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
Secondary identifying numbers BS07
Submission date
28/02/2001
Registration date
28/02/2001
Last edited
13/02/2018
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
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

Contact information

Dr Danielle Andrews
Scientific

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA randomised trial of epirubicin versus mitomycin C at the time of first recurrence in superficial bladder cancer
Study objectives1. 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) studiedBladder cancer
InterventionFirst randomisation is between irrigation of the bladder with glycine/saline and no irrigation.
The second randomisation is between Epodye and mitomycin C.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Epirubicin versus mitomycin C
Primary outcome measureLocal recurrence, time to progression, metastases, morbidity
Secondary outcome measuresNot provided at time of registration
Overall study start date22/04/1994
Completion date01/01/1998

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants800
Key inclusion criteria1. 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 criteriaNot provided at time of registration
Date of first enrolment22/04/1994
Date of final enrolment01/01/1998

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom

Sponsor information

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

Funders

Funder type

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

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

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