Condition category
Cancer
Date applied
28/02/2001
Date assigned
28/02/2001
Last edited
12/04/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Hannah Brooks

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

BR05

Study information

Scientific title

Acronym

Study hypothesis

To assess whether the addition of chemotherapy to a standard radiotherapy regime influences the survival of adult patients with malignant glioma (astrocytomas grades 3 & 4) and to assess the ability of in vitro chemosensitivity testing to identify patients with a better prognosis.

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

Condition

Cancer

Intervention

1. One group receives chemotherapy added to a standard radiotherapy regimen
2. The other group receives none

Intervention type

Drug

Phase

Not Specified

Drug names

Chemotherapy

Primary outcome measures

Survival time

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/09/1988

Overall trial end date

30/06/1996

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age 18-69
2. No previous treatment except surgery, corticosteroids, anticonvulsants or diuretics
3. Entry within 6 weeks of surgery
4. Other malignancies
5. Fitness for treatment

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

600

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/09/1988

Recruitment end date

30/06/1996

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

2001 results in http://www.ncbi.nlm.nih.gov/pubmed/11208845

Publication citations

  1. Results

    Randomized trial of procarbazine, lomustine, and vincristine in the adjuvant treatment of high-grade astrocytoma: a Medical Research Council trial., J. Clin. Oncol., 2001, 19, 2, 509-518.

Additional files

Editorial Notes