Nimotuzumab Plus Radiotherapy With Concomitant and Adjuvant Temozolomide for Cerebral Glioblastoma

PHASE2CompletedINTERVENTIONAL
Enrollment

39

Participants

Timeline

Start Date

August 18, 2010

Primary Completion Date

March 23, 2017

Study Completion Date

March 23, 2017

Conditions
Glioblastoma
Interventions
BIOLOGICAL

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.

DRUG

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.

RADIATION

Radiotherapy

Fractionated 3D conformal RT was given at 2.0Gy per fraction, 5 daily fractions per week for 6 weeks.

Trial Locations (5)

510060

Sun Yat-sen University Cancer Center, Guangzhou

Unknown

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

All Listed Sponsors
collaborator

Sun Yat-sen University

OTHER

lead

Biotech Pharmaceutical Co., Ltd.

OTHER