Newly diagnosed glioblastoma
Conditions
Interventions
Temozolomide plus bevacizumab with radiotherapy. Subsequent treatment of continuous bevacizumab as 2nd line treatment
Sponsors
EPS Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Supratentorial, newly diagnosed and histologically confirmed glioblastoma (GBM, WHO GradeIV). (2)Registration should be completed >=7days and <21days after craniotomy or biopsy, without drainage and infection. Surgical specimens should be available for genetic analyses. (3)Patients without dissemination nor gliomatosis cerebri. (4)Have provided written informed consent to enroll and supply the specimens prior to any trial specific procedures. (5)Age >=20 years, <=75 years. (6)Karnofsky performance status >=60. (7)Regardless of the presence of mesurable lesions. (8)Estimated life expectancy at least 3 months. (9)Adequate organ function indicated by all of the following. When there are more than one test results, the latest should be adopted. 1).neutrophil count >=1,500/mm3 2).Platelet count >=10.0*the fourth power of10/mm3 3).Haemoglobin >=9.0g/dL 4).Total bilirubin <=1.5mg/dL 5).AST, ALT <=120IU/L 6).Serum creatinine <=1.5mg/dL 7).Proteinuria <=1+ 8).PT-INR <=1.5 NOTE:When treated with warfarin; 1.5<=, <=2.5
Exclusion criteria
Exclusion criteria: (1)Evidence of recent haemorrhage on postoperative magnetic resonance imaging of the brain. (2)Any prior chemotherapy, radiotherapy or immunotherapy (including vaccine therapy) for GBM. (3)Inadequately controlled hypertension. (4)Prior history of hypertensive crisis, or hypertensive encephalopathy. (5)New York Heart Association Grade II or greater congestive heart failure. (6)Other malignancy within 5 years prior to trial enrolment. (7)Active infection requiring systemic treatment. (8)Diabetic with continued insulin treatment or uncontrolled. (9)Have received continued administration of steroids to some systemic disease. (10)Any of the following medical history within 6 months prior to registration. 1)myocardial infarction or unstable angina 2)stroke or TIAs 3)Significant vascular disease 4)Abdominal fistula or perforation of the digestive tract 5)Intracranial abscess (11)History of >= grade 2 hemoptysis within 28 days prior to registration. (12)Evidence of bleeding diathesis or coagulopathy. (13)Serious non-healing wound, active ulcer or untreated bone fracture. (14)Pregnancy or lactation, as well as fertile women and men unwilling or unable to use effective means of contraception. (15)Known hypersensitivity to any of the trial drugs. (16)Patients with allergy to gadolinium. (17)Patients with active hepatic disease. (18)Attending physician has determined unsuitable to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-years survival rate of patients who can be treated with continuous bevacizumab from the 1st line treatment to the 2nd line treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1). 2-years survival rate of all patients. 2). Overall survival of patients who can treated with continuous bevacizumab from the 1st line treatment to the 2nd line treatment. 3). Overall survival of all patients. 4). Progression free survival(the 1st line treatment). 5). KPS maintenance term(the 1st line treatment). 6). Response rate(the 1st line treatment). 7). QoL (Quality of Life):EORTC QLQ-C30,EORTC BN20,MDASI-BT 8). NCF (Neurocognitive Function):MMSE,HVLT-R,TMT,COWA 9). Safety | — |
Countries
Japan
Contacts
Public ContactRyo Nishikawa
Saitama International Medical Center, Saitama Medical University Department of Neuro-Oncology/Neurosurgery
Outcome results
None listed