A Phase III Trial on Adjuvant Standard Temozolomide Chemotherapy With or Without Interferon-alpha in Newly Diagnosed High-grade Gliomas
This study is being conducted to help determine whether the addition of
Interferon-alpha(α-IFN),which were determined sensitized the activity of Temozolomide(TMZ)
in vivo and vitro, when given along with temozolomide during the monthly cycles that follow
radiation, is able to delay tumor growth, shrink tumors, or impact how long people with
newly diagnosed high-grade glioma. Four weeks after radiotherapy, newly diagnosed WHO III-IV
glioma patients will be randomised into two groups: TMZ group or TMZ+ α-IFN groups.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Over-all survival
5-year
No
China: Food and Drug Administration
CSNO2012001
NCT01765088
September 2012
September 2015
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