Condition category
Cancer
Date applied
13/03/2001
Date assigned
13/03/2001
Last edited
11/09/2007
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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

BS01

Study information

Scientific title

Acronym

Study hypothesis

1. To detect any effect of intravesical instillation of Thiotepa on the recurrence rate of superficial bladder cancer
2. To detect any extra effect of repeating instillations of Thiotepa at follow-up cytoscopy during the first year on the recurrence rate of superficial bladder cancer
3. To assess the effect of the presence of urothelial atypism or carcinoma in random biopsies on the recurrence rate of superficial bladder cancer

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

Condition

Cancer

Intervention

Intravesical thiotepa versus no intravesical chemotherapy

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Time to first superficial
2. Recurrence rate (number of positive cytoscopies per annum)
3. Failure-free survival rate

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/10/1981

Overall trial end date

31/12/1991

Reason abandoned

Eligibility

Participant inclusion criteria

1. Newly diagnosed superficial carcinoma of the bladder suitable for complete endoscopic resection
2. World Health Organisation (WHO) performance status 0-2
3. Expected survival at least 3 years
4. White count >3 x 10^9/L and platelets >100 x 10^9/L
5. No history of other malignant tumours
6. No untreated urinary tract infection

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

417

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/10/1981

Recruitment end date

31/12/1991

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 (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

Results on http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=8032829

Publication citations

  1. Results

    The effect of intravesical thiotepa on tumour recurrence after endoscopic treatment of newly diagnosed superficial bladder cancer. A further report with long-term follow-up of a Medical Research Council randomized trial. Medical Research Council Working Party on Urological Cancer, Subgroup on Superficial Bladder Cancer., Br J Urol, 1994, 73, 6, 632-638.

Additional files

Editorial Notes