A randomised trial of epirubicin versus mitomycin C at the time of first recurrence in superficial bladder cancer
ISRCTN | ISRCTN77353795 |
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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
Scientific
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
Study design | Randomised controlled trial |
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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 | 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 |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | Epirubicin versus mitomycin C |
Primary outcome measure | Local recurrence, time to progression, metastases, morbidity |
Secondary outcome measures | Not provided at time of registration |
Overall study start date | 22/04/1994 |
Completion date | 01/01/1998 |
Eligibility
Participant type(s) | Patient |
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Age group | Not Specified |
Sex | Not Specified |
Target number of participants | 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Sponsor information
Medical Research Council (MRC) (UK)
Research council
Research council
20 Park Crescent
London
W1B 1AL
United Kingdom
Phone | +44 (0)20 7636 5422 |
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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
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 | |
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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 |
Editorial Notes
13/02/2018: No publications found in PubMed, study status unverified
30/11/2015: No publications found in PubMed.