Condition category
Cancer
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
05/06/2014
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

Mr R Hall

ORCID ID

Contact details

Freeman Hospital
Newcastle
NE7 7DN
United Kingdom

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 measures

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

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

http://www.doh.gov.uk

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes