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

ISRCTN	ISRCTN36343644
DOI	https://doi.org/10.1186/ISRCTN36343644
Secondary identifying numbers	0062/WASH/2000

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Mr Tim O'Brien
Scientific

Department of Urology
1st floor Thomas Guy House
Guy's Hospital
St Thomas Street
London
SE1 9RT
United Kingdom

Phone	+44 (0)207 1886796
Email	tim.obrien@gstt.nhs.uk

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Prevention
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study acronym	ODMIT-C
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Upper tract TCC bladder
Intervention	Intravesical instillation of Mitomycin-C post operatively versus no Mitomycin-C
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	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 study start date	20/07/2000
Completion date	01/12/2007

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	268
Key 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)
Key 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
Date of first enrolment	20/07/2000
Date of final enrolment	01/12/2007

Guy's Hospital

London
SE1 9RT
United Kingdom

Sussex NHS Research Consortium (UK)
Government

Research Department
Worthing Hospital
Lyndhurst Road
Worthing
BN11 2DH
United Kingdom

Phone	+44 (0)1903 285224
Email	john.sitzia@wash.nhs.uk

Charity

Guy's and St. Thomas' Charity (UK)
Private sector organisation / Trusts, charities, foundations (both public and private)

Alternative name(s): Guy's and St Thomas' Charity, Guy's and St Thomas' Foundation, GSTTFoundation
Location: United Kingdom

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Plain English results				No	Yes
Results article	results	01/10/2011		Yes	No

17/10/2018: Cancer Research UK lay results summary link added to Results (plain English)