NCT00753246已完成3 期
Phase-III Study of Standard Radiotherapy Plus Concomitant and Adjuvant OSAG 101 (Theraloc®) Plus Temozolomide vs. Standard Radiotherapy Plus Concomitant and Adjuvant Temozolomide in Patient With Newly Diagnosed, Histologically Confirmed Glioblastoma Multiforme Grade IV
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Progression-free interval determined by MRI
研究概览
简要总结
Determination of efficiency of nimotuzumab in adults with glioblastoma multiforma
详细描述
The objective of the present study is a comparison of treatment of patients with newly diagnosed glioblastoma multiforme grade IV. Patients will be randomized in one of two arms when included. Patients randomly assigned to arm A will receive Nimotuzumab (OSAG 101) plus Temozolomide concomitant with standard radiotherapy. Patients randomised in arm B will receive standard radiotherapy plus Temozolomide treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient signed informed consent
- •Newly diagnosed, histologically confirmed glioblastoma multiforme grade IV
- •Condition is measurable by MRI in at least one dimension
- •Age 18-70
- •Karnofsky-Index > 40
- •Treatment in a study center
- •Female patients with a childbearing potential must have a negative pregnancy test within one week before inclusion in the trial. Those female and male patients admitted in the study must use a reliable method of contraception.
- •Adequate haematological, renal and hepatic function:
- •Leucocytes >2.0x10^9/l
- •Hb> 10g/dl
- •Billirubin total < 2.5x upper limit of normal (ULN)
- •Creatinin i.S. < 1.5x ULN
- •AST (GOT)/ALT (GPT) < 5x ULN
排除标准
- •Patients with history of anaphylactic reaction to murine or humanized antibody
- •Patients with evidence second malignancy
- •Patients who are pregnant or patients who refused adequate contraceptive precaution (female and male) during the trial
- •Pregnancy and lactation
- •Other conditions considered by investigators as sound reasons for disqualification from enrolment into the study such as: potential non compliance with protocol requirement
- •No MRI for tumour evaluation
研究组 & 干预措施
Arm B
Placebo Comparator
adults with TMZ, RT
干预措施: nimotuzumab (Drug)
Arm A
Experimental
adults with TMZ, RT, nimotuzumab
干预措施: nimotuzumab (Drug)
结局指标
主要结局
Progression-free interval determined by MRI
时间窗: week 12, 24, 36, 52
次要结局
- Overall survival Time to reintervention Response rate according to RECIST criteria Toxicity according to CTC criteria Symptom control Quality of life(week 12, 24, 36, 52)
研究者
研究点 (1)
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