Condition category
Cancer
Date applied
13/03/2001
Date assigned
13/03/2001
Last edited
09/07/2014
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 Barbara Uscinska

ORCID ID

Contact details

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

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 measures

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

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 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

Results - basic reporting

Publication summary

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

  1. 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.

Additional files

Editorial Notes