JPRN-jRCT1031180233进行中（未招募）2 期
An exploratory phase II study of neoadjuvant bevacizumab and temozolomide chemotherapy for patients with newly diagnosed malignant glioma
Tamura Ryota0 个研究点目标入组 15 人开始时间: 2019年3月11日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 15
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
- 年龄范围
- >= 18age old 至 < 75age old（—）
- 性别
- All
入选标准
- •1) Newly diagnosed supratentorial malignant glioma primarily by imaging findings (ring enhancement and marked peritumoral edema on MRI) that is expected to gain a benefit from the neoadjuvant strategy (ex.hypervascular tumor, tumors with invasion into eloquent area).
- •2) Age between 18 to 75
- •3) Performance status (ECOG) of 0-2
- •4) Sufficient function of important organs.
- •Neu>1,500/mm3, Hb>8.0 g/dL, Plt>100,000/mm3, AST and ALT<3 times normal value, Bil<2.0 mg/dL, Cr<1.5 mg/dL, ECG: normal, lung function:SpO2>92%
- •5) Written informed consents are obtained.
排除标准
- •1) Uncontrollable severe infectious diseases.
- •2) Presence of active other cancers.
- •3) History of radiotherapy for head
- •4) Uncontrollable hypertention: SAP>150mmHg, DBP>100mmHg
- •5) Clinically significant cardiac disease (ex. congestive heart failure:NYHA gradeII)
- •6) Symptomatic myocardial infarction, cerebral infarction, deep vein thrombosis and pulmonary embolism within 6 months
- •7) Symptomatic intracerebral hemorrhage within 6 months
- •8) Hemoptysis within 28 days (CTCAE v4.0: grade2)
- •9) Bleeding diathesis and blood coagulation disorder
- •10) Unhealed scar and untreated bone fracture
- •11) Severe gastric ulcer
- •12) Pulmonary fibrosis and interstitial pneumonia
- •13) Pregnancy or lactation. Patients hope pregnancy
- •14) Allergy for temozolomide or bevacizumab
- •15) Allergy for gadolinium
- •16) Judged as inappropriate for this study by doctors.
研究者
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