JPRN-jRCTs031200438招募中2 期
Phase 2 study of temozolomide as monotherapy for elderly and temozolomide sensitive glioblastoma
Tateishi Kensuke0 个研究点目标入组 5 人开始时间: 2021年3月24日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 5
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
- >= 71age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1. Newly diagnosed histologically and genetically confirmed glioblastoma.
- •2. Registration should be completed by 28 days after surgery.
- •3. MGMT methylated.
- •4. Drug sensitivity assay indicating temozolomide sensitive.
- •5. More than 71 years old and KPS 50.
- •6. Adequate organ function indicated by all of the following.
- •1)neutrophil count more than 1,500/mm3
- •2)Platelet count more than100 thousands
- •3)AST, ALT less than 100IU/L
- •4)Total bilirubin less than 1.5mg/dL
- •5).Serum creatinine less than 1.5mg/dL
- •7. Regardless of the presence of mesurable lesions.
- •8. Written informed consent
排除标准
- •1. Active infection, or critical status for treatment.
- •2. Multiple primary cancers with disease-free period less than 5
- •years, except carcinoma in situ or intra mucosal disease cured
- •by local therapy.
- •3. Known hypersensitivity to temozolomide.
- •4. Patients with active hepatic disease.
- •5. Carmustine wafer (Gliadel).
- •6. Any prior chemotherapy, radiotherapy.
- •7. Attending physician has determined unsuitable to participate in the study.
研究者
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