A phase III study of primary chemotherapy in T2 (G3), T3 and T4a; N0 or NX; M0 transitional cell carcinoma (TCC) of the bladder

ISRCTN ISRCTN82694463
DOI https://doi.org/10.1186/ISRCTN82694463
Secondary identifying numbers BA06
Submission date
13/03/2001
Registration date
13/03/2001
Last edited
09/07/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Barbara Uscinska
Scientific

MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectives1. 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedBladder cancer
InterventionPrimary chemotherapy in T2 (G3), T3 and T4a; N0 or NX; M0 TCC of the bladder
Intervention typeDrug
Pharmaceutical study type(s)
PhasePhase III
Drug / device / biological / vaccine name(s)Chemotherapy
Primary outcome measureSurvival
Secondary outcome measuresNot provided at time of registration
Overall study start date01/12/1989
Completion date10/07/1995

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexBoth
Target number of participants915 required, 975 entered
Key inclusion criteria1. 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
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/12/1989
Date of final enrolment10/07/1995

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom

Sponsor information

Medical Research Council (MRC) (UK)
Research council

20 Park Crescent
London
W1B 1AL
United Kingdom

Phone +44 (0)20 7636 5422
Email clinical.trial@headoffice.mrc.ac.uk
Website http://www.mrc.ac.uk

Funders

Funder type

Research council

Medical Research Council (MRC) (UK)
Government organisation / National government
Alternative name(s)
Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 14/08/1999 Yes No