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 (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 (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
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
-
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.