Condition category
Cancer
Date applied
29/07/2005
Date assigned
02/09/2005
Last edited
20/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

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

2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21684068

Publication citations

Additional files

Editorial Notes