Condition category
Cancer
Date applied
28/02/2001
Date assigned
28/02/2001
Last edited
14/07/2014
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

BR04

Study information

Scientific title

Acronym

Study hypothesis

To assess the value of post-operative radiotherapy in the management of low grade (1 & 2) astrocytoma and oligodendroglioma.

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

Two groups - post-operative radiotherapy and no post-operative radiotherapy.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Survival time, Morbidity, Time to progression

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/08/1986

Overall trial end date

30/06/1996

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age 16-66
2. World Health Organisation (WHO) performance status 0-2
3. Neurosurgery within past 8 weeks
4. No previous malignancy
5. No previous treatment except surgery
6. Corticosteroids, anticonvulsants or diuretics
7. No condition likely to prejudice treatment or follow up

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

250

Participant exclusion criteria

History of cardiac disease

Recruitment start date

01/08/1986

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

2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16168780

Publication citations

  1. Results

    van den Bent MJ, Afra D, de Witte O, Ben Hassel M, Schraub S, Hoang-Xuan K, Malmström PO, Collette L, Piérart M, Mirimanoff R, Karim AB, , Long-term efficacy of early versus delayed radiotherapy for low-grade astrocytoma and oligodendroglioma in adults: the EORTC 22845 randomised trial., Lancet, 366, 9490, 985-990, doi: 10.1016/S0140-6736(05)67070-5.

Additional files

Editorial Notes