malignant glioma
Conditions
Interventions
Tumor is removed 21~30 days after one course of neoadjuvant bevacizumab and temozolomide chemotherapy. Radiation and temozolomide combination therapy is initiated more than 10 days after the operation
Sponsors
Keio university school of medicine
Jikei University Kashiwa Hospital Kagawa University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Newly diagnosed supratentorial malignant glioma primarily by imaging findings (ring enhancement and marked peritumoral edema on MRI) that is expected to gain a benefit from the neoadjuvant strategy (ex.hypervascular tumor, tumors with invasion into eloquent area). 2) Age between 18 to 75 3) Performance status (ECOG) of 0-2 4) Sufficient function of important organs. Neu>1,500/mm3, Hb>8.0 g/dL, Plt>100,000/mm3, AST and ALT<3 times normal value, Bil<2.0 mg/dL, Cr<1.5 mg/dL, ECG: normal, lung function:SpO2>92% 5) Written informed consents are obtained.
Exclusion criteria
Exclusion criteria: 1) Uncontrollable severe infectious diseases. 2) Presence of active other cancers. 3) History of radiotherapy for head 4) Uncontrollable hypertention: SAP>150mmHg, DBP>100mmHg 5) Clinically significant cardiac disease (ex. congestive heart failure:NYHA gradeII) 6) Symptomatic myocardial infarction, cerebral infarction, deep vein thrombosis and pulmonary embolism within 6 months 7) Symptomatic intracerebral hemorrhage within 6 months 8) Hemoptysis within 28 days (CTCAE v4.0: grade2) 9) Bleeding diathesis and blood coagulation disorder 10) Unhealed scar and untreated bone fracture 11) Severe gastric ulcer 12) Pulmonary fibrosis and interstitial pneumonia 13) Pregnancy or lactation. Patients hope pregnancy 14) Allergy for temozolomide or bevacizumab 15) Allergy for gadolinium 16) Judged as inappropriate for this study by doctors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| safety (adverse event related to neoadjuvant chemotherapy, the rate of accomplishment of the planned operation following neoadjuvant chemotherapy) response rate for neoadjuvant bevacizumab and temozolomide chemotherapy (Response assessment in neuro-oncology (RANO) and tumor volume decrease according to sum of products of diameters (SPD)) two year survival rate overall survival | — |
Countries
Japan
Contacts
Public ContactHikaru Sasaki
Keio university school of medicine Department of Neurosurgery
Outcome results
None listed