Temodal Capsule All-Case-Registered Surveillance (Designated Drug Use Investigation) - Evaluation of The Safety and Efficacy of Temodal in Patients With Newly Diagnosed Malignant Glioma (Concomitant With Radiotherapy and Then as Monotherapy) and Relapsed Malignant Glioma (as Monotherapy)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,804
- 主要终点
- Safety: observation of hematology, biochemistry, and adverse events (AEs); evaluation of details of occurrence of AEs and unexpected serious AEs, and evaluation of presence or absence of secondary malignancies and causal relationship with temozolomide.
研究概览
简要总结
The purpose of this study is to confirm the safety and efficacy of temozolomide in patients with newly diagnosed malignant glioma (concomitant with radiotherapy and then as monotherapy) and relapsed malignant glioma (as monotherapy) when used in the daily medical practices.
Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.
详细描述
Patients are invited to participate in the study.
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
- •All patients treated with temozolomide for newly diagnosed malignant glioma (concomitant with radiotherapy and then as monotherapy) and relapsed malignant glioma (as monotherapy).
排除标准
- •Patients with a history of hypersensitivity to temozolomide or dacarbazine.
- •Pregnant women and women who may be pregnant.
研究组 & 干预措施
Newly diagnosed patients
Patients treated with temozolomide for newly diagnosed malignant glioma
干预措施: Temozolomide (for newly diagnosed malignant glioma) (Drug)
Newly diagnosed patients
Patients treated with temozolomide for newly diagnosed malignant glioma
干预措施: Radiotherapy (for patients with newly diagnosed malignant glioma) (Radiation)
Relapsed patients
Patients treated with temozolomide for relapsed malignant glioma
干预措施: Temozolomide (for relapsed malignant glioma) (Drug)
Newly diagnosed anaplastic astrocytoma patients
Patients treated with temozolomide for newly diagnosed anaplastic astrocytoma
干预措施: Temozolomide (for newly diagnosed malignant glioma) (Drug)
Newly diagnosed anaplastic astrocytoma patients
Patients treated with temozolomide for newly diagnosed anaplastic astrocytoma
干预措施: Radiotherapy (for patients with newly diagnosed malignant glioma) (Radiation)
结局指标
主要结局
Safety: observation of hematology, biochemistry, and adverse events (AEs); evaluation of details of occurrence of AEs and unexpected serious AEs, and evaluation of presence or absence of secondary malignancies and causal relationship with temozolomide.
时间窗: AEs during treatment with temozolomide, serious AEs occurring within 30 days after completion of treatment with temozolomide. Secondary malignancies will be monitored from the start of treatment with temozolomide to final outcome.
Efficacy in patients registered during Period 1, evaluated as Remarkably Effective, Moderately Effective, Stable Disease, Progression, or Not Evaluable, considering tumor responses, progression free survival, overall survival, among other factors.
时间窗: One year after start of temozolomide treatment.
Efficacy in all newly diagnosed anaplastic astrocytoma patients:, evaluated as 5 year survival rate and overall survival.
时间窗: From the start of treatment with temozolomide to final outcome.
次要结局
未报告次要终点