Monosialoganglioside Ganglioside in Cerebral Radiation Necrosis
试验速览
- 阶段
- 2 期
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Objective response rate
研究概览
简要总结
Monosialoganglioside Ganglioside in Cerebral Radiation Necrosis
详细描述
A prospective phase II trial was conducted to test the efficacy of monosialoganglioside ganglioside for the treatment of cerebral radiation necrosis
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
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
- •Undergone only one course of definitive radiotherapy for histologically confirmed nasopharyngeal carcinoma years before;
- •At least two consecutive MRI study supporting the diagnosis of cerebral radiation necrosis(CRN) with an interval of 3-4 months, with the second MRI showing progressive disease compared with the first MRI;
- •Progressive neurologic symptoms or signs;
- •Mini-mental status examination(MMSE) score must be ≤27;
- •Karnofsky performance status≥70 ;
- •Supposed to live more than 6 months.
排除标准
- •After the second course of radiotherapy for recurrent nasopharyngeal carcinoma;
- •Local or regional relapse,or with distant metastasis;
- •Cerebrovascular disease;
- •Second primary malignancy;
- •Diabetes.
研究组 & 干预措施
Pulsed steroid
Pulse steroid, methylprednisolone, was administered by intravenous infusion over 3 consecutive days. Three grams of methylprednisolone was given in each cycle. Administration of 1 g was infused over 1 h daily for 3 days on an in-patient basis, which then tailed off in 10 days with administration of oral prednisolone.
干预措施: Methylprednisolone (Steroid Hormone) (Drug)
Pulsed steroid
Pulse steroid, methylprednisolone, was administered by intravenous infusion over 3 consecutive days. Three grams of methylprednisolone was given in each cycle. Administration of 1 g was infused over 1 h daily for 3 days on an in-patient basis, which then tailed off in 10 days with administration of oral prednisolone.
干预措施: Prednisolone (Drug)
Monosialoganglioside ganglioside
Monosialoganglioside ganglioside was given at 100 mg/time, once a day for 2 months.
干预措施: Monosialoganglioside Ganglioside (Drug)
结局指标
主要结局
Objective response rate
时间窗: From the first day of treatment, to 3 months after treatment
Response Evaluation Criteria in Solid Tumors (RECIST) were used.
次要结局
未报告次要终点