Treatment of Primary Glioblastoma Multiforme With Cetuximab, Radiotherapy and Temozolomide (GERT) - Phase I/II Trial
试验速览
- 阶段
- 1 期
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Toxicity
研究概览
简要总结
GERT is a one-armed single-center phase I/II trial. In a first step, dose-escalation of TMZ from 50 mg/m2 to 75mg/m2 together with radiotherapy and cetuximab will be performed. Should safety be proven, the phase II trial will be initiated with the standard dose of 75mg/m2 of TMZ. Cetuximab will be applied in the standard application dose of 400mg/m2 in week 1, thereafter at a dose of 250mg/m2 weekly. A total of 46 patients will be included into this phase I/II trial.
Primary endpoints are feasibility and toxicity, secondary endpoints are overall and progression-free survival. An interim analysis will be performed after inclusion of 15 patients into the main study. Patients' enrolment will be performed over a period of 2 years. The observation time will end 2 years after inclusion of the last patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •>= 18 and < 70 years of age
- •Karnofsky Performance Score >= 60
- •histologically confirmed supratentorial GBM
- •interval between primary diagnosis and registration for the study < 4 weeks
- •patients will be included according to the incidental gender distribution for patients with GBM of ♀/♂ 2:3
- •adequate blood values (not older than 14 days prior to initiation of RCHT)
- •neutrophil count (ANC) ≥1500/mm3 or white blood cells (WBC) ≥2000/mm3
- •platelets ≥100.000/mm3
- •hemoglobin ≥10g/dL
- •BUN <1.5 times the upper range
- •Total and direct bilirubin <1.5times the upper laboratory limit
- •Adequate liver enzymes <3 times the upper laboratory limit
- •Life expectancy >12 weeks
- •Written informed consent
排除标准
- •refusal of the patients to take part in the study
- •previous radiotherapy of the brain or chemotherapy with DTIC or TMZ
- •known allergy against extrinsical proteins
- •previous chemotherapy or therapy with an EGFR-inhibitor
- •Previous antibody therapy
- •Patients who have not yet recovered from acute toxicities of prior therapies
- •Acute infections requiring systemic application of antibiotics
- •Frequent vomiting or a medical condition preventing the oral application of TMZ
- •Clinically active kidney- liver or cardiac disease
- •Known carcinoma < 5 years ago (excluding Carcinoma in situ of the cervix, basal cell carcinoma, squamous cell carcinoma of the skin)
- •Pregnant or lactating women
- •Participation in another clinical study
结局指标
主要结局
Toxicity
次要结局
- Overall survival