A Retrospective Clinical Study of Postoperative Concurrent Chemoradiotherapy Combined With Anti-angiogenic Drugs in the Treatment of Glioblastoma.
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Progression-Free-Survival(PFS)
研究概览
简要总结
Temozolomide (TMZ) is an oral chemotherapy drug. It is an alkylating agent used as a first-line treatment for glioblastoma. This methylation damages the DNA and triggers the death of tumor cells. According to the results of several clinical studies, TMZ synchronous plus radiotherapy and subsequent as adjuvant therapy can significantly improve the survival rate of newly diagnosed glioblastoma patients.
详细描述
Glioma is the highest incidence of the central nervous system tumor. Surgical treatment is one of the most important therapeutic methods in patients with glioblastoma. But since malignant glioma is a highly invasive tumor, the rate of surgery failure is . So the postoperative therapy shall be accompanied by radiotherapy. Since 1998, the clinical application of Temozolomide(TMZ) has brought hope for malignant glioma patients with its definite curative effect. According to the results of several clinical studies, TMZ synchronous plus radiotherapy and subsequent as adjuvant therapy can significantly improve the survival rate of newly diagnosed GBM patients and break the survival limit of malignant glioma patients. Besides, antiangiogenic therapy is also a choice for the treatment of glioblastoma patients. Vascular endothelial growth factor receptors (VEGFRs) inhibitors block the new formation around the tumor and cut down the supply of oxygen, nutrients and metabolic waste, so that the tumor is hard to proliferate and metastases.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Experimental 1
concurrent chemoradiotherapy（Temozolomide+apatinib） maintenance therapy（Temozolomide）
干预措施: Apatinib (Drug)
Experimental 1
concurrent chemoradiotherapy（Temozolomide+apatinib） maintenance therapy（Temozolomide）
干预措施: Temozolomide（TMZ） (Drug)
control
concurrent chemoradiotherapy（Temozolomide） maintenance therapy（Temozolomide）
干预措施: Temozolomide（TMZ） (Drug)
Experimental 2
concurrent chemoradiotherapy（Temozolomide+apatinib） maintenance therapy（Temozolomide+apatinib）
干预措施: Apatinib (Drug)
Experimental 2
concurrent chemoradiotherapy（Temozolomide+apatinib） maintenance therapy（Temozolomide+apatinib）
干预措施: Temozolomide（TMZ） (Drug)
结局指标
主要结局
Progression-Free-Survival(PFS)
时间窗: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months.
in this Survival Duration neither Progression nor death occurs in the subjects.
Assessment of brain edema
时间窗: From date of randomization until the date of end of the trial, assessed up to 36 months
The average score of edema grading in patients before and after treatment was calculated separately.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
时间窗: From date of randomization until the date of end of the trial, assessed up to 36 months
To observe any adverse events that occurred during the clinical study.
次要结局
未报告次要终点