Meningeoma
Conditions
Interventions
Treatment group:Hypofractionated radiotherapy based on linear accelerators (48-52.5 Gy/15Fx)
Control group:Conventional fractionated radiotherapy (54-60Gy/30Fx)
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18 - 70 years old; 2. Newly diagnosed WHO grade 2 or 3 meningioma with a clear pathological histological diagnosis, according to the 2021 WHO classification of central nervous system tumors; 3. WHO grade 2 meningioma that has not reached Simpson I grade resection, including: Simpson II-III grade resection, subtotal resection, partial resection or only biopsy; 4. Although it has achieved Simpson I grade total resection, it is accompanied by other high recurrence risk WHO grade 2 meningiomas, such as Ki-67 index greater than 10%, tumor invasion of brain tissue, tumor invasion of skull, TERT mutation, CDKN2A/B deletion, etc.; 5. WHO grade 3 meningioma, regardless of the extent of surgical resection; 6. At least 4 - 6 weeks after surgery or more, with good postoperative wound recovery, no obvious subcutaneous effusion; 7. KPS >= 70 points within 2 weeks before radiotherapy; 8. Good function of major organs, and the examination indicators meet the following requirements: 8.1 Blood routine examination: Hemoglobin >= 90 g/L (no blood transfusion within 14 days); Neutrophil count >= 1.5 × 10^9/L; Platelet count >= 80 × 10^9/L; 8.2 Biochemical examination: Total bilirubin = 50 ml/min (Cockcroft-Gault formula); 9. Before radiotherapy, the patient needs to undergo magnetic resonance examination, including T1, T1 enhanced, T2/T2flair, for postoperative residual lesions and disease assessment and fusion with positioning CT to delineate radiotherapy target areas. This study does not require that the patient must have assessable residual lesions. For patients with complete total resection considered to have medium to high recurrence risk, they meet the inclusion criteria of this study. 10. The patient and their family members need to sign the informed consent form; 11. Good compliance, and the patient and their family members agree to cooperate in long-term follow-up.
Exclusion criteria
Exclusion criteria: 1. Recurrent meningiomas, such as those that recur after surgery, or those that recur after SRS and subsequent reoperation; 2. Primary lesion located in the thalamus, brainstem, optic nerve sheath meningiomas, spinal cord or other extracranial meningiomas, multiple meningiomas, hemangiopericytomas, metastatic meningiomas; 3. The time from surgery to the start of radiotherapy is expected to exceed 16 weeks; 4. Initial treatment involved other meningioma-related therapies other than surgery; 5. Previous radiotherapy to the brain and skull; 6. Pregnant or lactating female patients; 7. Participated in other clinical trials within the past 6 months; 8. WHO 1 grade meningiomas, regardless of whether they are totally resected; 9. Any serious events reaching grade 3 or above as assessed in accordance with CTCAE 5.0 criteria occurred within 4 weeks before screening; 10. Suffering from other malignant tumors, but excluding those that have been cured or are in a stable state; 11. Imaging shows that the tumor has invaded important blood vessels or the researcher judges that the patient's tumor has a very high possibility of invading important blood vessels during treatment and causing fatal massive hemorrhage; 12. Abnormal coagulation function (PT > 16s, APTT > 43s, TT > 21s, Fbg < 2g/L), with a tendency to bleed (before randomization, INR must be within the normal range in the absence of anticoagulants within 14 days); 13. Had a thromboembolic event within the past year, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis (if the venous catheterization was performed due to previous chemotherapy and the venous thrombosis has been judged to have healed by the researcher), and pulmonary embolism, etc.; 14. Have a history of substance abuse of psychotropic drugs and are unable to quit or have mental disorders; 15. Have a history of immunodeficiency diseases, or have other acquired or congenital immune deficiency diseases, or have a history of organ transplantation; 16. According to the researcher's judgment, there are serious accompanying diseases that endanger the patient's safety or affect the patient's ability to complete the study; 17. Do not meet the inclusion criteria, or the researcher considers that the patient is not suitable for entering the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS);Quality of Life (QoL);Cognitive Function Score;Adverse Reaction; | — |
Countries
China
Contacts
Public ContactZhirui Zhou
Huashan Hospital, Shanghai Medical College, Fudan University
Outcome results
None listed