Grade 1 MeningiomaPhase 3NCT07785687
Comparing Radiation After Surgery to Observation After Surgery in Patients With Clinical Low-Risk, Molecular High-Risk Meningioma, and Evaluating Observation After Surgery in Patients With Clinical and Molecular Low-Risk Meningioma
A Phase 3 study testing Patient Observation, Magnetic Resonance Imaging and Biospecimen Collection in people with Grade 1 Meningioma and Grade 2 Meningioma, run by NRG Oncology.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Grade 1 Meningioma, Grade 2 Meningioma, Recurrent Grade 1 Meningioma
- What is being tested?
- Patient Observation, Magnetic Resonance Imaging and Biospecimen Collection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 464 participants
- Where
- No sites listed yet
- Study dates
- 28 Jan 2027to 30 Jun 2040
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Initial surgery (GTR or STR) within 180 days prior to step 1 registration (within this 180-day period, a second surgery is permitted to achieve GTR):
- 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
- Surgeon-reported Simpson grade of resection, meningioma location, and any available SSTR-directed PET imaging studies will be assembled
Show all 21Show fewer
- Postoperative MRI prior to step 1 registration. It is additionally required that all imaging sequences obtained in all preoperative and postoperative MRI, and any computed tomography (CT) or SSTR-direct PET imaging studies used for radiotherapy planning be submitted to NRG Oncology after step 1 registration. SSTR PET imaging may be used for radiotherapy planning to ensure all disease is encompassed in the clinical target volume (CTV) but may not be used to shrink the CTV or to supersede MRI-defined extent of resection or meningioma number
- NOTE: Central review for pathology, radiology, and gene expression profiling must occur between step 1 and step 2 of registration. Once appropriate pathology and imaging data are received, central pathology and radiology review will occur within 10 business days and must confirm WHO grade 1 meningioma after GTR or STR or WHO grade 2 meningioma after GTR. Gene expression profiling will occur within 30 business days of receiving appropriate pathology specimens. Central review for pathology, radiology, and gene expression must be completed before the patient can proceed to step 2 registration/randomization. For patients with central confirmation of clinical low-risk, molecular high-risk meningioma who will be eligible for cohort A randomization, central determination of 54 gray (Gy)/30 fractions (Fx) or 25Gy/5Fx radiotherapy and recommended radiotherapy treatment volumes will be provided prior to step 2 registration. See the study-specific biospecimen collection and submission manual on the Cancer Trials Support Unit (CTSU) protocol website for details of central pathology review and gene expression biomarker testing
- Age ≥ 18
- Central radiology confirmation of solitary (n=1) cranial meningioma on preoperative MRI and extent of resection (GTR or STR) on postoperative MRI
- Central histological pathology confirmation of newly diagnosed or recurrent WHO grade 1 meningioma after GTR or STR, or newly diagnosed WHO grade 2 meningioma after GTR, according to WHO 2021 criteria
- Central gene expression profiling for calculation of the gene expression risk score:
- Cohort A: High gene expression risk score after GTR or STR, or intermediate gene expression risk score after STR
- Cohort B: Low gene expression risk score after GTR or STR, or intermediate gene expression risk score after GTR
- Postoperative Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Not pregnant and not nursing
- Negative urine or serum pregnancy test (in persons of childbearing potential) within 14 days prior to step 2 registration. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) and who is not postmenopausal
- No prior high dose radiotherapy within the last 10 years to the region of the study tumor that would result in overlap of radiotherapy fields will be allowed. High dose radiotherapy is defined as an EQD2 of 45Gy or higher, as calculated with an alpha/beta ratio of 3. Patients with known or suspected radiation-induced meningioma are eligible
