drugset / Trial / NCT01616875

Bristol Bladder Trial

NCT01616875

NaSingle-groupOpen-labelTreatment

Summary

26 patients with invasive primary transitional cell carcinoma of the bladder will receive 4 cycles of combination chemotherapy consisting of Cabazitaxel and Cisplatin both given intravenously on day 1 of each 3 weekly cycle prior to radical cystectomy, to evaluate the overall response rate and to determine whether this approach warrants further research of a phase II/III study.Participation in 2 sub studies will also be offered to the participants. 1. Contrast Magnetic resonance imaging (MRI ) scans will be taken at baseline and after cycle 1 and cycle 3. 2. A pilot sub study involving the circulating tumour cell concentration from blood samples taken at baseline, prior to each cycle of chemotherapy and prior to surgery

Timeline

Start
2012-07-25
Primary completion
2017-11
Completion
2023-01-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Cabazitaxel Other / unclassified 15 mg/m2 Intravenous
Subject Cisplatin Other / unclassified 70 mg/m2 Intravenous