glioblastoma
Conditions
Interventions
Test group:Stereotactic radiotherapy combined with temozolomide chemotherapy
Sponsors
The First Hospital of China Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Subjects aged between 18 and 70 years old. 2.It has been resected through a surgical operation and confirmed by enhanced magnetic resonance imaging (MRI) within 72 hours after the operation. 3.Glioblastoma (WHO grade 4) diagnosed by histopathology and/or molecular biology. 4.The tumor must be in the supratentorial location. 5.The planned target volume (tumor plus the resection margin) must be = 1,500/mm^3(1.5 × 10^9/L) (without the use of growth factors within 14 days); Platelet count >= 100,000/mm^3 (100 × 10^9/L) (without the use of corrective treatment within 7 days); Hemoglobin >=9.0 g/dL (90 g/L) (without the use of corrective treatment within 7 days); Blood biochemistry: Serum creatinine = 60 ml/min; Total bilirubin <= 1.5 × ULN; Aspartate aminotransferase and Alanine aminotransferase <= 2.5 × ULN. 9.The patient voluntarily participates in the study and signs the informed consent form, is expected to have good compliance, and can cooperate with the study as required by the protocol. 10.Women of childbearing age must have a negative pregnancy test result (serum or urine) within 7 days before enrollment, and they must voluntarily use appropriate contraceptive methods during the observation period and within 4 months after the last administration of the study drug.
Exclusion criteria
Exclusion criteria: 1.Multifocal disease or leptomeningeal dissemination. 2.Patients who have previously received radiotherapy to the brain in an area that would result in overlap with the target area. 3.Planned participation in another study involving investigational drugs or devices, or the use of therapeutic devices for treating gliomas. 4.Primary brainstem tumors. 5.A history of malignant tumors within the last 5 years (except basal cell carcinoma or carcinoma in situ of the cervix). 6.Severe chronic or active infections that require systemic antibacterial, antifungal, or antiviral treatment, including tuberculosis infection, etc. 7.Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome, active hepatitis B (HBV DNA >= 1000 IU/ml), hepatitis C (positive for anti-HCV antibody and HCV-RNA higher than the lower limit of detection of the analytical method), or co-infection with hepatitis B and hepatitis C. 8.Patients with untreated chronic hepatitis B, chronic hepatitis B virus (HBV) carriers with HBV DNA > 1000 IU/mL, or patients with active hepatitis C virus (HCV) should be excluded. Note: Inactive hepatitis B surface antigen (HBsAg) carriers, patients with treated and stable hepatitis B (HBV DNA < 1000 IU/mL), and patients with cured hepatitis C are eligible for inclusion. 9.A history of severe hypersensitivity to temozolomide and/or any of its components. 10.Exclude patients with factors that significantly affect the absorption of oral medications (such as inability to swallow, chronic diarrhea, and intestinal obstruction, etc.). 11.Other situations that, in the judgment of the investigator, may affect the conduct of the clinical study and the determination of the study results. 12.Refusal or inability to sign the informed consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival,PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival,OS;Local control rate;Quality of life;Safety;Impact of tumour-related markers on prognosis; | — |
Countries
China
Contacts
Public ContactZheng He
The First Hospital of China Medical University
Outcome results
None listed