- New York Heart Association Functional Classification II or better (New York Heart Association [NYHA] Functional Classification III/IV are not eligible) (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification)
- No active infection currently requiring intravenous (IV) antibiotic management
- No known history of meningioma predisposition syndrome, such as neurofibromatosis type 2 (testing is not required)
Who cannot join
- -
About this study
Official title: A Randomized Phase 3 Clinical Trial of Postoperative Radiotherapy Versus Postoperative Surveillance for Clinical Low-Risk, Molecular High-Risk Meningioma and Longitudinal Surveillance for Clinical and Molecular Low-Risk Meningioma
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.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine if progression free survival (PFS) is improved with postoperative radiotherapy compared to postoperative surveillance for patients with clinical low-risk, molecular high-risk meningiomas, as defined using a centralized 34-gene expression biomarker and centralized neuro-radiology review. (Cohort A) II. To determine if 5-year PFS is greater than 90% with postoperative surveillance for patients with clinical and molecular low-risk meningiomas, as defined using a centralized 34-gene expression biomarker and centralized neuro-radiology review. (Cohort B)
SECONDARY OBJECTIVES:
- To determine if overall survival (OS) of patients with clinical low-risk, molecular high-risk meningiomas is improved with postoperative radiotherapy compared to postoperative surveillance. (Cohort A) II. To determine if the time-to-next-treatment of patients with clinical low-risk, molecular high-risk meningiomas is improved with postoperative radiotherapy compared to postoperative surveillance. (Cohort A) III. To define the safety and tolerability of postoperative radiotherapy for patients with clinical low-risk, molecular high-risk meningiomas using Common Terminology Criteria for Adverse Events (CTCAE) 5.0. (Cohort A) IV. To determine if postoperative radiotherapy leads to increased neurocognitive function (NCF) deterioration, as assessed by the Hopkins Verbal Learning Test-Revised (HVLT-R), the Controlled Oral Word Association Test (COWA), and the Trail Making Tests (TMT) A and B, as compared to postoperative surveillance for patients with clinical low-risk, molecular high-risk meningiomas. (Cohort A) V. To determine if postoperative radiotherapy leads to increased patient-reported neurological symptom burden, as measured by the MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) module, as compared to postoperative surveillance for patients with clinical low-risk, molecular high-risk meningiomas. (Cohort A) VI. To define the OS of patients with clinical and molecular low-risk meningiomas with postoperative surveillance. (Cohort B) VII. To define the safety profile of postoperative surveillance for patients with clinical and molecular low-risk meningiomas using CTCAE 5.0. (Cohort B)
EXPLORATORY OBJECTIVE:
- To explore additional biomarkers in pre-treatment tumor tissue, blood, or serum that may elucidate the efficacy, safety, or tolerability of postoperative radiotherapy compared to postoperative surveillance.
OUTLINE: Patients with a high gene expression risk score after gross total resection (GTR) or subtotal resection (STR) or intermediate gene expression risk score after STR (Cohort A) are randomized to 1 of 2 arms. Patients with low gene expression risk score after GTR or STR or intermediate gene expression risk score after GTR (Cohort B) are assigned to Arm I.
ARM I: Patients undergo surveillance on study. Patients also undergo magnetic resonance imaging (MRI) throughout the trial and undergo collection of plasma, serum, and blood samples on study.
ARM II: Patients undergo intensity-modulated radiation therapy (IMRT) or intensity-modulated proton therapy (IMPT) 5 days per week for a total of 30 fractions over 50 days or undergo fractionated stereotactic radiation therapy (FSRT) for a total of 5 fractions over 10 days in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI and collection of plasma, serum, and blood samples throughout the trial.
After completion of study treatment, patients are followed up at 3, 6, and 12 months, every 6 months in years 2 and 3, and then yearly in years 4 and 5.
