newly diagnosed glioblastoma
Conditions
Interventions
Experimental:sertraline, radiotherapy, temozolomide
Control group:radiotherapy, temozolomide
Sponsors
Tangdu Hospital,Fourth Military Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The participants of this study voluntarily enrolled, provided informed consent, and demonstrated good compliance. 2. Inclusion criteria for this study were as follows: age between 18 and 75 years at the time of informed consent, Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2 (Karnofsky Performance Status score = 60), expected survival period exceeding 3 months. 3. The diagnosis of glioblastoma was confirmed histologically according to the World Health Organization (WHO) Classification of Central Nervous System Tumors. 4. Participants were randomly assigned to the study intervention 4-6 weeks after their most recent surgery (including biopsy, surgical resection, or other procedures involving the skull), and were deemed by the researcher to have adequately healed surgical wounds. 5. The dosage of Corticosteroid was maintained at a stable level or gradually decreased within a period of 5 days prior to administration. 6. The primary organs exhibit satisfactory performance and conform to the following criteria: a) The blood routine test must satisfy the following examination standards (without any blood transfusion or correction with hematopoietic stimulating factor drugs within the initial 7 days of randomization): hemoglobin (HGB) level = 90 g/L; Neutrophil absolute value (NEUT)=1.5× 109/L; Platelet count (PLT)=90×109/L. b. In order to adhere to appropriate biochemical and coagulation function standards, it is recommended that total bilirubin (TBIL) not exceed 1.5 times the upper limit of normal value (ULN), and that Alanine aminotransferase (ALT) and Aspartate amino transferase (AST) remain below 2.5 × ULN. In cases where liver metastasis is present, ALT and AST should not exceed 5 × ULN. Additionally, serum creatinine (Cr) should not exceed 1.5 × ULN or creatinine clearance rate (Ccr) should be at least 60ml/min. C. Coagulation function tests should also meet the following standards: Prothrombin time (PT), activated partial thromboplastin time (APTT), and international standardized ratio (INR) should not exceed 1.5 × ULN, unless the patient is receiving anticoagulant therapy. d.The assessment of left ventricular ejection fraction (LVEF) through color Doppler echocardiography should yield a result of no less than 50%. 7.Female participants of reproductive age must consent to the use of contraceptive measures, such as intrauterine devices, contraceptives, or condoms, throughout the duration of the study and for a period of 6 months following its conclusion. Prior to inclusion in the study, female subjects must have tested negative for pregnancy within 7 days and must not be lactating. Male participants must also agree to use contraception during the study period and for 6 months after its completion.
Exclusion criteria
Exclusion criteria: 1. The patient has a history of systemic radiotherapy and chemotherapy for GBM. 2. The presence of an IDH1/2 mutation has been identified. 3. Individuals who are unable to undergo MRI examination are included in the study. 4. The tumors are exclusively localized in the brainstem. 5. Imaging reveals diffuse meningeal dissemination. 6. The imaging results (CT/MRI) indicate that the tumor has infiltrated critical blood vessels or is highly likely to do so, leading to fatal massive bleeding, cerebral vascular malformations, or other bleeding tendencies during subsequent investigations, as determined by the researcher. 7.Within a period of six months, occurrences of arterial/venous thrombosis/cancer thrombus events were observed, including cerebrovascular accidents such as temporary ischemic attack, cerebral hemorrhage, and cerebral infarction, as well as deep vein thrombosis and pulmonary embolism. 8.Additionally, individuals who have experienced or are currently suffering from other malignant tumors within the past three years may be included in this group, with the exception of those who have undergone a single surgery and achieved disease-free survival for five consecutive years, or those who have been cured of cervical carcinoma in situ, non-melanoma skin cancer, or superficial bladder tumor[Ta (non invasive tumor), Tis (Carcinoma in situ) and T1 (tumor infiltrating basement membrane)]. 9.Numerous factors, including but not limited to dysphagia, chronic diarrhea, and bowel obstruction, have been identified as influencing oral medicine. 10.Additionally, individuals with severe and/or uncontrolled medical conditions, such as a) poor blood pressure regulation (systolic blood pressure=150mmHg or diastolic blood pressure=100 mmHg); b) myocardial ischemia or infarction of level 2 or higher, arrhythmia (including QTc=50ms (male), QTc=470ms (female)), and congestive heart failure of level 2 or higher (as classified by the New York Heart Association); c) Severe infections that are active or uncontrollable, with a Common Terminology Criteria for Adverse Events (CTC AE) level of 2 or higher; d) The presence of pneumonia with a CTC AE level of 2 or higher; e) A clinically significant history of liver disease, including viral hepatitis. Individuals who are carriers of hepatitis B virus (HBV) must confirm the absence of active HBV infection, as indicated by HBV DNA positivity exceeding 2500 copies/mL or 500 IU/mL, and exceeding the upper limit of normal values. Additionally, individuals with known hepatitis C virus (HCV) infection and HCV RNA positivity exceeding 1 × 103 copies/mL, or other decompensated liver diseases, are included in this category. f) Individuals with a prior medical history of immunodeficiency, such as those who are HIV positive or have acquired or congenital immunodeficiency diseases, or those who have undergone organ transplantation; g) Inadequate management of diabetes, as indicated by a fasting blood sugar (FBG) level exceeding 10mmol/L; h) Urinary routine examination revealing a urine protein level of =++, and confirmed by a 24-hour urine protein quantification exceeding 1.0g; i) Presence of clinically significant thyroid dysfunction, unresponsive to drug treatment and/or lacking clinical significance. 11. Two weeks prior to randomization, the participant received traditional Chinese patent medicines and simple preparations, such as compound cantharides capsule, Kangai injection, Kanglaite capsule/injection, Aidi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Objective Response Rate;Karnofsky Performance Status;Quality of life score;Cognitive function; | — |
Countries
China
Contacts
Public ContactLiang Wang
Tangdu Hospital,Fourth Military Medical University
Outcome results
None listed