Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
SUPBLACAN
Study information
Scientific title
Acronym
Study hypothesis
1. To conduct an audit of a new programme of cystoscopic follow-up for patients with Ta. T1 bladder carcinoma.
2. To conduct a randomised comparison of:
2.1. Mitocytin-C versus epirubicin as single intravesical instillations at the time of diagnosis to evaluate relative efficacy in prevention of recurrent bladder cancer
2.2. A single instillation of intravesical chemotherapy (MMC or Epi) versus five instillations (to be given at the time of each follow-up cystoscopy for 1 year) to determine the relative efficacy in reducing tumour recurrence in medium risk Ta.T1 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
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Cancer (neoplasms): Bladder (superficial)
Intervention
Not provided at time of registration
Intervention type
Drug
Phase
Not Applicable
Drug names
Mitocytin-C versus Epirubicin
Primary outcome measure
1.1 Number of unplanned incidents (return with symptoms, need for unscheduled cystoscopies or tumour resections).
1.2 Tumour recurrence rate and number of patients progressing to muscle invasion at 2 years.
iii. Inter-hospital variation of type of cystoscopy, anaesthetic, out-patient, day case, in-patient mix and cost of same.
2. Recurrence rate and progression to muscle invasion at 2 years.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
16/05/1994
Overall trial end date
15/05/1997
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Not provided at time of registration
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
16/05/1994
Recruitment end date
15/05/1997
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Freeman Hospital
Newcastle
NE7 7DN
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive Northern and Yorkshire (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
Basic results (scientific)
Publication list