EUCTR2004-003896-35-AT进行中（未招募）1 期
Phase I/II study on concomitant and adjuvant Temozolomide and Radiotherapy with or without PTK787/ZK222584 in newly diagnosed GBM
European Organisation for Research and Treatment of Cancer0 个研究点目标入组 220 人开始时间: 2006年1月24日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 220
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
- •? Histologically proven newly diagnosed GBM (according to local pathologist)
- •amenable to concomitant and adjuvant temozolomide treatment by investigator's
- •assessment.
- •? Interval between first surgery/biopsy and start of radiotherapy less than 6 weeks
- •(42 days) and interval from the last surgical procedure and the start of radiotherapy
- •more than 8 days (to allow healing prior to start of radiotherapy and adjuvant
- •? Start of radiotherapy within 8 days of randomization
- •? No prior chemotherapy, radiotherapy or prior anti-VEGF therapy.
- •? Patients should not be receiving EIADs. Patients under EIADS should be switched
- •to no EIADs prior to study entry (refer to chapter 5.7).
- •? All patients (male and female) must use effective contraception if of reproductive
- •potential. Females must not be pregnant or lactating.
- •? ECOG Performance status < 2.
- •? Aged = 18 years and < 70 years.
- •? Patients must be on a stable or decreasing dose of corticosteroids for at least two
- •? Normal haematological functions: neutrophils superior or equal to 1.5*109 cells/l,
- •platelets superior or equal to 100*109 cells/l.
- •? Normal liver functions: bilirubin < 1.5 times the upper limit of the normal range;
- •alkaline phosphatase and transaminases inferior to 2.5 the upper limit of the normal
- •? Serum creatinine lower than or equal to 150 µmol/l (< 1.7mg/dl).
- •? Clinically normal cardiac function without history of ischaemic heart disease in the
- •past 6 months with normal 12 lead ECG and absence of uncontrolled cardiac
- •arrythmias. Patients must not have history of congenital long QT syndrome or a
- •baseline 12-lead ECG QTc of >450msec in males and >470msec in females. No
- •history of stroke.
- •? No previous or current malignancies at other sites with the exception of cone
- •biopsied carcinoma of the cervix and adequately treated basal or squamous cell
- •skin carcinoma.
- •? Absence of any unstable systemic diseases or active uncontrolled infections.
- •Absence of uncontrolled hypertension.
- •? No concomitant treatment with warfarine or other coumarine derivatives. No
- •concomitant treatment with other anti cancer agents and with any other
- •experimental treatment.
- •? Absence of any psychological, familial, sociological or geographical condition
- •potentially hampering compliance with the study protocol and follow-up schedule;
- •those conditions should be assessed with the patient before registration in the trial.
- •? Before patient registration/randomization, written informed consent must be given
- •according to ICH/GCP, and national/local regulations.
- •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
- 未提供
研究者
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3 期
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