glioblastoma
Conditions
Interventions
Radiation therapy (local site, 60Gy, 30 fractions) Temozolomide (concomitant phase: 75mg/m2, maintenance phase: 150-200mg/m2) Bevacizumab (10mg/kg, starting at week 4 of radiotherapy, 12 doses)
Sponsors
Fujita Health University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Histologically verified glioblastoma based on WHO classification. (1) No prior treatment for glioma. (2) initial glioma (3) tumor was resected more than 90 % based on postoperative MRI (4) More than or equal to 50% of tumor must be located in cerebrum or diencephalon. (5) clinically no metastatic tumors (6) No multicentric lesions nor dissemination on preoperative MRI. (7) ECOG PS must be 0-2, and 3 due to neurological symptoms caused by tumor. (8) Age must be >= 20 and <= 75 years old. (9) Written informed consent must be provided. (10)meet the criteria shown below. The latest results should be adopted. 1) neutrophil count >=1,500/mm3 2) Haemoglobin >=8.0g/dL 3) Platelet count >=10.0*the fourth power of10/mm3 4) AST <=120IU/L 5) ALT <=120IU/L 6) Serum creatinine <=1.5mg/dL 7) Proteinuria <=1+ 8) PT-INR <=1.5
Exclusion criteria
Exclusion criteria: (1) Evidence of recent haemorrhage on postoperative MRI. (2) Any prior chemotherapy, radiotherapy or immunotherapy (including vaccine therapy) for glioma. (3) Prior radiotherapy to the brain. (4) Uncontrolled hypertension (systolic pressure >= 150, diastolic pressure >= 100). (5)Prior history of hypertensive crisis, or hypertensive encephalopathy. (6)Congestive heart failure (NYHA class III, or greater) (7)History of hemoptysis (Grade 2 or higher in CTCAE v4.0) within 1 month. (8) Coagulopathy (9) Uncontrolled gastrointestinal ulceration. (10) Serious or non-healing wound or traumatic bone fracture. (11) Past history within 6 months, as follows. Unstable angina, acute myocardial infarction, symptomatic cerebral infarction, arterial or venous thrombosis which required medical treatment, digestive tract perforation or abdominal fistula,intra-abdominal abscess, and intracranial abscess (12) Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ (13) Pregnancy or lactation, as well as fertile women and men unwilling or unable to use effective means of contraception (14) Allergy to temozolomide, bevacizumab (15) Patients with allergy to gadolinium. (16) Patients registering other clinical trial. (17) Attending physician has determined unsuitable to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival, time of high KPS | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival, 2-year survival rate, the rae of adverse events, the rate of severe adverse events | — |
Countries
Japan
Contacts
Public ContactShigeo Ohba
Fujita Health University Department of Neurosurgery
Outcome results
None listed