Malignant glioma, grade 3-4 or 4 Cancer Malignant neoplasm of brain
Conditions
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
Sponsors
Nordic Clinical Brain Tumor Study group (Sweden)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Survival | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Quality of Life 2. Symptom control 3. Safety 4. Health resource utilization | — |
Countries
Austria, Denmark, France, Norway, Sweden, Switzerland, Turkey
Outcome results
None listed