This phase III trial compares post-surgical surveillance to post-surgical radiation therapy for improving survival without disease progression in clinically low-risk patients with a grade 1 meningioma that is new or that has come back after a period of improvement (recurrent) or a new grade 2 meningioma who have undergone surgery. Post-surgical surveillance involves closely watching a patient's condition but not giving treatment unless there are changes in test results. Active surveillance avoids problems that may be caused by treatments such as radiation or surgery. It is used to find early signs that the condition is getting worse. During active surveillance, patients will be given certain exams and tests done on a regular schedule. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. The usual approach for low grade and low clinical risk meningiomas is surgery followed by radiation or no further treatment (observation) based on clinical risk factors such as tumor grade and the amount of tumor able to be removed. Clinical factors such as meningioma grade and the amount of meningioma that was removed help doctors decide whether radiation or observation is better after surgery. In this study, a patient's molecular risk, as determined using biomarkers, is also considered when assigning treatment. For patients with grade 1 or 2 meningiomas with a low clinical risk but high molecular risk of growing or coming back after surgery, this study will compare the usual approach of post-surgery observation to another usual approach of post-surgery radiation. Using high molecular risk to decide usual treatment and receiving the usual radiation could increase the amount of time without the tumor growing or coming back, but it could also cause side effects. For patients with grade 1 or 2 meningiomas with a low clinical risk and low molecular risk of growing or coming back after surgery, this study will evaluate if using molecular risk shows a greater benefit of the usual post-surgery observation.
Radiologically confirmed newly diagnosed or recurrent solitary (n=1) cranial World Health Organization (WHO) grade 1 meningioma post GTR or STR based on postoperative MRI findings, or newly diagnosed solitary WHO grade 2 meningioma post GTR based on postoperative MRI findings at the enrolling institution. Somatostatin receptor (SSTR)-directed positron emission tomography (PET) imaging may not be used to define extent of resection or meningioma number
Histologically confirmed as WHO grade 1 or 2, based on pathology findings at the enrolling institution according to WHO 2021 criteria
GTR is defined as the absence of gross residual meningioma, as confirmed by postoperative MRI
STR is defined as the presence of gross residual meningioma, as confirmed by postoperative MRI
None
Parallel
Patient Observation
Other interventionUndergo surveillance
Magnetic Resonance Imaging
Procedure/SurgeryUndergo MRI
Biospecimen Collection
Procedure/SurgeryUndergo collection of plasma, serum, and blood samples
Intensity-Modulated Radiation Therapy
RadiationUndergo IMRT
Intensity-Modulated Proton Therapy
Procedure/SurgeryUndergo IMPT
Fractionated Stereotactic Radiation Therapy
RadiationUndergo FSRT
Neurocognitive Assessment
Other interventionAncillary studies
Questionnaire Administration
Other interventionAncillary Studies
Progression free survival (Cohort A)
The log-rank test will be used to test the difference in PFS between the arms. Will estimate progression free survival by arm using the method of Kaplan-Meier. Cox proportional hazards model will be used to estimate the treatment hazard ratio and 95% confidence interval.
Progression free survival (Cohort B)
A one-sided 5% level Wald test will be used to determine if the observed hazard for progression free survival is better than that specified under the null hypothesis. Will estimate progression free survival using the method of Kaplan-Meier. Greenwood's formula will be used to estimate the confidence intervals for 5-year progression free survival.
Overall survival (Cohort A)
Analysis for overall survival will consist of estimation of its distribution for each study arm via the Kaplan-Meier method and a stratified log-rank test. Additional analyses may consist of estimating the treatment hazard ratio via the Cox proportional hazards model adjusting for randomization stratification factors, evaluating whether the proportional hazards assumption holds or whether any treatment effect is notably time-varying, and evaluating for potential treatment by prognostic covariate interactions.
Overall survival (Cohort B)
Analysis for overall survival will consist of estimation of its distribution for each study arm via the Kaplan-Meier method and a stratified log-rank test. Additional analyses may consist of estimating the treatment hazard ratio via the Cox proportional hazards model adjusting for randomization stratification factors, evaluating whether the proportional hazards assumption holds or whether any treatment effect is notably time-varying, and evaluating for potential treatment by prognostic covariate interactions.
Time to next treatment (TTNT) (Cohort A)
Time to next treatment (TTNT) (Cohort A)
Incidence of adverse events (Cohort A)
Adverse events (AEs) will be graded according to Common Terminology Criteria for Adverse Events version 5.0. Comprehensive summaries of AEs by treatment arm will be generated and examined. Counts and frequencies of worst (highest score) AE per patient will be presented overall and by AE type category, separately by assigned treatment group. The proportion of patients with at least one grade 3 or higher AE will be compared between treatment arms. Any frequencies to be tested will be evaluated using the chi-square or exact test as appropriate, with two-sided significance level 0.05.
Progression free survival by sex
Estimates of the primary outcome treatment effect and the corresponding 95% confidence intervals will be provided by sex.
Progression free survival by race
Estimates of the primary outcome treatment effect and the corresponding 95% confidence intervals will be provided by race.
Progression free survival by ethnicity
Estimates of the primary outcome treatment effect and the corresponding 95% confidence intervals will be provided by ethnicity.
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