Temodal (TMZ) in Concomitant Radiochemotherapy Followed by Sequential TMZ Chemotherapy in Newly Diagnosed Glioblastoma Multiforme Patients - an Observational Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 主要终点
- Safety: Number of Adverse Events in the Indicated Categories
研究概览
简要总结
The purpose of this program is to evaluate the safety, tolerability, and efficacy of the new concomitant and sequential temozolomide regimen in newly diagnosed Glioblastoma patients in a routine care setting.
详细描述
Participant sampling method: consecutive patient sampling.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed Glioblastoma multiforme
排除标准
- •History of hypersensitivity to temozolomide or its components, or to dacarbazine.
- •Women who are pregnant or breast-feeding.
- •Patients with severe myelosuppression.
研究组 & 干预措施
Patients
Participants with newly diagnosed Glioblastoma multiforme who were prescribed temozolomide and radiotherapy as standard care.
干预措施: Temozolomide (Drug)
Patients
Participants with newly diagnosed Glioblastoma multiforme who were prescribed temozolomide and radiotherapy as standard care.
干预措施: Radiotherapy (Radiation)
结局指标
主要结局
Safety: Number of Adverse Events in the Indicated Categories
时间窗: Weekly during the concomitant treatment phase, and then monthly during the monotherapy phase
Number of Participants Who Discontinued Due to Toxicity
时间窗: Weekly during the concomitant treatment phase, and then monthly during the monotherapy phase
次要结局
未报告次要终点