Condition category
Cancer
Date applied
21/09/2000
Date assigned
21/09/2000
Last edited
12/04/2012
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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
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

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 measures

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

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 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 (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

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20855843

Publication citations

  1. 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.

Additional files

Editorial Notes