Safety and Efficacy Study of Intracranially Implanted Carmustine to Treat Newly Diagnosed Malignant Glioma
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.
Procedure: tumor resection surgery
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase 3 Study of Carmustine Sustained Release Implant (CASANT) to Treat Newly Diagnosed Malignant Glioma|
- Overall Survival [ Time Frame: 15 months ] [ Designated as safety issue: No ]
- Progress Free Survival [ Time Frame: 15 months ] [ Designated as safety issue: No ]
- Overall Survival Rate at 12 months [ Time Frame: 15 months ] [ Designated as safety issue: No ]
- Karnofsky Performance Status(KPS) [ Time Frame: 15 months ] [ Designated as safety issue: No ]
- Quality of Life(QOL) [ Time Frame: 15 months ] [ Designated as safety issue: No ]
- Safety of intracranially implanted carmustine after maximal tumor resection [ Time Frame: 15 months ] [ Designated as safety issue: Yes ]Occurrence rate of adverse event and serious adverse event revealed by laboratory test outcomes including blood routine and chemistry as well as physical examination, vital signs including blood pressure, temperature, respiratory rate , heart rate.
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
Experimental: Carmustine Sustained Release Implant
For subjects in this group, they will accept intracranially implanted carmustine intraoperatively.
As Experimental group, subjects will accept specified wafers of carmustine in the cavity while gliomas maximally be resected.
Sham Comparator: Tumor Resection Surgery
For subjects in this control group, they accept no implants while gliomas maximally be resected.
Procedure: tumor resection surgery
For this group, subjects will accept routine tumor resection surgery and place no implant wafers.
Other Name: blank control group
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.
|Contact: Yan H Sun, M.D.||+firstname.lastname@example.org|
|Contact: Jian J Yu, Masteremail@example.com|
|Beijing Tiantan Hospital Affiliated to Capital Medical University||Not yet recruiting|
|Beijing, Beijing, China, 100050|
|Contact: Yan H Sun, M.D. +86-1360-1389-945 firstname.lastname@example.org|
|Contact: Jian J Yu, Master +86-15336402751 Yujj@lanjin.cn|
|Principal Investigator:||Yan H Sun, M.D.||Beijing Tiantan Hospital affiliated to Capital Medical University|