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ISRCTN
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ISRCTN32891249
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DOI
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10.1186/ISRCTN32891249
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ClinicalTrials.gov identifier
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NCT00002840
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EudraCT number
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Public title
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A randomised trial of adjuvant procarbazine, CCNU, vincristine chemotherapy in patients with highly anaplastic oligodendroglioma (BR11) - EORTC
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Scientific title
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Acronym
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BR11
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Serial number at source
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S200/1233 BR11
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Study hypothesis
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To determine the efficacy and safety of adjuvant PCV chemotherapy in patients with anaplastic oligodendroglioma following surgery and radiation therapy.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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International
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Disease/condition/study domain
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Brain tumour
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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Does not meet inclusion criteria
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Anticipated start date
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01/01/1999
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Anticipated end date
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01/03/2002
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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350
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Interventions
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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
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Primary outcome measure(s)
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Survival
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Secondary outcome measure(s)
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Progression-free survival, quality of life including neurotoxicity and neuropsychological impairments
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Sources of funding
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Medical Research Council (MRC) (UK)
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Trial website
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Publications
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1. 2006 results on http://www.ncbi.nlm.nih.gov/pubmed/16782911
2. 2007 results on http://www.ncbi.nlm.nih.gov/pubmed/18089866
3. 2007 results on http://www.ncbi.nlm.nih.gov/pubmed/18089867
4. 2009 results on http://www.ncbi.nlm.nih.gov/pubmed/19224764
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Contact name
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Dr
Simon
Clawson
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Address
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MRC Clinical Trials Unit
222 Euston Road
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City/town
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London
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Zip/Postcode
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NW1 2DA
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Country
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United Kingdom
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Email
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Sponsor
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Medical Research Council (MRC) (UK)
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Address
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20 Park Crescent
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City/town
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London
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Zip/Postcode
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W1B 1AL
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Country
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United Kingdom
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Tel
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+44 (0)20 7636 5422
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Fax
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+44 (0)20 7436 6179
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Email
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clinical.trial@headoffice.mrc.ac.uk
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Sponsor website:
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http://www.mrc.ac.uk
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Date applied
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06/04/2000
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Last edited
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01/07/2009
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Date ISRCTN assigned
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06/04/2000
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