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
Secondary identifying numbers	BA06

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Barbara Uscinska
Scientific

MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Study design	Randomised controlled trial
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

Participant type(s)	Patient
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

MRC Clinical Trials Unit

London
NW1 2DA
United Kingdom

Medical Research Council (MRC) (UK)
Research council

20 Park Crescent
London
W1B 1AL
United Kingdom

Phone	+44 (0)20 7636 5422
Email	clinical.trial@headoffice.mrc.ac.uk
Website	http://www.mrc.ac.uk

Research council

Medical Research Council (MRC) (UK)
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

Intention to publish date
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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	14/08/1999		Yes	No