A randomised trial of intravesical irrigation in superficial bladder cancer followed by treatment with epodyl or mitomycin C at the time of first recurrence

ISRCTN	ISRCTN88118697
DOI	https://doi.org/10.1186/ISRCTN88118697
Secondary identifying numbers	BS04

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr Danielle Andrews
Scientific

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

Phone	+44 (0)20 7636 5422
Email	clinical.trial@headoffice.mrc.ac.uk

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 to request a patient information sheet
Scientific title	A randomised trial of intravesical irrigation in superficial bladder cancer followed by treatment with epodyl or mitomycin C at the time of first recurrence
Study objectives	1. To detect the reduction, if any, of recurrence following irrigation of the bladder with glycine following complete resection of newly diagnosed bladder cancer 2. To compare the effect of Mitomycin-C against Epodyl in patients who develop recurrent superficial tumour following the initial transurethral resection in preventing further recurrence
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Bladder cancer
Intervention	Epodyl or mitomycin C Follow-up: 3 monthly for 1st year, 6 monthly for 2nd year, annually thereafter.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Epodyl or mitomycin C
Primary outcome measure	Recurrence free survival
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/07/1987
Completion date	01/12/1995

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	1000
Key inclusion criteria	1. Newly diagnosed superficial bladder cancer suitable for complete endoscopic resection 2. Transitional cell carcinoma limited to the bladder, no evidence of carcinoma in the upper tracts 3. World Health Organisation (WHO) performance status 0-2 4. Expected survival at least 3 years 5. White count greater than 3 x 10^9/L and platelets greater than 100 x 10^9/L 6. No untreated urinary tract infection
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/07/1987
Date of final enrolment	01/12/1995

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

19/02/2018: No publications found, verifying study status with principal investigator.
17/11/2015: No publications found on PubMed.