Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
BS07
Study information
Scientific title
A randomised trial of epirubicin versus mitomycin C at the time of first recurrence in superficial bladder cancer
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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 names
Epirubicin versus mitomycin C
Primary outcome measure
Local recurrence, time to progression, metastases, morbidity
Secondary outcome measures
Not provided at time of registration
Overall trial start date
22/04/1994
Overall trial end date
01/01/1998
Reason abandoned (if study stopped)
Eligibility
Participant 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)
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
800
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
22/04/1994
Recruitment end date
01/01/1998
Locations
Countries of recruitment
United Kingdom
Trial participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
Medical Research Council (MRC) (UK)
Sponsor details
20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list