A prospective randomised trial of resection versus biopsy in patients with malignant glioma

ISRCTN ISRCTN48935548
DOI https://doi.org/10.1186/ISRCTN48935548
Protocol serial number E164/45
Sponsor Medical Research Council (MRC) (UK)
Funder Medical Research Council (UK)
Submission date
21/09/2000
Registration date
21/09/2000
Last edited
16/08/2011
Recruitment status
Stopped
Overall study status
Stopped
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Miss Sally Stenning
Scientific

MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Email ss@ctu.mrc.ac.uk

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Scientific title
Study acronym-
Study objectivesThis trial will compare two treatments - radiotherapy or chemotherapy (using temozolomide) in patients for whom it is decided active treatment is needed. Patients entered onto the trial will be randomly selected to one of the two treatments available.
Ethics approval(s)Not provided at time of registration.
Health condition(s) or problem(s) studiedCancer
InterventionTrial stopped: Not submitted for funding
Intervention typeDrug
PhasePhase III
Drug / device / biological / vaccine name(s)Temozolomide
Primary outcome measure(s)

Not provided at time of registration.

Key secondary outcome measure(s)

Not provided at time of registration.

Completion date01/09/2005
Reason abandoned (if study stopped)Lack of funding

Eligibility

Participant type(s)Patient
Age groupAdult
SexAll
Key inclusion criteriaNot provided at time of registration.
Key exclusion criteriaNot provided at time of registration.
Date of first enrolment01/09/1999
Date of final enrolment01/09/2005

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan