Bristol Bladder Trial
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|ClinicalTrials.gov Identifier: NCT01616875|
Recruitment Status : Unknown
Verified April 2017 by University Hospitals Bristol NHS Foundation Trust.
Recruitment status was: Recruiting
First Posted : June 12, 2012
Last Update Posted : April 20, 2017
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.
- Contrast Magnetic resonance imaging (MRI ) scans will be taken at baseline and after cycle 1 and cycle 3.
- 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
|Condition or disease||Intervention/treatment||Phase|
|Infiltrating Bladder Urothelial Carcinoma||Drug: Cabazitaxel + Cisplatin chemotherapy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Combination Cabazitaxel and Cisplatin Chemotherapy in the Neo-adjuvant Treatment of Transitional Cell Carcinoma of the Urinary Bladder|
|Study Start Date :||May 2012|
|Estimated Primary Completion Date :||September 2017|
|Estimated Study Completion Date :||January 2018|
Experimental: Cabazitaxel + Cisplatin chemotherapy
Cabazitaxel 15mg/m2 Intravenous (IV)followed by Cisplatin 70mg/m2 IV on day 1 of each 21 day cycle for 4 cycles
Drug: Cabazitaxel + Cisplatin chemotherapy
Cabazitaxel 15mg/m2 followed by cisplatin 70mg/m2 given intravenously on day 1 of each 3 weekly cycle for 4 cycles prior to radical cystectomy.
Other Name: Jevtana
- Overall pathological response rate [ Time Frame: Histological assessment of radical cystectomy specimen expected to be 15 weeks after commencing study chemotherapy ]
- To record progression free survival [ Time Frame: Up to 5 years following radical cystectomy ]From date of registration until the date of first documented progression or date of death from any cause whichever came first.
- To assess quality of life [ Time Frame: Up to 13 weeks from baseline ]EQ-5D and EORTC QLQC30 and BLM30 will be assessed at baseline and following each cycle of chemotherapy
- To record side effects and tolerability of treatment [ Time Frame: Up to 13 weeks from baseline ]Common toxicity criteria adverse events (CTC AE ) Version 4.03 will be assessed at baseline and following each cycle of chemotherapy
- Overall survival [ Time Frame: Up to 5 years following radical cystectomy ]From the date of registration to the date of death from any cause.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01616875
|Contact: Amit Bahl||0117 342 firstname.lastname@example.org|
|Contact: Susan Masson||0117 342 email@example.com|
|Bristol Haematology + Oncology Centre, Horfield Road||Recruiting|
|Bristol, United Kingdom, BS2 8ED|
|Contact: Sylvia Pearson 0117 3424263 firstname.lastname@example.org|
|Contact: Seonaid Wright 0117 342 2069 email@example.com|
|Principal Investigator: Amit K Bahl|
|Sub-Investigator: Susan Masson|
|Principal Investigator:||Amit K Bahl||University Hospitals Bristol NHS Foundation Trust|