- Being tested
- Patient Observation, Magnetic Resonance Imaging, Biospecimen Collection, Intensity-Modulated Radiation Therapy, Intensity-Modulated Proton Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient ObservationOther
Undergo surveillance
Magnetic Resonance ImagingProcedure or surgery
Undergo MRI
Biospecimen CollectionProcedure or surgery
Undergo collection of plasma, serum, and blood samples
Intensity-Modulated Radiation TherapyRadiation
Undergo IMRT
Intensity-Modulated Proton TherapyProcedure or surgery
Undergo IMPT
Fractionated Stereotactic Radiation TherapyRadiation
Undergo FSRT
Neurocognitive AssessmentOther
Ancillary studies
Questionnaire AdministrationOther
Ancillary Studies
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 Postoperative Surveillance | Experimental | Patients undergo surveillance on study. Patients also undergo MRI throughout the trial and undergo collection of plasma, serum, and blood samples on study. Receives: Other: Patient Observation; Procedure: Magnetic Resonance Imaging; Procedure: Biospecimen Collection |
| Arm II Postoperative Radiotherapy | Experimental | Patients undergo IMRT or IMPT 5 days per week for a total of 30 fractions over 50 days or undergo FSRT for a total of 5 fractions over 10 days in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI and collection of plasma, serum, and blood samples throughout the trial. Receives: Procedure: Magnetic Resonance Imaging; Procedure: Biospecimen Collection; Radiation: Intensity-Modulated Radiation Therapy; Procedure: Intensity-Modulated Proton Therapy; Radiation: Fractionated Stereotactic Radiation Therapy; Other: Neurocognitive Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From randomization until the first documented disease progression or death, assessed up to 5 years
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.
Measured: From randomization until the first documented disease progression or death, assessed up to 5 years
Secondary outcomes (7)
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.
Measured: From randomization until death due to any cause, assessed up to 5 years
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.
Measured: From randomization until death due to any cause, assessed up to 5 years
Time to next treatment (TTNT) (Cohort A)
Time to next treatment (TTNT) (Cohort A)
Measured: From randomization until reoperation in the prior surgical bed or prior radiotherapy field, re-irradiation in the prior surgical bed or radiotherapy field, or initiation of systemic meningioma-directed medical therapy, assessed up to 5 years
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.
Measured: At months 3, 6, and 12 for the first year then every 6 months for year 2
Incidence of adverse events (Cohort B)
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.
Measured: At months 3, 6, and 12 for the first year then every 6 months for year 2
Patient-reported neurological symptom burden (Cohort A)
Will determine whether postoperative radiotherapy increases patient-reported neurological symptom burden compared with postoperative surveillance in patients with clinical low-risk, molecular high-risk meningiomas. Neurological symptom burden will be assessed using the MD Anderson Symptom Inventory-Brain Tumor (MDASI-BT) module, a patient-reported outcome measure in which symptom severity items are scored on a 0 to 10 numeric rating scale, where 0 = symptom not present and 10 = symptom as bad as imaginable. Higher scores indicate greater symptom burden (worse outcome). For the primary analysis evaluating between-arm differences in MDASI-BT scores over time, a general mixed-effects model for repeated measures will be fitted to assess changes in scores by treatment arm.
Measured: Every 12 months for 5 years
Neurocognitive function (Cohort A)
Neurocognitive function will be assessed using the Trail Making Test (TMT), a measure of attention, processing speed, and executive function. Neurocognitive failure will be defined according to the protocol-specified criteria for deterioration from baseline on the TMT. TTNCF analyses will be performed as described above. TMT performance is typically measured as completion time in seconds; lower completion times indicate better neurocognitive performance and higher values indicate worse performance.
Measured: Every 12 months for 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start28 Jan 2027 (estimated)
- Primary completion30 Jun 2035 (estimated)
- Study completion30 Jun 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Grade 1 MeningiomaStudies of the same condition, open and under way.
