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 number | NCT00002840 |
| Secondary identifying numbers | S200/1233 BR11 |
- 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
Scientific
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
| none@provided.com |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | lomustine, procarbazine, vincristine |
| Primary outcome measure | Survival |
| Secondary outcome measures | Progression-free survival, quality of life including neurotoxicity and neuropsychological impairments |
| Overall study start date | 01/01/1999 |
| Completion date | 01/03/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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
- Austria
- Belgium
- England
- Finland
- France
- Germany
- Hungary
- Italy
- Netherlands
- Portugal
- Sweden
- Switzerland
- United Kingdom
Study participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Sponsor information
Medical Research Council (MRC) (UK)
Research council
Research council
20 Park Crescent
London
W1B 1AL
United Kingdom
| Phone | +44 (0)20 7636 5422 |
|---|---|
| clinical.trial@headoffice.mrc.ac.uk | |
| Website | http://www.mrc.ac.uk |
Funders
Funder type
Research council
Medical Research Council (MRC) (UK)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 | |
| 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.
