39
Participants
Start Date
August 18, 2010
Primary Completion Date
March 23, 2017
Study Completion Date
March 23, 2017
Nimotuzumab
Nimotuzumab, 200 mg as 1-hour intravenous infusion once weekly, from first week to last week of RT for a total of 6 times.
Temozolomide
Temozolomide, 75 mg/m2/d was administered orally from the first to the last day of RT. After 4-week break, individualized adjuvant TMZ was given based on MGMT status. The standard 5-day schedule every 4 weeks for six cycles was given for patients with negative MGMT expression. Dose was 150mg/m2 for the first cycle and 200 mg/m2 from the second cycle. The 7-day on/7-day off schedule every 2 weeks for 12 cycles was given for patients with positive MGMT expression. The dose was 100 mg/m2 for the first two cycles and 150 mg/m2 starting from the third cycle.
Radiotherapy
Fractionated 3D conformal RT was given at 2.0Gy per fraction, 5 daily fractions per week for 6 weeks.
Sun Yat-sen University Cancer Center, Guangzhou
Guangdong Brain Hospital, Guangdong
The First Affiliated Hospital/School of Clinical Medicine of Guangdong, Guangdong
The First Affiliated Hospital of Guangzhou Medical University, Guangzhou
Shenzhen People's Hospital, Shenzhen
Lead Sponsor
Sun Yat-sen University
OTHER
Biotech Pharmaceutical Co., Ltd.
OTHER