A Prospective Multicenter Randomized Controlled Clinical Trial of Neoadjuvant Temozolomide Combined With Simultaneous Increased Intensity-modulated Radiotherapy in the Treatment of Glioblastoma
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Objective response rate
研究概览
简要总结
This study is a prospective, multi-center, randomized controlled clinical study. Indications: Glioblastoma diagnosed after surgery (WHO grade IV). The patient received conventional postoperative concurrent radiotherapy and chemotherapy, or neoadjuvant temozolomide combined with concurrent increased intensity-modulated radiotherapy. According to data from previous clinical trials, conventional doses of concurrent radiotherapy and chemotherapy PFS 6.9 months neoadjuvant temozolomide combined with concurrently increased intensity-modulated radiotherapy PFS 13.7 months, an estimated 20% leakage rate, and a total sample size of 80 patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Age: 18 to 70 years old
- •A patient with high-grade (WHO grade IV) glioma diagnosed pathologically
- •ECOG score ≤ 3 points
- •The expected survival time is greater than 3 months
- •Patients undergoing surgery for the first time
- •Patients who have not received radiotherapy at the treatment site in the past
- •The following hematological indicators need to be met Neutrophil count ≥1.5×109/L Hemoglobin ≥9g/dL Platelet count ≥70×109/L
- •The following biochemical indicators need to be met Total bilirubin≤1.5×upper limit of normal (ULN) AST and ALT<1.5×ULN Creatinine clearance rate ≥60ml/min
- •Patients of childbearing age need to take appropriate protective measures (contraception or other methods of birth control) before enrollment and during the trial
- •The signed informed consent form
- •Ability to follow research protocols and follow-up procedures
排除标准
- •Patients with recurrent glioma who have previously undergone surgery or radiotherapy and chemotherapy
- •Glioma of the spinal cord
- •ECOG score> 3 points
- •Severe mental symptoms; uncontrollable status epilepticus
- •Patients with malignant tumors in other parts
- •The patient has an active bacterial, viral or fungal infection (≥ Grade 2 NCI-CTC, 4th edition)
- •The patient has severe liver and kidney dysfunction, HIV infection, HCV infection, uncontrollable coronary artery disease or asthma, uncontrollable cerebrovascular disease or other diseases that the researcher thinks cannot be included in the group
- •Pregnant and lactating women. Women of childbearing age must have a negative pregnancy test within 7 days before joining the group
- •Drug abuse, clinical, psychological or social factors affect informed consent or research implementation
- •Any uncertain factors that affect the safety or compliance of patients
结局指标
主要结局
Objective response rate
时间窗: Two years after all treatments are over
RANO criteria: evaluate the therapeutic effect of glioma through MRI and clinical manifestations.
次要结局
未报告次要终点
研究者
Yang Yang
Professor of medicine
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School