ISRCTN45209900
Completed
Not Applicable
A multicentre, phase III, randomised controlled trial of radiotherapy and concomitant Temodal® (temozolomide) or neoadjuvant chemotherapy followed by radiotherapy and concomitant Temodal® in patients with high grade glioma
ordic Clinical Brain Tumour Study Group (Sweden)0 sites143 target enrollmentSeptember 23, 2010
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Grade III (anaplastic astrocytoma) or grade IV (glioblastoma multiforme) tumours
- Sponsor
- ordic Clinical Brain Tumour Study Group (Sweden)
- Enrollment
- 143
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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) \< 100 x 10^9/L
- •6\.2\. Haemoglobin (Hb) \> 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)
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
Outcomes
Primary Outcomes
Not specified
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