Condition category
Cancer
Date applied
28/02/2001
Date assigned
28/02/2001
Last edited
29/07/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Miss Sally Stenning

ORCID ID

Contact details

MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
ss@ctu.mrc.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

BR06

Study information

Scientific title

Acronym

Study hypothesis

To evaluate the effect of CHOP chemotherapy on event-free and overall survival.

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

Group 1: radiotherapy alone (54 Gy total dose in 27 fractions)
Group 2: radiotherapy as above, followed after 4 weeks by six cycles of CHOP chemotherapy given at 3-week intervals (cyclophosphamide 750 mg/m^2 iv, adriamycin 50 mg/m^2 iv, vincristine 1.4 mg/m^2 iv (max 2 mg) and prednisolone (20 mg po tds for 5 days)

Intervention type

Drug

Phase

Not Specified

Drug names

CHOP chemotherapy

Primary outcome measures

Survival.

Secondary outcome measures

Event-free survival.

Overall trial start date

01/11/1988

Overall trial end date

01/10/1995

Reason abandoned

Slow accrual

Eligibility

Participant inclusion criteria

1. Pathologically proven primary cerebral lymphoma
2. Aged 18-75
3. No previous radiotherapy or chemotherapy
4. Adequate neurological, physical and mental function

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

Target: 90, accrued: 53

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/11/1988

Recruitment end date

01/10/1995

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

1. 1998 ASCO Annual Meeting abstract results in http://www.asco.org/portal/site/ASCO/menuitem.34d60f5624ba07fd506fe310ee37a01d/?vgnextoid=76f8201eb61a7010VgnVCM100000ed730ad1RCRD&vmview=abst_detail_view&confID=31&abstractID=13720
2. 2000 results in: GM Mead, NM Bleehen, A Gregor, J Bullimore, R Rampling, JT Roberts, M Glaser, P Lantos, JW Ironside, TH Moss, M Brada, JB Whaley and SP Stenning for the MRC Brain Tumour Working Party (2000). A Medical Research Council Randomised Trial in patients with primary cerebral non-Hodgkin lymphoma. Cancer 89(6): 1359-1370 in http://www.ncbi.nlm.nih.gov/pubmed/11002232

Publication citations

  1. Mead GM, Bleehen NM, Gregor A, Bullimore J, Shirley D, Rampling RP, Trevor J, Glaser MG, Lantos P, Ironside JW, Moss TH, Brada M, Whaley JB, Stenning SP, A medical research council randomized trial in patients with primary cerebral non-Hodgkin lymphoma: cerebral radiotherapy with and without cyclophosphamide, doxorubicin, vincristine, and prednisone chemotherapy., Cancer, 2000, 89, 6, 1359-1370.

Additional files

Editorial Notes