|
ISRCTN
|
ISRCTN16638426
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
A Multicentre Randomised Feasibility Study of Adjuvant Chemotherapy (CT) following Radical Primary Treatment for Transitional Cell Carcinoma (TCC) of the Bladder
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
EMI Study
|
|
Study hypothesis
|
Not provided at time of registration
|
|
Ethics approval
|
Not provided at time of registration
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Cancer of bladder (advanced)
|
|
Participants - 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
|
|
Participants - exclusion criteria
|
Not provided at time of registration
|
|
Anticipated start date
|
01/01/2000
|
|
Anticipated end date
|
15/02/2002
|
|
Status of trial
|
Completed
|
|
Patient information material
|
|
|
Target number of participants
|
Not provided at time of registration
|
|
Interventions
|
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
|
|
Primary outcome measure(s)
|
Not provided at time of registration
|
|
Secondary outcome measure(s)
|
Not provided at time of registration
|
|
Sources of funding
|
Northern Research and Development (UK)
|
|
Trial website
|
|
|
Publications
|
ReFeR results in http://www.refer.nhs.uk/ViewRecord.asp?ID=1138
|
|
Contact name
|
Dr
-
-
|
|
Address
|
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
|
|
City/town
|
London
|
|
Zip/Postcode
|
NW1 2DA
|
|
Country
|
United Kingdom
|
|
Sponsor
|
Northern Research and Development (UK)
|
|
Address
|
-
|
|
City/town
|
Durham
|
|
Zip/Postcode
|
-
|
|
Country
|
United Kingdom
|
|
Date applied
|
19/08/2002
|
|
Last edited
|
17/12/2007
|
|
Date ISRCTN assigned
|
19/08/2002
|
