|
ISRCTN
|
ISRCTN83176944
|
|
DOI
|
10.1186/ISRCTN83176944
|
|
ClinicalTrials.gov identifier
|
NCT00052455
|
|
EudraCT number
|
2005-004622-24
|
|
Public 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)
|
|
Scientific title
|
|
|
Acronym
|
BR12
|
|
Serial number at source
|
E164/47
|
|
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
|
|
Lay summary
|
http://cancerhelp.cancerresearchuk.org/trials/a-trial-looking-at-temozolomide-and-pcv-for-people-with-glioma-that-has-come-back-after-treatment
|
|
Ethics approval
|
No ethics information required at time of registration.
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Astrocytic tumours (anaplastic astrocytoma and glioblastoma multiforme)
|
|
Participants - 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
|
|
Participants - 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
|
|
Anticipated start date
|
03/01/2003
|
|
Anticipated end date
|
01/01/2008
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
500
|
|
Interventions
|
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)
|
|
Primary outcome measure(s)
|
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 measure(s)
|
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.
|
|
Sources of funding
|
Medical Research Council (UK)
|
|
Trial website
|
http://www.ctu.mrc.ac.uk/studies/BR12.asp
|
|
Publications
|
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20855843
|
|
Contact name
|
Miss
Sally
Stenning
|
|
Address
|
MRC Clinical Trials Unit
222 Euston Road
|
|
City/town
|
London
|
|
Zip/Postcode
|
NW1 2DA
|
|
Country
|
United Kingdom
|
|
Email
|
br12@ctu.mrc.ac.uk
|
|
Sponsor
|
Medical Research Council (MRC) (UK)
|
|
Address
|
20 Park Crescent
|
|
City/town
|
London
|
|
Zip/Postcode
|
W1B 1AL
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)20 7636 5422
|
|
Fax
|
+44 (0)20 7436 6179
|
|
Email
|
clinical.trial@headoffice.mrc.ac.uk
|
|
Sponsor website:
|
http://www.mrc.ac.uk
|
|
Date applied
|
21/09/2000
|
|
Last edited
|
12/04/2012
|
|
Date ISRCTN assigned
|
21/09/2000
|
