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A randomised study of two schedules of radiotherapy or chemotherapy in elderly patients with high grade glioma
ISRCTN ISRCTN81470623
DOI 10.1186/ISRCTN81470623
ClinicalTrials.gov identifier
EudraCT number
Public title A randomised study of two schedules of radiotherapy or chemotherapy in elderly patients with high grade glioma
Scientific title A multicentre randomised active controlled study comparing two schedules of radiotherapy or chemotherapy in elderly patients with high grade glioma
Acronym Temodal elderly
Serial number at source N/A
Study hypothesis To compare conventional radiotherapy (RT) (2 Gy up to 60 Gy) to short term RT (3.4 Gy up to 34 Gy) or chemotherapy alone after surgery or biopsy.
Lay summary Not provided at time of registration
Ethics approval The Linköping Ethics Committee approved in April 1999 (ref: Dnr 99086)
Study design Multicentre open label randomised active controlled parallel group trial
Countries of recruitment Austria, Denmark, France, Norway, Sweden, Switzerland, Turkey
Disease/condition/study domain Malignant glioma, grade 3-4 or 4
Participants - inclusion criteria 1. Age > 60
2. Performance Status (PS) 0-2 according to the WHO definition. Patients with a general condition corresponding to WHO 0-2, but due to physical handicap are graded as PS 3 or 4 can also be included.
3. Patients with histologically/cytologically confirmed glioma grade 3-4 or 4
4. Expected to tolerate all three treatment options
5. Life expectancy of at least 3 months
6. General organ function allowing chemotherapy as indicated by:
6.1. Neutrophiles > 1.5 x 109/l
6.2. Platelets > 100 x 109/l
6.3. Haemoglobin > 10 g/dl (100g/l)
6.4. Serum creatinine and bilirubin < 1.5 times upper normal limit
6.5. Aspartate Aminotransferase (ASAT), alanine Aminotransferase (ALAT) < 3 times upper normal limit
7. No other medical condition likely to interfere with treatment or the assessment of its efficacy
8. Patient is on the lowest steroid dose, which gives optimal functional improvement
9. Written informed consent
Participants - exclusion criteria 1. Patients with other primary cancer, with the exception of radically treated squamous or basal cell carcinoma of the skin or other curatively treated malignancy without relapse 2 years after diagnosis
2. PS WHO grade 3-4, except for patients with a general condition corresponding to WHO 0-2, but due to physical handicap are graded as PS 3 or 4
3. Any other medical condition which, in the view of the investigator, is a contraindication to inclusion in the study
4. Chemotherapy, biological therapy, radiotherapy or immunotherapy given previously for brain tumour or within 3 years for other malignancy
5. Radiotherapy to the head, which would interfere with giving radiotherapy treatment for brain tumour
Anticipated start date 01/02/2000
Anticipated end date 31/12/2009
Status of trial Completed
Patient information material Not available in web format, please use contact details below to request a patient information sheet
Target number of participants Planned 480, stopped at 342
Interventions Patients were randomised to either
1. Standard RT (60 Gy in 2 Gy fractions over 6 weeks)
2. Hypofractionated RT (34 Gy in 3,4 Gy fractions over 2 weeks)
3. 6 cycles of chemotherapy with TMZ (200 mg/m2 day 1-5 every 28 days)
Primary outcome measure(s) 1. Survival
Secondary outcome measure(s) 1. Quality of Life
2. Symptom control
3. Safety
4. Health resource utilization
Sources of funding Nordic Clinical Brain Tumor Study group (Sweden)
Trial website
Publications 1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22877848
Contact name Dr  Annika  Malmström
  Address Unit of Advanced Palliative Home Care
(Linköpings Avancerad Hemsjukvård [LAH])
Linköping Regional Hospital (Regionsjukhuset i Linköping)
  City/town Linköping
  Zip/Postcode 581 85
  Country Sweden
Sponsor Nordic Clinical Brain Tumor Study group (Sweden)
  Address c/o Prof Roger Henriksson
Radiumhemmet
Karolinska Hospital in Solna
  City/town Stockholm
  Zip/Postcode 17176
  Country Sweden
Date applied 12/02/2010
Last edited 30/10/2012
Date ISRCTN assigned 03/03/2010
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