CR)., Progression-free survival (PFS) to worsening of grade, stage (muscle invasive or metastatic disease) or death., Overall Survival (OS)., 6-month, 12-month, 18-month and 24-month OS and PFS to worsening of grade, stage (muscle-invasive or metastatic disease) or death.
Interventions
DRUGPF-06801591
DRUGTrodelvy 200 mg powder for concentrate for solution for infusion
Sponsors
Associacio Per A La Recerca Oncologica
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Adverse events (AEs)., CR rate of high-risk disease at 6, 12, 18 and 24 months., Median duration of complete response (DOR) in patients with a Complete response (CR)., Progression-free survival (PFS) to worsening of grade, stage (muscle invasive or metastatic disease) or death., Overall Survival (OS)., 6-month, 12-month, 18-month and 24-month OS and PFS to worsening of grade, stage (muscle-invasive or metastatic disease) or death. | — |
Primary
| Measure | Time frame |
|---|---|
| Complete Response (CR) Rate of high-grade disease at 3 months (defined as the absence of high-risk disease or progressive disease, assessed by cystoscopy and urine cytology, and biopsy (when applicable) | — |
Countries
Spain
Outcome results
None listed