Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00002840
Protocol/serial number
S200/1233 BR11
Study information
Scientific title
Acronym
BR11
Study hypothesis
To determine the efficacy and safety of adjuvant PCV chemotherapy in patients with anaplastic oligodendroglioma following surgery and radiation therapy.
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
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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 names
lomustine, procarbazine, vincristine
Primary outcome measure
Survival
Secondary outcome measures
Progression-free survival, quality of life including neurotoxicity and neuropsychological impairments
Overall trial start date
01/01/1999
Overall trial end date
01/03/2002
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
350
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
01/01/1999
Recruitment end date
01/03/2002
Locations
Countries of recruitment
Austria, Belgium, Finland, France, Germany, Hungary, Italy, Netherlands, Portugal, Sweden, Switzerland, 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 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
National government
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
Basic results (scientific)
Publication list
2006 results on http://www.ncbi.nlm.nih.gov/pubmed/16782911
2007 results on http://www.ncbi.nlm.nih.gov/pubmed/18089866
2007 results on http://www.ncbi.nlm.nih.gov/pubmed/18089867
2009 results on http://www.ncbi.nlm.nih.gov/pubmed/19224764
Publication citations
-
Results
van den Bent MJ, Carpentier AF, Brandes AA, Sanson M, Taphoorn MJ, Bernsen HJ, Frenay M, Tijssen CC, Grisold W, Sipos L, Haaxma-Reiche H, Kros JM, van Kouwenhoven MC, Vecht CJ, Allgeier A, Lacombe D, Gorlia T, Adjuvant procarbazine, lomustine, and vincristine improves progression-free survival but not overall survival in newly diagnosed anaplastic oligodendrogliomas and oligoastrocytomas: a randomized European Organisation for Research and Treatment of Cancer phase III trial., J. Clin. Oncol., 2006, 24, 18, 2715-2722, doi: 10.1200/JCO.2005.04.6078.
-
Results
Taphoorn MJ, van den Bent MJ, Mauer ME, Coens C, Delattre JY, Brandes AA, Sillevis Smitt PA, Bernsen HJ, Frénay M, Tijssen CC, Lacombe D, Allgeier A, Bottomley A, , Health-related quality of life in patients treated for anaplastic oligodendroglioma with adjuvant chemotherapy: results of a European Organisation for Research and Treatment of Cancer randomized clinical trial., J. Clin. Oncol., 2007, 25, 36, 5723-5730, doi: 10.1200/JCO.2007.12.7514.
-
Results
Mauer ME, Taphoorn MJ, Bottomley A, Coens C, Efficace F, Sanson M, Brandes AA, van der Rijt CC, Bernsen HJ, Frénay M, Tijssen CC, Lacombe D, van den Bent MJ, , Prognostic value of health-related quality-of-life data in predicting survival in patients with anaplastic oligodendrogliomas, from a phase III EORTC brain cancer group study., J. Clin. Oncol., 2007, 25, 36, 5731-5737, doi: 10.1200/JCO.2007.11.1476.
-
Results
Kouwenhoven MC, Gorlia T, Kros JM, Ibdaih A, Brandes AA, Bromberg JE, Mokhtari K, van Duinen SG, Teepen JL, Wesseling P, Vandenbos F, Grisold W, Sipos L, Mirimanoff R, Vecht CJ, Allgeier A, Lacombe D, van den Bent MJ, Molecular analysis of anaplastic oligodendroglial tumors in a prospective randomized study: A report from EORTC study 26951., Neuro-oncology, 2009, 11, 6, 737-746, doi: 10.1215/15228517-2009-011.