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 |
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DOI | https://doi.org/10.1186/ISRCTN82694463 |
Secondary identifying numbers | BA06 |
- 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
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
Pharmaceutical study type(s) | |
Phase | Phase III |
Drug / device / biological / vaccine name(s) | Chemotherapy |
Primary outcome measure | Survival |
Secondary outcome measures | Not provided at time of registration |
Overall study start date | 01/12/1989 |
Completion date | 10/07/1995 |
Eligibility
Participant type(s) | Patient |
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Age group | Not Specified |
Sex | Both |
Target number of participants | 915 required, 975 entered |
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
- England
- United Kingdom
Study participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Sponsor information
Medical Research Council (MRC) (UK)
Research council
Research council
20 Park Crescent
London
W1B 1AL
United Kingdom
Phone | +44 (0)20 7636 5422 |
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clinical.trial@headoffice.mrc.ac.uk | |
Website | http://www.mrc.ac.uk |
Funders
Funder type
Research council
Medical Research Council (MRC) (UK)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | results | 14/08/1999 | Yes | No |