A phase III study of primary chemotherapy in T2 (G3), T3 and T4a; N0 or NX; M0 transitional cell carcinoma (TCC) of the bladder
| ISRCTN | ISRCTN82694463 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN82694463 |
| Protocol serial number | BA06 |
| Sponsor | Medical Research Council (MRC) (UK) |
| Funder | Medical Research Council (MRC) (UK) |
- Submission date
- 13/03/2001
- Registration date
- 13/03/2001
- Last edited
- 09/07/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Barbara Uscinska
Scientific
Scientific
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | |
| Study objectives | 1. To determine the survival advantage of the addition of three cycles of cisplatin, methotrexate and vinblastine (CMV) chemotherapy prior to definitive radiotherapy and/or cystectomy 2. To determine the morbidity and mortality of definitive treatment together with any additional toxicity arising from CMV chemotherapy 3. To determine the prognostic significance of downstaging to T0 following CMV chemotherapy Collaboration with the European Organization for Research and Treatment of Cancer (EORTC), Australian Bladder Cancer Study Group, Norwegian Bladder Cancer Study Group, Club Urologico Espanol de Tratamiento Group, Finnbladder and National Cancer Institute, Canada. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Bladder cancer |
| Intervention | Primary chemotherapy in T2 (G3), T3 and T4a; N0 or NX; M0 TCC of the bladder |
| Intervention type | Drug |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Chemotherapy |
| Primary outcome measure(s) |
Survival |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 10/07/1995 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | All |
| Target sample size at registration | 975 |
| Key inclusion criteria | 1. Histologically proven TCC of the bladder with biopsy-proven muscle invasion 2. Tumours considered curable (less than or equal to 7 cm) 3. GFK ≥50 ml/min (Cockcroft) 4. White blood count (WBC) >3.5 x 10^9/L and platelet count >100 x 10^9/L |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/12/1989 |
| Date of final enrolment | 10/07/1995 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 14/08/1999 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
