ISRCTN45209900已完成不适用
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 个研究点目标入组 143 人开始时间: 2010年9月23日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 143
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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
排除标准
- •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
研究者
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