drugset / Trial / NCT01616875
Bristol Bladder Trial
Phase 2
Completed
28 enrolled
University Hospitals Bristol and Weston NHS Foundation Trust
Sanofi · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cabazitaxel | Other / unclassified | 15 mg/m2 | Intravenous |
| Subject | Cisplatin | Other / unclassified | 70 mg/m2 | Intravenous |