Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
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
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.
Ethics approval
The Linköping Ethics Committee approved in April 1999 (ref: Dnr 99086)
Study design
Multicentre open label randomised active controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet
Condition
Malignant glioma, grade 3-4 or 4
Intervention
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)
Intervention type
Drug
Phase
Not Specified
Drug names
Temozolomide (Temodal®) (TMZ)
Primary outcome measure
1. Survival
Secondary outcome measures
1. Quality of Life
2. Symptom control
3. Safety
4. Health resource utilization
Overall trial start date
01/02/2000
Overall trial end date
31/12/2009
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
Planned 480, stopped at 342
Participant 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
Recruitment start date
01/02/2000
Recruitment end date
31/12/2009
Locations
Countries of recruitment
Austria, Denmark, France, Norway, Sweden, Switzerland, Turkey
Trial participating centre
Unit of Advanced Palliative Home Care
Linköping
581 85
Sweden
Funders
Funder type
Other
Funder name
Nordic Clinical Brain Tumor Study group (Sweden)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
Basic results (scientific)
Publication list
1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22877848
Publication citations
-
Results
Malmström A, Grønberg BH, Marosi C, Stupp R, Frappaz D, Schultz H, Abacioglu U, Tavelin B, Lhermitte B, Hegi ME, Rosell J, Henriksson R, , Temozolomide versus standard 6-week radiotherapy versus hypofractionated radiotherapy in patients older than 60 years with glioblastoma: the Nordic randomised, phase 3 trial., Lancet Oncol., 2012, 13, 9, 916-926, doi: 10.1016/S1470-2045(12)70265-6.