Determination of efficiency of nimotuzumab in adults with glioblastoma multiforma
The objective of the present study is a comparison of treatment of patients with newly diagnosed glioblastoma multiforme grade IV. Patients will be randomized in one of two arms when included. Patients randomly assigned to arm A will receive Nimotuzumab (OSAG 101) plus Temozolomide concomitant with standard radiotherapy. Patients randomised in arm B will receive standard radiotherapy plus Temozolomide treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
monoclonal antibody
Dep. Neurosurgery, Univ. Hamburg
Hamburg, Germany
Progression-free interval determined by MRI
Time frame: week 12, 24, 36, 52
Overall survival Time to reintervention Response rate according to RECIST criteria Toxicity according to CTC criteria Symptom control Quality of life
Time frame: week 12, 24, 36, 52
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