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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
ReFeR results in http://www.refer.nhs.uk/ViewRecord.asp?ID=1138