Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
30/05/2012
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

Dr - -

ORCID ID

Contact details

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

EMI Study

Study information

Scientific title

Acronym

Study hypothesis

Not provided at time of registration

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

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Cancer of bladder (advanced)

Intervention

Total Cystectomy or Radical RT +/- CT
CT: Methotrexate 30 mg/m^2 (days 1, 15, 22) Vinblastine 3 mg/m^2 (days 2, 15, 22) Adriamycin 30 mg/m2 (day 2) Cisplatin 70 mg/m2 (day 2) every 28 days, maximum of three cycles

Intervention type

Drug

Phase

Not Specified

Drug names

Methotrexate, vinblastine, adriamycin

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/2000

Overall trial end date

15/02/2002

Reason abandoned

Eligibility

Participant inclusion criteria

1. Histologically confirmed invasive TCC of the bladder
2. Stage T2, T3a, T3b, T4a, N0 or T(any), N1/N2
3. Patient has undergone a complete resection at cystectomy or has received radical radiotherapy with curative intent
4. Fit enough to undergo combination chemotherapy
5. Creatinine clearance >60ml/min within 10 weeks of primary treatment
6. Haematological counts within 4 weeks before randomisation: White Blood Count (WBC) >3x10^9/l Platelets >100 x10^9/l Haemoglobin >10g/dl
7. Patient must be able to commence CT within 12 weeks of completion of primary treatment
8. Written informed consent

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

01/01/2000

Recruitment end date

15/02/2002

Locations

Countries of recruitment

United Kingdom

Trial participating centre

UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom

Sponsor information

Organisation

Northern Research and Development (UK)

Sponsor details

-
Durham
-
United Kingdom

Sponsor type

Research organisation

Website

Funders

Funder type

Research organisation

Funder name

Northern Research and Development (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

ReFeR results in http://www.refer.nhs.uk/ViewRecord.asp?ID=1138

Publication citations

Additional files

Editorial Notes