Safety and Efficacy Study of Intracranially Implanted Carmustine to Treat Newly Diagnosed Malignant Glioma
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|ClinicalTrials.gov Identifier: NCT01656980|
Recruitment Status : Unknown
Verified August 2012 by Shandong Lanjin Pharmaceuticals Co.,Ltd.
Recruitment status was: Not yet recruiting
First Posted : August 3, 2012
Last Update Posted : August 3, 2012
|Condition or disease||Intervention/treatment||Phase|
|Anaplastic Astrocytoma Anaplastic Oligodendroglioma Anaplastic Oligoastrocytoma Glioblastoma||Drug: Carmustine Procedure: tumor resection surgery||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||236 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 3 Study of Carmustine Sustained Release Implant (CASANT) to Treat Newly Diagnosed Malignant Glioma|
|Study Start Date :||August 2012|
|Estimated Primary Completion Date :||August 2014|
|Estimated Study Completion Date :||December 2014|
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
- Overall Survival [ Time Frame: 15 months ]
- Progress Free Survival [ Time Frame: 15 months ]
- Overall Survival Rate at 12 months [ Time Frame: 15 months ]
- Karnofsky Performance Status(KPS) [ Time Frame: 15 months ]
- Quality of Life(QOL) [ Time Frame: 15 months ]
- Safety of intracranially implanted carmustine after maximal tumor resection [ Time Frame: 15 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01656980
|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|