Condition category
Cancer
Date applied
13/03/2001
Date assigned
13/03/2001
Last edited
17/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Danielle Andrews

ORCID ID

Contact details

MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
+44 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

BS04

Study information

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

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Bladder cancer

Intervention

Epodyl or mitomycin C
Follow-up: 3 monthly for 1st year, 6 monthly for 2nd year, annually thereafter.

Intervention type

Drug

Phase

Not Specified

Drug names

epodyl or mitomycin C

Primary outcome measures

Recurrence free survival

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/07/1987

Overall trial end date

01/12/1995

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

1000

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/07/1987

Recruitment end date

01/12/1995

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 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

17/11/2015: No publications found on PubMed.