Clinical trial · Interventional
Bristol Bladder Trial
A Phase II Trial of Combination Cabazitaxel and Cisplatin Chemotherapy in the Neo-adjuvant Treatment of Transitional Cell Carcinoma of the Urinary Bladder
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Infiltrating Bladder Urothelial Carcinoma | Invasive Bladder Urothelial Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cabazitaxel + Cisplatin chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cabazitaxel + Cisplatin chemotherapy
- description
- Cabazitaxel 15mg/m2 Intravenous (IV)followed by Cisplatin 70mg/m2 IV on day 1 of each 21 day cycle for 4 cycles
- interventionNames
- Drug: Cabazitaxel + Cisplatin chemotherapy
Primary outcomes (1)
- measure
- Overall Pathological Response Rate
- timeFrame
- Histological assessment of radical cystectomy specimen expected to be 15 weeks after commencing study chemotherapy.
- description
- Pathological stage at diagnosis (T2/T3 - see baseline characteristics) was compared to pathological stage of the surgical specimen at cystectomy. A response is considered as a decrease in T stage from T2/T3 seen at baseline to T1 or less indicating a reduction in tumour size/invasiveness. The T stage describes how far the primary tumour has spread. The higher the stage the further the tumour has grown through the bladder wall and into the surrounding tissues. The stages are Ta - non-invasive papillary carcinoma, Tis - flat non-invasive carcinoma, T1 - grown through the connective tissue but not into the muscle of the bladder wall, T2 - tumour has grown through the connective tissue and into the muscle of the bladder wall, T3 - tumour has grown through the muscle and into the fatty layer surrounding the bladder and T4 - the cancer has spread to surrounding tissues.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥18 years * Histologically confirmed primary transitional cell carcinoma (TCC) of the urinary bladder * T2 to T4 disease, N0 M0 determined by computerised tomography (CT) imaging and biopsy or transurethral resection * Eastern Co-operative Oncology Group (ECOG) Performance status 0 or 1 * Glomerular filtration rate (GFR) ≥60ml/min. * Written, informed consent Exclusion Criteria * ECOG Performance Status ≥ 2 * Lymph node involvement or metastatic disease * Prior surgery (except transurethral resection of bladder tumour), radiation, chemotherapy, or other anti-cancer therapy within 4 weeks prior to enrolment * Active Grade ≥2 peripheral neuropathy * Active secondary cancers * History of severe hypersensitivity reaction (≥Grade 3) to polysorbate 80 containing drugs * Other concurrent serious illness or medical conditions * Inadequate organ function as evidenced by peripheral blood counts at enrolment: * Electrocardiogram (ECG) evidence of uncontrolled cardiac arrhythmias, angina pectoris, and/or hypertension, history of congestive heart failure, or myocardial infarction within last 6 months. * Uncontrolled diabetes mellitus. * Active uncontrolled gastro-oesophageal reflux disease (GORD). * Active infection requiring systemic antibiotic or anti-fungal medication * Participation in another clinical trial with any investigational drug within 30 days prior to study enrolment. * Concurrent or planned treatment with strong inhibitors of cytochrome P450 3A4/5. A 1-week washout period is necessary for patients who are already on these treatments. * Concurrent or planned treatment with strong inducers of cytochrome P450 3A4/5. A 1-week washout period is necessary for patients who are already on these treatments. * Contraindications to cisplatin. * Patient with reproductive potential not implementing an accepted and effective method of contraception.
References
Publications (1)
- RESULTChallapalli A, Masson S, White P, Dailami N, Pearson S, Rowe E, Koupparis A, Oxley J, Abdelaziz A, Ash-Miles J, Bravo A, Foulstone E, Perks C, Holly J, Persad R, Bahl A. A Single-arm Phase II Trial of Neoadjuvant Cabazitaxel and Cisplatin Chemotherapy for Muscle-Invasive Transitional Cell Carcinoma of the Urinary Bladder. Clin Genitourin Cancer. 2021 Aug;19(4):325-332. doi: 10.1016/j.clgc.2021.02.001. Epub 2021 Feb 18. PMID 33727028