This study aimed to investigate the clinical benefit contribution and safety of nimotuzumab to the standard combined treatment for patients with newly diagnosed glioblastoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
39
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, 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.
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, China
Guangdong Brain Hospital
Guangdong, China
The First Affiliated Hospital/School of Clinical Medicine of Guangdong
Guangdong, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, China
Progression-free survival (PFS)
PFS will be calculated as the time from surgery to the date of progression-free.
Time frame: 2 years
Overall survival (OS)
OS will be calculated as the time from surgery to the date of death.
Time frame: 2 years
Objective Response Rate (ORR)
ORR: overall response rate (ORR), subjects will be classified according to the RANO criteria, which is a composite of MRI changes, clinical response and changes in steroid use.
Time frame: 6 months
Incidence of adverse events
Incidence of adverse events.Toxicities will be tabulated and graded according to the NCI Common Toxicity Criteria (CTCAE) version 3.
Time frame: 6 months
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Shenzhen People's Hospital
Shenzhen, China