An exploratory phase II study of neoadjuvant bevacizumab and temozolomide chemotherapy for patients with newly diagnosed malignant glioma
- Conditions
- malignant glioma
- Registration Number
- JPRN-UMIN000025579
- Lead Sponsor
- Keio university school of medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 15
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression free survival
- Secondary Outcome Measures
Name Time Method 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