Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
BA06
Study information
Scientific title
Acronym
Study hypothesis
1. To determine the survival advantage of the addition of three cycles of cisplatin, methotrexate and vinblastine (CMV) chemotherapy prior to definitive radiotherapy and/or cystectomy
2. To determine the morbidity and mortality of definitive treatment together with any additional toxicity arising from CMV chemotherapy
3. To determine the prognostic significance of downstaging to T0 following CMV chemotherapy
Collaboration with the European Organization for Research and Treatment of Cancer (EORTC), Australian Bladder Cancer Study Group, Norwegian Bladder Cancer Study Group, Club Urologico Espanol de Tratamiento Group, Finnbladder and National Cancer Institute, Canada.
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
Bladder cancer
Intervention
Primary chemotherapy in T2 (G3), T3 and T4a; N0 or NX; M0 TCC of the bladder
Intervention type
Drug
Phase
Phase III
Drug names
Chemotherapy
Primary outcome measure
Survival
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/12/1989
Overall trial end date
10/07/1995
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Histologically proven TCC of the bladder with biopsy-proven muscle invasion
2. Tumours considered curable (less than or equal to 7 cm)
3. GFK ≥50 ml/min (Cockcroft)
4. White blood count (WBC) >3.5 x 10^9/L and platelet count >100 x 10^9/L
Participant type
Patient
Age group
Not Specified
Gender
Both
Target number of participants
915 required, 975 entered
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/12/1989
Recruitment end date
10/07/1995
Locations
Countries of recruitment
United Kingdom
Trial participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
Medical Research Council (MRC) (UK)
Sponsor details
20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
National government
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
Basic results (scientific)
Publication list
1999 results on http://www.ncbi.nlm.nih.gov/pubmed/10470696
Hall RR, on behalf of the International Collaboration of the MRC Advanced Bladder Cancer Group. Updated results of a randomised control trial of neo-adjuvant cisplatin(C) methotrexate(M) and Vinblatine(V) Chemotherapy for muscle-invasive bladder cancer. Proceedings of ASCO, Vol 21, Abstract 710, 2002.
Publication citations
-
Results
Neoadjuvant cisplatin, methotrexate, and vinblastine chemotherapy for muscle-invasive bladder cancer: a randomised controlled trial. International collaboration of trialists., Lancet, 1999, 354, 9178, 533-540.