Status:
COMPLETED
Nimotuzumab Plus Radiotherapy With Concomitant and Adjuvant Temozolomide for Cerebral Glioblastoma
Lead Sponsor:
Biotech Pharmaceutical Co., Ltd.
Collaborating Sponsors:
Sun Yat-sen University
Conditions:
Glioblastoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This study aimed to investigate the clinical benefit contribution and safety of nimotuzumab to the standard combined treatment for patients with newly diagnosed glioblastoma.
Eligibility Criteria
Inclusion
- Newly diagnosed, histologically proven single supratentorial GBM (WHO grade 4);
- EGFR positive;
- \>50％ of the gross tumor volume removed by surgery；
- Karnofsky performance score (KPS) ≥ 60;
- Adequate renal function (creatinine ≤1.5×upper limit of normal \[ULN\] or creatinine clearance ≥ 60 mL/min), hepatic function (total bilirubin ≤1.5×ULN and serum transaminases ≤3×ULN), and hematologic function (white blood cell count ≥ 3,000/uL or absolute neutrophil count ≥ 1,500/uL, platelets ≥ 100,000/uL, and hemoglobin ≥ 10 g/dL).
- Tumor tissue was required for central pathology review and re-checking EGFR and MGMT expression status;
- An interval of 2 to 6 weeks between surgery and RT was required.
Exclusion
- Negative EGFR expression;
- Prior chemotherapy, anti-EGFR therapy, RT, or a history of malignancy in the previous 5 years;
- Patients with severe complications or active infection;
- Continuous vomiting that could interfere with the oral administration of TMZ;
- Pregnancy
Key Trial Info
Start Date :
August 18 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 23 2017
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT03388372
Start Date
August 18 2010
End Date
March 23 2017
Last Update
January 3 2018
Active Locations (5)
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1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
2
Guangdong Brain Hospital
Guangdong, China
3
The First Affiliated Hospital/School of Clinical Medicine of Guangdong
Guangdong, China
4
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, China