Condition category
Cancer
Date applied
06/04/2000
Date assigned
06/04/2000
Last edited
07/07/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Simon Clawson

ORCID ID

Contact details

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

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 measures

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

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 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

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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Additional files

Editorial Notes