recurrent glioblastoma
Conditions
Interventions
study group:Metronomic Temozolomide + Bevacizumab
Sponsors
The First Affiliated Hospital of Xiamen University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Pathologically confirmed glioblastoma multiforme (WHO Grade IV) with postoperative recurrence, and = 3 months since the initial diagnosis. 2. Aged >= 18 years and = 6 months since the completion of the first course of radiotherapy, and deemed to tolerate stereotactic body radiation therapy (SBRT) after a comprehensive evaluation. 4. = 60, eligible to tolerate chemotherapy and radiotherapy. 6. Hematological parameters: Absolute Neutrophil Count (ANC) >= 1.5 × 10?/L, platelet count >= 100 × 10?/L, hemoglobin >= 90 g/L; creatinine clearance rate >= 80 mL/min; total bilirubin <= 1.5 × ULN, aspartate aminotransferase (AST)/alanine aminotransferase (ALT) <= 2.5 × ULN; alkaline phosphatase <= 5 × ULN. 7. No severe dysfunction of vital organs including the heart and lungs. 8. No history of other malignant tumors. 9. Voluntarily sign a written informed consent form and agree to cooperate with study follow-up.
Exclusion criteria
Exclusion criteria: 1. Refusal to sign the informed consent form; 2. Patients unable to cooperate with regular follow-up due to psychological, social, family or geographical reasons; patients concurrently receiving experimental treatment in other clinical studies (during the treatment phase of clinical research). 3. Severe and uncontrollable infection or internal medical diseases. 4. Dysfunction of vital organs, decompensated heart, lung, kidney or liver failure (e.g., severe cardiac insufficiency with NYHA class >= III or left ventricular ejection fraction (LVEF) = 4 lesions or diffuse enhancement on imaging). 7. Recurrent lesions complicated with significant peritumoral edema (edema volume/tumor volume > 3:1) or symptoms of increased intracranial pressure that are uncontrollable with corticosteroids. 8. Uncontrolled hypertension (systolic blood pressure >= 160 mmHg or diastolic blood pressure >= 100 mmHg). 9. Active bleeding tendency (e.g., a history of recent gastrointestinal bleeding 1.5 or activated partial thromboplastin time (APTT) > 1.5 × upper limit of normal (ULN)). 10. Pregnant or lactating women; women of childbearing potential who fail to take effective contraceptive measures (a negative pregnancy test is required for women of childbearing potential before enrollment).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Median progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse Event;1-year overall survival rate;quality of life;Six-month progression-free survival rate; | — |
Countries
China
Contacts
Public ContactWu Sangang
The First Affiliated Hospital of Xiamen University
Outcome results
None listed