Clinical Trial: A Phase III Trial on Adjuvant Temozolomide With or Without Interferon-alpha in Newly Diagnosed High-grade Gliomas

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase III Trial on Adjuvant Standard Temozolomide Chemotherapy With or Without Interferon-alpha in Newly Diagnosed High-grade Gliomas

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: Sun Yat-sen University

Current Primary Outcome: Over-all survival [ Time Frame: 5-year ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Quality of life [ Time Frame: 5-year ]

Original Secondary Outcome: Same as current

Information By: Sun Yat-sen University

Dates:
Date Received: January 7, 2013
Date Started: September 2012
Date Completion: December 2017
Last Updated: December 10, 2015
Last Verified: December 2015