Newly diagnosed glioblastoma
Conditions
Interventions
Implantation of BCNU wafers (maximum 8 wafers) Radiation therapy (local site, 60Gy, 30 fractions) Temozolomide (concomitant phase: 75mg/m2, maintenance phase: 150-200mg/m2, 6 dose) Bevacizumab (10m
Sponsors
Tohoku University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Temporal registration 1) No prior treatment for glioma. 2) Preoperative MRI suggests that the lesion is glioblastoma, and total resection of the enhanced lesion is possible. 3) No systemic metastatic lesions. 4) More than or equal to 50% of tumor must be located in cerebrum or diencephalon. 5) No multicentric lesions, dissemination, nor invasion to optic, olfactory nerve, or pituitary gland. 6) Age must be >= 20 and <= 75 years old. 7) Written informed consent must be provided. Definitive registration 1) Histologically verified glioblastoma based on WHO classification. 2) Planning target volume must be less than one- third of volume of cerebrum and diencephalon. 3) There must be no measurable lesion on MR images obtained within 72 hours after resection. 4) Patients must be registered >= 3 days and <= 20 days after resection. 5) ECOG PS must be 0-2, and 3 due to neurological symptoms caused by tumor. 6) Adequate bone marrow, hepatic, renal, coagulation function.
Exclusion criteria
Exclusion criteria: 1) Evidence of recent and progressive or symptomatic intracranial hemorrhage on the postoperative MRI. 2) Prior chemotherapy, radiotherapy, or immunotherapy for cancer of other organ. 3) Prior radiotherapy to the brain for the lesion other than glioma. 4) Uncontrolled hypertension (systolic pressure >= 150, diastolic pressure >= 100). 5) History of hypertensive crisis, 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) Pregnant or women of childbearing potential and men who are sexually active and not willing to use medically acceptable forms of contraception. Lactating women are not permissible. 14) Allergy to temozolomide, carmustine, bevacizumab 15) Contraindication of gadolinium contrast agent due to allergy or other reasons. 16) Patients registering other clinical trial. 17) Any other medical or psychiatric impairments that will prevent administration of protocol therapy in the investigator opinion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year overall survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival time Progression-free survival time Local recurrence-free survival time KPS deterioration free survival time Adverse events Severe adverse events | — |
Countries
Japan
Contacts
Public ContactMasayuki Kanamori
Tohoku University Graduate School of Medicine Department of Neurosurgery
Outcome results
None listed