Phase 3 Study of Carmustine Sustained Release Implant (CASANT) to Treat Newly Diagnosed Malignant Glioma
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 236
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
The purpose of the study is to determine the safety and efficacy of intracranially implanted Carmustine in the treatment of patients with primary malignant glioma.
详细描述
Malignant gliomas recur mostly 2 cm within originated area. Local therapies therefore become particular important. Gliadel wafer developed in the States and marketed in the developed countries is an example of such treatments. The product in this study, Carmustine Sustained Release Implant (CASANT), is similar to that of Gliadel wafer as for the API(Active Pharmaceutical Ingredient), but different as for drug delivering system. As required, the preliminary clinical studies were conducted in China. Based on the results of phase I/II , 8-10 wafers containing given dose of BCNU will be administered intracranially in this phase III to the tumor resected cavity to investigate the safety and efficacy in the treatment of primary malignant glioma in 236 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
- •Confirmation of high grade glioma(WHO III or above)by frozen or squash preparation;
- •Patients must be 18 to 70 years old, signed ICF;
- •At least 4 weeks after previous chemotherapy (6 weeks since nitrosoureas);
- •KPS ≥ 60;
- •Unilateral, Supratentorial, solitary lesion and not crossing the midline
- •No obvious important organ dysfunction: Hepatic function:Serum total bilirubin ≤1.5 times upper limit of laboratory normal; Aspartate aminotransferase (AST) and/or Alanine aminotransferase (ALT)<2.5 times upper limit of laboratory normal; Renal function:Serum creatinine ≤1.5 times upper limit of laboratory normal;
- •Not Pregnant or lactating for women of childbearing potential.
排除标准
- •Underwent cytoreductive surgery(excluded stereotactic biopsy);
- •With chemotherapy or brain radiotherapy history;
- •Tumor located at ventricular system, Open ventricle tumor cavity postoperatively;
- •Concomitant with other life-threatening diseases and with life expectancy <12 months;
- •Allergic to nitrosourea drugs;
- •With history of intracranial radiotherapy or implant chemotherapy;
- •With serious cardiac, pulmonary, hepatic and renal dysfunction, poor glycemic control;
- •Experienced > 3 times of Large epilepsy within one month preoperatively.
- •Investigators thought unsuitable for enrollment.
研究组 & 干预措施
Carmustine Sustained Release Implant
For subjects in this group, they will accept intracranially implanted carmustine intraoperatively.
干预措施: Carmustine (Drug)
Tumor Resection Surgery
For subjects in this control group, they accept no implants while gliomas maximally be resected.
干预措施: tumor resection surgery (Procedure)
结局指标
主要结局
Overall Survival
时间窗: 15 months
次要结局
- Progress Free Survival(15 months)
- Overall Survival Rate at 12 months(15 months)
- Karnofsky Performance Status(KPS)(15 months)
- Quality of Life(QOL)(15 months)
- Safety of intracranially implanted carmustine after maximal tumor resection(15 months)