- More trials run by NRG OncologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 464 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NRG Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07785687
- Sponsor's protocol ID
- NRG-BN015
- Other IDs
- NCI-2026-05558
- Status last verified
- Aug 2026
- First submitted
- 13 Aug 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase 3 Clinical Trial of Postoperative Radiotherapy Versus Postoperative Surveillance for Clinical Low-Risk, Molecular High-Risk Meningioma and Longitudinal Surveillance for Clinical and Molecular Low-Risk Meningioma
- ClinicalTrials.gov ID
- NCT07785687
- Acronym / sponsor ID
- NRG-BN015
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 464 participants (estimated)
- Lead sponsor
- NRG OncologyUniversity, hospital or other
- Study start
- 28 Jan 2027 (estimated)
- Primary completion
- 30 Jun 2035 (estimated)
- Study completion
- 30 Jun 2040 (estimated)
- First posted
- 25 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- To determine if progression free survival (PFS) is improved with postoperative radiotherapy compared to postoperative surveillance for patients with clinical low-risk, molecular high-risk meningiomas, as defined using a centralized 34-gene expression biomarker and centralized neuro-radiology review. (Cohort A) II. To determine if 5-year PFS is greater than 90% with postoperative surveillance for patients with clinical and molecular low-risk meningiomas, as defined using a centralized 34-gene expression biomarker and centralized neuro-radiology review. (Cohort B)
SECONDARY OBJECTIVES:
- To determine if overall survival (OS) of patients with clinical low-risk, molecular high-risk meningiomas is improved with postoperative radiotherapy compared to postoperative surveillance. (Cohort A) II. To determine if the time-to-next-treatment of patients with clinical low-risk, molecular high-risk meningiomas is improved with postoperative radiotherapy compared to postoperative surveillance. (Cohort A) III. To define the safety and tolerability of postoperative radiotherapy for patients with clinical low-risk, molecular high-risk meningiomas using Common Terminology Criteria for Adverse Events (CTCAE) 5.0. (Cohort A) IV. To determine if postoperative radiotherapy leads to increased neurocognitive function (NCF) deterioration, as assessed by the Hopkins Verbal Learning Test-Revised (HVLT-R), the Controlled Oral Word Association Test (COWA), and the Trail Making Tests (TMT) A and B, as compared to postoperative surveillance for patients with clinical low-risk, molecular high-risk meningiomas. (Cohort A) V. To determine if postoperative radiotherapy leads to increased patient-reported neurological symptom burden, as measured by the MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) module, as compared to postoperative surveillance for patients with clinical low-risk, molecular high-risk meningiomas. (Cohort A) VI. To define the OS of patients with clinical and molecular low-risk meningiomas with postoperative surveillance. (Cohort B) VII. To define the safety profile of postoperative surveillance for patients with clinical and molecular low-risk meningiomas using CTCAE 5.0. (Cohort B)
EXPLORATORY OBJECTIVE:
- To explore additional biomarkers in pre-treatment tumor tissue, blood, or serum that may elucidate the efficacy, safety, or tolerability of postoperative radiotherapy compared to postoperative surveillance.
OUTLINE: Patients with a high gene expression risk score after gross total resection (GTR) or subtotal resection (STR) or intermediate gene expression risk score after STR (Cohort A) are randomized to 1 of 2 arms. Patients with low gene expression risk score after GTR or STR or intermediate gene expression risk score after GTR (Cohort B) are assigned to Arm I.
ARM I: Patients undergo surveillance on study. Patients also undergo magnetic resonance imaging (MRI) throughout the trial and undergo collection of plasma, serum, and blood samples on study.
ARM II: Patients undergo intensity-modulated radiation therapy (IMRT) or intensity-modulated proton therapy (IMPT) 5 days per week for a total of 30 fractions over 50 days or undergo fractionated stereotactic radiation therapy (FSRT) for a total of 5 fractions over 10 days in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI and collection of plasma, serum, and blood samples throughout the trial.
