A multicenter randomized phase III study for recurrent glioblastoma comparing bevacizumab alone with dose-dense temozolomide followed by bevacizumab (JCOG1308C, RE-GEND-pIII)
- Conditions
- Glioblastoma at the first relapse or progression
- Registration Number
- JPRN-UMIN000023108
- Lead Sponsor
- Japan Clinical Oncology Group (JCOG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 210
Not provided
1) Synchronous or metachronous (within 5 years) malignancy, except for carcinoma in situ or mucosal tumors curatively treated with local therapy 2) Active infection requiring systemic therapy 3) Body temperature >= 38 degrees Celsius at registration 4) Women during pregnancy, possible pregnancy, within 28 days after delivery, or breast-feeding 5) Psychosis or with psychotic symptom 6) Continuous systemic use of immunosuppressant except for steroid 7) Uncontrolled diabetes mellitus or routine administration of insulin 8) Unstable angina within 3 weeks, with a history of myocardial infarction within 6 months, or New York Heart Association (NYHA) class II or greater congestive heart failure 9) Inadequately controlled hypertension (cannot be controlled to a systolic pressure of >= 150 mmHg and a diastolic pressure of >= 100 mmHg) 10) History of symptomatic cerebrovascular disorder (including subarachnoid hemorrhage, cerebral infarction and transient ischemic attack) within 6 months or history of vascular disorder requiring intervention (including venous/arterial thrombosis or embolism and aortic aneurysm) within 6 moths 11) History of grade >= 2 hemoptysis within 28 days 12) History of hemorrhagic tendency (e.g., coagulation disorder) or any grade >= 3 hemorrhage within 28 days 13) History of gastrointestinal perforation, fistula, abdominal abscess or uncontrolled peptic ulcer within 6 months 14) Interstitial pneumonia, pulmonary fibrosis, or severe lung emphysema 15) Severe non-healing wound or traumatic fracture at enrolment 16) Hypersensitivity to CHO-derived drugs or other recombinant antibodies 17) Gadolinium allergy 18) Positive HIV antibody 19) Positive HBs antigen
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method