Glioblastoma
Conditions
Interventions
Standard Treatment Group:Concurrent chemoradiotherapy with temozolomide at a dose of 75 mg/m^2/day for 42 consecutive days. Four weeks after the completion of concurrent chemoradiotherapy, adjuvant ch
Combined Treatment Group:During the concurrent chemoradiotherapy period, etoposide will be added to the regimen of the Standard Treatment Group at a dose of 50 mg/day for 2 consecutive weeks, repeated
Sponsors
Cancer Research Institute of the Chinese People’s Liberation Army, Xinqiao Hospital, Army Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Subjects whose postoperative pathology is confirmed as glioblastoma (WHO Grade 4) and whose MGMT promoter is confirmed as unmethylated by genetic testing; 2. Expected survival time >= 3.0 months; 3. Karnofsky Performance Status (KPS) score >= 70 points; 4. Within 1 week prior to randomization, the subject’s bone marrow function and hepatic and renal function meet the following criteria: hemoglobin >= 100 g/L, neutrophils >= 1.5×10^9/L, platelets >= 100×10^9/L; total bilirubin = 60 mL/min, blood urea nitrogen <= 200 mg/L; 5. Women of childbearing potential must have a negative urine pregnancy test performed within 7 days before initiation and must not be breastfeeding. Male and female subjects of childbearing potential agree to use a reliable method of contraception prior to study entry, during the study, and for 6 months after the completion of all treatment; 6. Written informed consent has been obtained from the subject and/or their legal representative; 7. The subject is compliant with the study protocol and follow-up procedures, and is able to receive oral medication; 8. Age: 18–70 years old.
Exclusion criteria
Exclusion criteria: 1. Subjects with recurrence after previous conventional radiotherapy; 2. Subjects enrolled in other clinical studies; 3. Subjects complicated with other malignancies that are expected to affect their survival; 4. Any unstable systemic disease, including active infection, uncontrolled hypertension, congestive heart failure, myocardial infarction, severe arrhythmia requiring pharmacologic treatment, hepatic, renal or metabolic disease, neuropathy/psychiatric disorder such as Alzheimer’s disease; 5. Known human immunodeficiency virus (HIV) infection; 6.Any concomitant disease that, in the investigator’s judgment, may seriously compromise the subject’s safety, interfere with the subject’s ability to complete the study, or affect subject compliance with the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free-Survival, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, OS; | — |
Countries
China
Contacts
Public ContactGuanghui Li
Cancer Research Institute of the Chinese People’s Liberation Army, Xinqiao Hospital, Army Medical University
Outcome results
None listed