Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
15/10/2012
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 - -

ORCID ID

Contact details

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

BA07

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

Not specified

Trial type

Treatment

Patient information sheet

Condition

Bladder (advanced)

Intervention

Patients are randomised to one of two treatment arms:
1. Arm A: Chemotherapy with methotrexate and vinblastine to be repeated every 21 days for a maximum of six cycles.
2. Arm B: Chemotherapy with cisplatin, methotrexate and vinblastine to be repeated every 21 days for a maximum of six cycles.

Intervention type

Drug

Phase

Not Specified

Drug names

Methotrexate and Vinblastine with Cisplatin

Primary outcome measures

Not provided at time of registration.

Secondary outcome measures

Not provided at time of registration.

Overall trial start date

01/07/1990

Overall trial end date

31/07/1995

Reason abandoned

Eligibility

Participant inclusion criteria

1. Transitional cell carcinoma (which may contain elements of squamous or adenocarcinoma) arising from a primary at any site in the urinary tract, and in one of the following groups: Initial presentation with stage T4b disease only: Localised invasive pelvic relapse after definitive radiotherapy (when cystectomy not possible or refused): Metastatic disease at any site (patients with completely resected metastases, including those with pelvic nodes, are eligible)
2. Glomerular filtration rate of more than 50 ml/min. Patients with impaired urinary function secondary to ureteric obstruction may have this relieved with stents or ureterostomy. If renal function then recovers the patients will be eligible
3. Adequate haematological function
4. No previous systemic chemotherapy
5. No concomitant or previous malignancy other than basal cell carcinoma of the skin or carcinoma in situ of the cervix
6. No medical contraindications to treatment protocols

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

01/07/1990

Recruitment end date

31/07/1995

Locations

Countries of recruitment

United Kingdom

Trial participating centre

UKCCCR Register Co-ordinator
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

Government

Funder name

Medical Research Council (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

Publication citations

Additional files

Editorial Notes