Glioma
Conditions
Interventions
Treatment group:None
Control group:None
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Experimental group: (1) Patients with low-grade glioma who are scheduled to undergo postoperative radiotherapy in our center; (2) Patients with postoperative radiotherapy indications, such as low-grade glioma patients who do not achieve total resection or other low-grade gliomas that are clinically considered to require postoperative supplementary radiotherapy; (3) low-grade gliomas that can be diagnosed by histopathology, including oligodendroglioma (WHO grade 2 or 3), IDH-positive astrocytoma (WHO grade 2 only); (4) The overall survival of the patients is expected to be greater than 5 years; (5) Adults with no gender limit, KPS greater than 70 points, and over 18 years old; (6) The patients should be included in the education level of at least primary school or above, who can understand the instructions of magnetoencephalography and cooperate with the completion of magnetoencephalography; (7) Good postoperative function of major organs, laboratory and examination indicators meet the following requirements: 1) Routine blood test: Hemoglobin >=90 g/L (no blood transfusion within 14 days); Neutrophil count >=1.5×10^9/L; Platelet count >=80×10^9/L; 2) Biochemical examination: Total bilirubin = 50 ml/min (Cockcroft-Gault formula); (8) No obvious language function, motor function, or cognitive dysfunction after surgery; (9) Patients and their families have good compliance, and their families agree to cooperate with the examination and follow-up; (10) Patients or family members sign the informed consent form. 2. Control group: (1) Patients with low-grade glioma who have completed postoperative radiotherapy in the usual mode in our center from January 2020 ~ July 2025; (2) low-grade gliomas with clear histopathological diagnosis, including oligodendroglioma (WHO grade 2 or 3), IDH-positive astrocytoma (WHO grade 2 only); (3) The overall survival of patients is expected to be greater than 5 years; (4) Adults with KPS greater than 70 points before radiotherapy and over 18 years old; (5) Good postoperative function of major organs, laboratory and examination indicators meet the following requirements: 1) Routine blood test: Hemoglobin >=90 g/L (no blood transfusion within 14 days); Neutrophil count >=1.5×10^9/L; Platelet count >=80×10^9/L; 2) Biochemical examination: Total bilirubin = 50 ml/min (Cockcroft-Gault formula); (6) No obvious language function, motor function, or cognitive dysfunction after surgery; (7) Patients and their families have good compliance, relatively complete follow-up records, and at least information on recurrence progression or current disease status can be obtained.
Exclusion criteria
Exclusion criteria: 1. Treatment group (1) The histopathological diagnosis could not be obtained, and the indications for postoperative radiotherapy were unclear; (2) WHO grade 3-4 gliomas except WHO grade 3 oligodendroglioma; (3) The primary lesion was located in the thalamus or brain stem, or the maximum diameter of the postoperative residual lesion was greater than 3cm; (4) Spinal cord MR or cerebrospinal fluid examination showed evidence of spinal cord dissemination; (5) patients with other malignant tumors at the same time, except those with cured or stable malignant tumors; (6) previous history of brain radiotherapy; (7) patients under 18 years old; (8) pregnant or lactating women; (9) participated in other clinical trials within three months; (10) any bleeding event of CTCAE5.0 grade 3 or above occurred within 4 weeks before screening; (11) previous history of organ transplantation; (12) Arterial/venous thrombosis events occurred within one year before screening, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis (except for venous thrombosis caused by venous catheterization due to previous chemotherapy, which was judged to be cured by the investigator), and pulmonary embolism. (13) those who have a history of psychotropic drug abuse and cannot abstain from it or have mental disorders; (14) a history of immunodeficiency, other acquired or congenital immunodeficiency diseases, or organ transplantation; (15) concomitant diseases that seriously endanger patient safety or affect the completion of the study according to the judgment of the investigator; (16) patients who did not meet the inclusion criteria or who were deemed by the investigator to be unsuitable for trial entry. 2. Control group (1) The histopathological diagnosis could not be obtained, and the indications for postoperative radiotherapy were unclear; (2) WHO grade 3-4 gliomas except WHO grade 3 oligodendroglioma; (3) The primary lesion was located in the thalamus or brain stem, or the maximum diameter of the postoperative residual lesion was greater than 3cm; (4) Spinal cord MR or cerebrospinal fluid examination showed evidence of spinal cord dissemination; (5) patients with other malignant tumors at the same time, except those with cured or stable malignant tumors; (6) previous history of brain radiotherapy; (7) patients under 18 years old; (8) pregnant or lactating women; (9) previous history of organ transplantation; (10) Arterial/venous thrombosis events within one year before screening, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis (except those who were cured by investigator's assessment due to venous catheterization due to previous chemotherapy), and pulmonary embolism; (11) those who have a history of psychotropic drug abuse and cannot abstain from it or have mental disorders; (12) a history of immunodeficiency, other acquired or congenital immunodeficiency diseases, or organ transplantation; (13) patients who did not meet the inclusion criteria or were considered by the investigator to be unsuitable for the follow-up cohort.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in the volume of brain functional areas exposed to radiation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Average reduced mean dose of radiation to brain functional areas;Evaluation of motor, language and memory functions;Quality of life (QoL);Recurrence rate;Overall survival (OS); | — |
Countries
China
Contacts
Public ContactZhirui Zhou
Huashan Hospital, Shanghai Medical College, Fudan University
Outcome results
None listed