A randomised study of radiotherapy and concomitant Temodal® (temozolomide) or neoadjuvant chemotherapy followed by radiotherapy and concomitant Temodal® in patients with high grade glioma

Completed

• Conditions: Grade III (anaplastic astrocytoma) or grade IV (glioblastoma multiforme) tumours; Cancer; Malignant neoplasm of brain

• Registration Number: ISRCTN45209900
• Lead Sponsor: ordic Clinical Brain Tumour Study Group (Sweden)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09-23
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 143

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)
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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified