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ISRCTN
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ISRCTN81470623
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ClinicalTrials.gov identifier
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Public title
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A randomised study of two schedules of radiotherapy or chemotherapy in elderly patients with high grade glioma
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Scientific title
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A multicentre randomised active controlled study comparing two schedules of radiotherapy or chemotherapy in elderly patients with high grade glioma
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Acronym
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Temodal elderly
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Serial number at source
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N/A
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Study hypothesis
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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.
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Lay summary
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Ethics approval
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The Linköping Ethics Committee approved in April 1999 (ref: Dnr 99086)
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Study design
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Multicentre open label randomised active controlled parallel group trial
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Countries of recruitment
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Austria, Denmark, France, Norway, Sweden, Switzerland, Turkey
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Disease/condition/study domain
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Malignant glioma, grade 3-4 or 4
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/02/2000
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Anticipated end date
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31/12/2009
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use contact details below to request a patient information sheet
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Target number of participants
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Planned 480, stopped at 342
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Interventions
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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)
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Primary outcome measure(s)
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1. Survival
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Secondary outcome measure(s)
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1. Quality of Life
2. Symptom control
3. Safety
4. Health resource utilization
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Sources of funding
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Nordic Clinical Brain Tumor Study group (Sweden)
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Trial website
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Publications
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Contact name
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Dr
Annika
Malmström
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Address
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Unit of Advanced Palliative Home Care
(Linköpings Avancerad Hemsjukvård [LAH])
Linköping Regional Hospital (Regionsjukhuset i Linköping)
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City/town
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Linköping
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Zip/Postcode
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581 85
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Country
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Sweden
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Sponsor
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Nordic Clinical Brain Tumor Study group (Sweden)
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Address
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c/o Prof Roger Henriksson
Radiumhemmet
Karolinska Hospital in Solna
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City/town
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Stockholm
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Zip/Postcode
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17176
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Country
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Sweden
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Date applied
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12/02/2010
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Last edited
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03/03/2010
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Date ISRCTN assigned
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03/03/2010
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