EUCTR2011-000921-61-DE进行中（未招募）1 期
A phase I/II, randomized, open-label, multi-centre study of BIBF1120 +reirradiation (R-RT) versus reirradiation in the treatment of patients withfirst or second progression of glioblastoma - NOA-12: BIBF1120 and R-RT in glioblastoma
Ruprecht-Karls-University Heidelberg, Medical Faculty0 个研究点目标入组 92 人开始时间: 2011年11月17日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 92
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Male and female patients with a recurrence / progression of
- •glioblastoma either not being eligible for tumour resection or
- •having macroscopic residual tumor after resection of the
- •- Diagnosis of glioblastoma must be proven histologically and
- •progress must be documented by MRI. MRI images must not be
- •older than 2 weeks before first dosing/start of RT
- •- Not more than two prior therapy regimens including one or two
- •resections, one or two chemotherapies (one temozolomidecontaining concomitant to radiotherapy) and one radiotherapy (RT) for the brain tumor
- •- Previous irradiation therapy of the primary tumor with a maximal dose of 60 Gy; at least 8 months since the end of preirradiation
- •- Candidate for reirradiation with recurrent tumor visible on MRIT1 (Gd) and with the largest diameter measuring 1 cm to 5 cm
- •- Informed consent
- •- Age = 18 years, smoking or non-smoking, of any ethnic origin
- •- Karnofsky performance index (KPI) = 60%
- •- Neutrophile counts > 1500/µl / Platelet counts > 80.000/µl /
- •Haemoglobin > 10 g/dl / Serum creatinine < 1.5-fold upper normal range / Bilirubin, AST or ALT < 2,5-fold upper normal range unless attributed to anticonvulsants / Alkaline phosphatase < 2,5-fold upper normal range
- •- Adequate contraception
- •- If on steroids, stable or decreasing treatment with steroids within 5 days before treatment start
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- More than one RT of brain, prior first radiotherapy with more than 60 Gy
- •- Cumulative total dose on the optical chiasm >54 Gy for 2
- •Gy/fraction, a/ß=2
- •- Prior treatment with bevacizumab, iodine seeds and/or
- •brachytherapy
- •- Unable to undergo contrast-enhanced MRI
- •- Past medical history of diseases with poor prognosis according to the judgement of the Investigator, e.g. severe coronary heart
- •disease, severe diabetes, immune deficiency, residual deficits after
- •stroke, severe mental retardation
- •- HIV or hepatitis infection
- •- Pregnancy or breast feeding
- •- Treatment within any other clinical trial parallel to the treatment
- •phase of the current study or within 30 days before inclusion
- •- Known coronary artery disease, significant cardiac arrhythmias or severe congestive heart failure (NYHA class III – IV)
研究者
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