Health Condition 1: C679- Malignant neoplasm of bladder, unspecified
Conditions
Interventions
Intervention1: Nil: Nil
Sponsors
DR VARUN GOEL
Eligibility
Inclusion criteria
Inclusion criteria: Patients with histologically confirmed urothelial carcinoma of the bladder, clinical stage cT greater than 2-4a,N+,M0, who received neoadjuvant chemotherapy (NAC) followed by radical cystectomy
Exclusion criteria
Exclusion criteria: Patients were excluded from the study if they had non-urothelial histology and did not receive at least one cycle of the planned neoadjuvant chemotherapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of this retrospective study was pathological complete response (pCR), defined as ypT0N0 at cystectomy.Timepoint: following completion of neoadjuvant chemotherapy i.e. 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| pathological downstaging to less than or equal to ypT1N0, overall survival (OS), disease-free survival (DFS), & documented adverse events (grade greater than or wqual to 3 according to CTCAE v5.0).Timepoint: Pathological downstaging assessed at radical cystectomy after 12 weeks. Overall survival measured from treatment start with follow-up every 3 months for 2 years then every 6 months. Disease-free survival measured from surgery with same follow-up. Adverse events grade 3 or higher monitored during each chemo cycle every 3 weeks at completion of neoadjuvant chemo after 12 weeks & during follow-up every 3 months for 2 years then every 6 months. | — |
Countries
India
Contacts
Public ContactDR VARUN GOEL
RAJIV GANDHI CANCER INSTITUTE AND RESEARCH CENTER
Outcome results
None listed