A randomised trial of adjuvant procarbazine, CCNU, vincristine chemotherapy in patients with highly anaplastic oligodendroglioma (BR11) - EORTC

ISRCTN	ISRCTN32891249
DOI	https://doi.org/10.1186/ISRCTN32891249
ClinicalTrials.gov (NCT)	NCT00002840
Protocol serial number	S200/1233 BR11
Sponsor	Medical Research Council (MRC) (UK)
Funder	Medical Research Council (MRC) (UK)

Submission date: 06/04/2000
Registration date: 06/04/2000
Last edited: 29/10/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Simon Clawson
Scientific

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

Email	none@provided.com

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A randomised trial of adjuvant procarbazine, CCNU, vincristine chemotherapy in patients with highly anaplastic oligodendroglioma (BR11) - EORTC
Study acronym	BR11
Study objectives	To determine the efficacy and safety of adjuvant PCV chemotherapy in patients with anaplastic oligodendroglioma following surgery and radiation therapy.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Brain tumour
Intervention	1. One group has surgery plus chemotheapy plus PCV chemotherapy (6 cycles of every 6 weeks, CCNU 110 mg/m^2 po day 1; Procarbazine 60 mg/m^2 po days 8-21; Vincristine 1.4 mg/m^2 iv on day 8 and day 29) 2. The other group has surgery and radiotherapy only
Intervention type	Drug
Phase	Phase III
Drug / device / biological / vaccine name(s)	lomustine, procarbazine, vincristine
Primary outcome measure(s)	Survival
Key secondary outcome measure(s)	Progression-free survival, quality of life including neurotoxicity and neuropsychological impairments
Completion date	01/03/2002

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	350
Total final enrolment	368
Key inclusion criteria	1. Newly diagnosed anaplastic oligodendroglioma, or oligoastrocytoma (with 25% or more oligodendral elements); including patients treated with surgery only for a low grade oligoastrocytoma or oligodendroglioma who are diagnosed with anaplastic tumour at the time of recurrence 2. At least three of five histologic anaplastic features: high cellularity, nuclear abnormalities, mitoses, endothelial abnormalities and necrosis, as diagnosed by the local pathologist
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	01/01/1999
Date of final enrolment	01/03/2002

Locations

Countries of recruitment

United Kingdom
England
Austria
Belgium
Finland
France
Germany
Hungary
Italy
Netherlands
Portugal
Sweden
Switzerland

Study participating centre

MRC Clinical Trials Unit

London
NW1 2DA
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	20/06/2006		Yes	No
Results article	results	20/12/2007		Yes	No
Results article	results	20/12/2007		Yes	No
Results article	results	01/12/2009		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Plain English results		05/05/2010	29/10/2021	No	Yes

Editorial Notes

29/10/2021: The following changes have been made:
1. The Cancer Research UK lay results summary has been added.
2. The total final enrolment number has been added.