Plain English Summary
Trial website
Contact information
Type
Scientific
Primary contact
Mr Tim O'Brien
ORCID ID
Contact details
Department of Urology
1st floor Thomas Guy House
Guy's Hospital
St Thomas Street
London
SE1 9RT
United Kingdom
+44 (0)207 1886796
tim.obrien@gstt.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
0062/WASH/2000
Study information
Scientific title
A multicentre, prospective, randomised study of the value of a single dose of intravesical Mitomycin-C in preventing the development of bladder tumours following nephroureterectomy for transitional cell carcinoma (TCC) of the upper urinary tract
Acronym
ODMIT-C
Study hypothesis
The hypothesis is that a single dose of intravesical Mitomycin-C prevents tumour recurrence in the bladder following nephroureterectomy for a transitional cell carcinoma of the upper urinary tract.
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
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Upper tract TCC bladder
Intervention
Intravesical instillation of Mitomycin-C post operatively versus no Mitomycin-C
Intervention type
Drug
Phase
Not Applicable
Drug names
Mitomycin-C
Primary outcome measure
Incidence of tumour recurrence at 1 year post nephroureterectomy
Secondary outcome measures
To study the post surgical survival of these patients over five years.
Overall trial start date
20/07/2000
Overall trial end date
01/12/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. A new clinical diagnosis of a transitional cell tumour of the upper urinary tract above the intramural ureter
2. A negative cystoscopy for TCC bladder within one month of the nephroureterectomy
3. A nephroureterectomy that is planned to be performed in such a way that there is early distal ligation of the ureter prior to the mobilisation of the tumour. The intramural portion of the ureter may be resected prior to the open part of the operation, taken at the open operation with a cuff of bladder or everted at the end of the operation and resected endoscopically according to surgical preference.
4. Have a life expectancy of at least one year
5. Informed consent to participate (written and witnessed)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
268
Participant exclusion criteria
1. The histology of the upper tract tumour does not confirm a transitional cell carcinoma
2. Stage N1 or M1
3. Had additional systemic chemotherapy or additional intravesical Mitomycin-C at follow up cystoscopies
4. Existing or previous transitional cell carcinoma of bladder
5. Children, pregnant women excluded
6. Life expectancy less than one year
7. Known sensitivity to Mitomycin-C
Recruitment start date
20/07/2000
Recruitment end date
01/12/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Guy's Hospital
London
SE1 9RT
United Kingdom
Sponsor information
Organisation
Sussex NHS Research Consortium (UK)
Sponsor details
Research Department
Worthing Hospital
Lyndhurst Road
Worthing
BN11 2DH
United Kingdom
+44 (0)1903 285224
john.sitzia@wash.nhs.uk
Sponsor type
Government
Website
Funders
Funder type
Charity
Funder name
Guy's and St. Thomas' Charity (UK)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
Other non-profit organizations
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
Basic results (scientific)
Publication list
2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21684068