A randomised trial of epirubicin versus mitomycin C at the time of first recurrence in superficial bladder cancer

ISRCTN	ISRCTN77353795
DOI	https://doi.org/10.1186/ISRCTN77353795
Protocol serial number	BS07
Sponsor	Medical Research Council (MRC) (UK)
Funder	Medical Research Council (MRC) (UK)

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A randomised trial of epirubicin versus mitomycin C at the time of first recurrence in superficial bladder cancer
Study objectives	1. To detect the reduction, if any, in recurrence following irrigation of the bladder with glycine or saline for a minimum of 18 hours after complete resection of newly-diagnosed superficial bladder cancer. 2. To compare the effect of Mitomycin C against Epodyl in preventing further recurrence in patients who have developed a recurrent superficial tumour after the initial transurethral resection.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Bladder cancer
Intervention	First randomisation is between irrigation of the bladder with glycine/saline and no irrigation. The second randomisation is between Epodye and mitomycin C.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Epirubicin versus mitomycin C
Primary outcome measure(s)	Local recurrence, time to progression, metastases, morbidity
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/01/1998

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	800
Key inclusion criteria	1. Newly-diagnosed superficial carcinoma of bladder suitable for complete endoscopic resection, limited to the bladder 2. World Health Organisation (WHO) status zero to two 3. Expected survival at least three years 4. No history of other malignant tumours, except non-melanomatous skin tumours, or carcinoma in-situ (CIN) 5. No untreated urinary tract infection (UTI)
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	22/04/1994
Date of final enrolment	01/01/1998

MRC Clinical Trials Unit

London
NW1 2DA
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

13/02/2018: No publications found in PubMed, study status unverified
30/11/2015: No publications found in PubMed.