Grade III (anaplastic astrocytoma) or grade IV (glioblastoma multiforme) tumours Cancer Malignant neoplasm of brain
Conditions
Interventions
Patients will be randomised to receive either
1. Conventional radiotherapy and temozolomide:
60 Gy radiotherapy is administered in 2 Gy fractions over 6 weeks, concomitantly with daily doses of temozo
Sponsors
Nordic Clinical Brain Tumour Study Group (Sweden)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Written informed consent 2. Histologically proven astrocytic glioma (grade III: AA or grade IV: GBM) 3. Age 18 - 60 years 4. Performance status WHO 0-2 5. Life expectancy > 3 months 6. Normal organ function, except if abnormal due to tumour involvement as indicated by: 6.1. Platelet count (TPK) 90 g/L 6.3. Neutrophils: < 1.5 x 10^3/mm3 or LPK < 3.0 x 10^9/L 6.4. Serum creatinine and bilirubin < 1.5 times the upper limit of normal (ULN) 6.5. Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) < 3 x ULN 7. Men and women of child bearing potential must be using adequate contraception
Exclusion criteria
Exclusion criteria: 1. Prior chemotherapy or radiotherapy for malignant glioma 2. Any other active malignancies within the last 5 years, except adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ 3. Pregnancy or breast feeding 4. Any condition (medical, social, psychological) which would prevent adequate information and follow up
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Safety, all adverse events are collected 2. Quality of Life (QoL), evaluated by the EORTC QLQ-30 before start of treatment, then 12 and 24 months after start of treatment. | — |
Countries
Denmark, Finland, Norway, Sweden
Outcome results
None listed