Contact information
Type
Scientific
Primary contact
Miss Sally Stenning
ORCID ID
Contact details
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
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br12@ctu.mrc.ac.uk
Additional identifiers
EudraCT number
2005-004622-24
ClinicalTrials.gov number
NCT00052455
Protocol/serial number
E164/47
Study information
Scientific title
A prospective randomised trial comparing temozolomide with standard nitrosourea-based chemotherapy (PCV [procarbazine, CCNU, vincristine]/BCNU [bis-chloronitrosourea]) in the treatment of recurrent WHO astrocytic tumours grades III and IV (anaplastic astrocytoma and glioblastoma multiforme)
Acronym
BR12
Study hypothesis
BR12 is a randomised trial which compares standard PCV chemotherapy with two temozolomide schedules in patients with histologically confirmed recurrent World Health Organisation (WHO) Grade III or IV astrocytic tumour who have had primary radiotherapy (but no prior chemotherapy).
More details can be found at: http://www.ctu.mrc.ac.uk/research_areas/study_details.aspx?s=7
Ethics approval
No ethics information required at time of registration.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Astrocytic tumours (anaplastic astrocytoma and glioblastoma multiforme)
Intervention
1. Temozolomide according to one of two schedules:
a. Temozolomide, 200 mg/m^2 orally (po) days one to five
b. Temozolomide, 100 mg/m^2 po days one to 21
2. PCV chemotherapy (CCNU 100 mg/m^2 po day one, Procarbazine 100 mg/m^2 po days one to ten, Vincristine 1.5 mg/m^2 (max 2 mg) intravenous (iv) day one)
Intervention type
Drug
Phase
Not Specified
Drug names
Procarbazine, CCNU, vincristine, bis-chloronitrosourea, temozolomide
Primary outcome measure
The primary objective of the trial is to evaluate, in a group of patients representative of those who are considered for chemotherapy outside of trials, the potential benefit of temozolomide compared to PCV with respect to survival in patients with recurrent malignant glioma.
Secondary outcome measures
In addition, the treatments will be compared with respect to the following secondary outcome measures: survival free from progression (confirmed radiologically), and health-related quality of life. A further objective is to evaluate the comparative efficacy (progression-free survival) and toxicity of the two different temozolomide schedules.
Overall trial start date
03/01/2003
Overall trial end date
01/01/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients with histologically verified anaplastic astrocytoma, glioblastoma multiforme or gliosarcoma (WHO grade III/IV at diagnosis or relapse) who have undergone primary treatment which must include radiotherapy
2. Evidence of first progression confirmed by imaging (Computed Tomography [CT] or Magnetic Resonance Imaging [MRI])
3. Evaluable enhancing recurrent tumour on contrast enhanced MRI/CT scan (within 14 days prior to start of treatment)
4. Life expectancy more than or equal to one month (based on age, performance status)
5. Considered fit for chemotherapy
6. More than or equal to two months from completion of radiotherapy
7. No previous chemotherapy, radiosurgery or interstitial radiotherapy (brachytherapy) for glioma; debulking surgery on relapse is permissible
8. Adequate hepatic, renal and haematological function (within 14 days prior to entry). Absolute Neutrophil Count (ANC) more than or equal to 1500/mm^3; platelet count more than or equal to 100,000/mm^3; Blood Urea Nitrogen (BUN) and serum creatinine less than 1.5 x Upper Limit of local laboratory Normal range (ULN); Total and direct serum bilirubin less than 1.5 x ULN; Serum Glutamic-Oxaloacetic Transaminase (SGOT) or Serum Glutamic Pyruvic Transaminase (SGPT) less than 3 x ULN; Alkaline phosphatase less than 2 x ULN
9. Written informed consent given
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
500
Participant exclusion criteria
Age less than 18 years
WHO performance status grade 4
Previous recurrence
Pregnancy, breast feeding, patient or partner not using adequate contraception
Concomitant serious illness
Patients diagnosed with Oligodendroglioma
Recruitment start date
03/01/2003
Recruitment end date
01/01/2008
Locations
Countries of recruitment
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 (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/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
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20855843
Publication citations
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Results
Brada M, Stenning S, Gabe R, Thompson LC, Levy D, Rampling R, Erridge S, Saran F, Gattamaneni R, Hopkins K, Beall S, Collins VP, Lee SM, Temozolomide versus procarbazine, lomustine, and vincristine in recurrent high-grade glioma., J. Clin. Oncol., 2010, 28, 30, 4601-4608, doi: 10.1200/JCO.2009.27.1932.