After completion of study treatment, patients are followed up at 3, 6, and 12 months, every 6 months in years 2 and 3, and then yearly in years 4 and 5.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 Postoperative Surveillance | Experimental | Other: Patient Observation, Procedure: Magnetic Resonance Imaging, Procedure: Biospecimen CollectionPatients undergo surveillance on study. Patients also undergo MRI throughout the trial and undergo collection of plasma, serum, and blood samples on study. |
| Arm II Postoperative Radiotherapy | Experimental | Procedure: Magnetic Resonance Imaging, Procedure: Biospecimen Collection, Radiation: Intensity-Modulated Radiation Therapy, Procedure: Intensity-Modulated Proton Therapy, Radiation: Fractionated Stereotactic Radiation Therapy, Other: Neurocognitive Assessment, Other: Questionnaire AdministrationPatients undergo IMRT or IMPT 5 days per week for a total of 30 fractions over 50 days or undergo FSRT for a total of 5 fractions over 10 days in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI and collection of plasma, serum, and blood samples throughout the trial. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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
- Initial surgery (GTR or STR) within 180 days prior to step 1 registration (within this 180-day period, a second surgery is permitted to achieve GTR):
- Postoperative MRI prior to step 1 registration. It is additionally required that all imaging sequences obtained in all preoperative and postoperative MRI, and any computed tomography (CT) or SSTR-direct PET imaging studies used for radiotherapy planning be submitted to NRG Oncology after step 1 registration. SSTR PET imaging may be used for radiotherapy planning to ensure all disease is encompassed in the clinical target volume (CTV) but may not be used to shrink the CTV or to supersede MRI-defined extent of resection or meningioma number
- NOTE: Central review for pathology, radiology, and gene expression profiling must occur between step 1 and step 2 of registration. Once appropriate pathology and imaging data are received, central pathology and radiology review will occur within 10 business days and must confirm WHO grade 1 meningioma after GTR or STR or WHO grade 2 meningioma after GTR. Gene expression profiling will occur within 30 business days of receiving appropriate pathology specimens. Central review for pathology, radiology, and gene expression must be completed before the patient can proceed to step 2 registration/randomization. For patients with central confirmation of clinical low-risk, molecular high-risk meningioma who will be eligible for cohort A randomization, central determination of 54 gray (Gy)/30 fractions (Fx) or 25Gy/5Fx radiotherapy and recommended radiotherapy treatment volumes will be provided prior to step 2 registration. See the study-specific biospecimen collection and submission manual on the Cancer Trials Support Unit (CTSU) protocol website for details of central pathology review and gene expression biomarker testing
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient ObservationUndergo surveillance | Other | Arm 1 Postoperative Surveillance |
| Magnetic Resonance ImagingUndergo MRI | Procedure or surgery | Arm 1 Postoperative Surveillance, Arm II Postoperative Radiotherapy |
| Biospecimen CollectionUndergo collection of plasma, serum, and blood samples | Procedure or surgery | Arm 1 Postoperative Surveillance, Arm II Postoperative Radiotherapy |
| Intensity-Modulated Radiation TherapyUndergo IMRT | Radiation | Arm II Postoperative Radiotherapy |
| Intensity-Modulated Proton TherapyUndergo IMPT | Procedure or surgery | Arm II Postoperative Radiotherapy |
| Fractionated Stereotactic Radiation TherapyUndergo FSRT | Radiation | Arm II Postoperative Radiotherapy |
| Neurocognitive AssessmentAncillary studies | Other | Arm II Postoperative Radiotherapy |
| Questionnaire AdministrationAncillary Studies | Other | Arm II Postoperative Radiotherapy |
Primary outcome
Progression free survival (Cohort A)
Time frame: From randomization until the first documented disease progression or death, assessed up to 5 years
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)
Time frame: From randomization until the first documented disease progression or death, assessed up to 5 years
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.
7 secondary outcomes
Overall survival (Cohort A)
Time frame: From randomization until death due to any cause, assessed up to 5 years
Overall survival (Cohort B)
Time frame: From randomization until death due to any cause, assessed up to 5 years
Time to next treatment (TTNT) (Cohort A)
Time frame: From randomization until reoperation in the prior surgical bed or prior radiotherapy field, re-irradiation in the prior surgical bed or radiotherapy field, or initiation of systemic meningioma-directed medical therapy, assessed up to 5 years
Incidence of adverse events (Cohort A)
Time frame: At months 3, 6, and 12 for the first year then every 6 months for year 2
Incidence of adverse events (Cohort B)
Time frame: At months 3, 6, and 12 for the first year then every 6 months for year 2
Patient-reported neurological symptom burden (Cohort A)
Time frame: Every 12 months for 5 years
Neurocognitive function (Cohort A)
Time frame: Every 12 months for 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: Yes. NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Patient Observation, Magnetic Resonance Imaging and Biospecimen Collection in people with Grade 1 Meningioma and Grade 2 Meningioma, run by NRG Oncology.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (Cohort A) (time frame: From randomization until the first documented disease progression or death, assessed up to 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.