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Active, not recruitingNCT03180268Updated Oct 2, 2026

Observation or Radiation Therapy in Treating Patients With Newly Diagnosed Grade II Meningioma That Has Been Completely Removed by Surgery

A Phase 3 interventional study of Biospecimen Collection and Clinical Observation in Grade 2 Meningioma and Intracranial Meningioma, sponsored by NRG Oncology. Active, not recruiting at 215 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-02.

Sponsored by NRG Oncology · Phase 3, Interventional, and Treatment

Updated Oct 2, 2026Now Active, not recruitingEnrollment updatedGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
162
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 129 studies in Meningioma with a site in United States — 27 open to participants now, 39 under way, 1 of them phase 3. Meningioma · United States.

Enrollment
9th of 107
162 · median 30
Started
2017
with 7 others
Phase 3
6 of 129
none open now
Primary completion
2027-06
later than 13 of 37 live
Registered
85th of 129
by date

Among the 129 studies in Meningioma with a site in United States, this one is the 9th largest by enrollment of the 107 interventional ones that give a count, is one of 8 that started in 2017, is one of 6 in phase 3, reaches primary completion later than 13 of the 37 other live ones, and was the 85th registered.

Meningioma

255 studies on the registry are indexed under Meningioma; 85 are open to participants now.

Browse Meningioma studies →

Open to participants now

27 of the 129 studies in Meningioma with a site in United States are open now. Recruiting first, the newest first:

22 more — sign in →

All 27 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 66 Meningioma studies recruiting now, 43 (65%) set no upper age limit and 9 (14%) stop at 75 or younger; 8 take children under 18; 6 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 129 studies in Meningioma with a site in United States, or all of them as a file.
02

Study summary

This randomized phase III trial studies how well radiation therapy works compared with observation in treating patients with newly diagnosed grade II meningioma that has been completely removed by surgery. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors.

Read the detailed description

PRIMARY OBJECTIVE:

I. To determine the extent of clinical benefit of the addition of adjuvant radiotherapy (RT) to gross total resection (GTR) for patients with newly diagnosed World Health Organization (WHO) grade II meningioma.

SECONDARY OBJECTIVES:

I. Overall survival (OS). II. Disease-specific survival (DSS). III. Toxicity (grade 3+, exclusive of expected alopecia). IV. Neurocognitive function (NCF). V. Patient reported outcomes (PRO) measurements. VI. Adherence to protocol-specific target and normal tissue parameters. VII. Concordance measurements of central versus parent-institution pathology. VIII. Assessment of pHH3 mitotic index and its correlation with progression-free survival (PFS) and OS.

IX. Validation of the prognostic value of a 34-gene expression biomarker. X. Validation of the predictive value of a 34-gene expression biomarker in predicting the benefit of radiotherapy.

XI. Tissue and specimen collection for future translational research.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo observation. Additionally, patients undergo magnetic resonance imaging (MRI) and blood collection throughout the study.

ARM II: Patients undergo intensity-modulated radiation therapy (IMRT) or proton beam radiation therapy 5 days a week over 6.5-7 weeks for a total of 33 fractions in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo MRI and blood collection throughout the study.

After completion of study treatment, patients are followed up at 3, 6, and 12 months, every 6 months for year 2 and 3, then yearly for 10 years.

03

Conditions studied

  • Grade 2 Meningioma
  • Intracranial Meningioma

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04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • PRIOR TO STEP 1 REGISTRATION:
  • The patient must have a newly diagnosed unifocal intracranial meningioma, gross totally resected, and confirmed as WHO grade II based upon pathology findings at the enrolling institution. WHO grade will be assigned according to WHO 2016 criteria
  • Gross total resection (GTR) will be interpreted as modified Simpson grade 1-3 without gross residual dural-based or extradural tumor. GTR must be confirmed both by modified Simpson grade and by post-operative magnetic resonance imaging (MRI) findings. The modified Simpson grade can be inferred from the operative report (surgeon does not need to explicitly describe the Simpson grade for the purposes of eligibility)
  • Step 1 registration must occur within 180 days of the initial surgery; this will provide sufficient time for post-operative imaging confirmation of resection extent after resolution of operative changes. Moreover, it will permit additional surgery if needed to achieve a GTR. Within this 180 day interval, a second surgery is permitted in order to achieve GTR, but even with a second surgery, Step 1 registration must occur within 180 days of the initial resection
  • GTR must be confirmed on post-operative imaging following the most recent surgery. For protocol enrollment, the assessment of GTR will be made at each site. However, submission of both pre-operative and post-operative MRIs is required for patients. If a second surgery is performed, submission of post-operative MRI is required and pre-operative MRI is required only if obtained. All sequences obtained in the pre- and post-operative MR imaging are to be submitted to National Radiology Group (NRG) Oncology for study registration. The post-operative MRI must be completed within sufficient time to permit step 1 registration within 180 days of the initial resection. These same conditions apply in the setting of a second surgical procedure, although if a second surgery is completed, step 1 registration must still occur with 180 days of initial surgery. Computed tomography (CT) imaging is not required, but may be obtained if desired clinically, for instance to assess calcifications or hyperostosis
  • The patient or a legally authorized representative must provide study-specific prior to study entry
  • NOTE: Central pathology review must occur between steps 1 and 2 of registration. Once appropriate pathology specimens are received, central pathology review will occur within 10 business days, and must confirm WHO grade II meningioma before the patient can proceed to step 2 registration and randomization
  • PRIOR TO STEP 2 REGISTRATION:
  • Histologically confirmed diagnosis of WHO grade II meningioma confirmed by central pathology review prior to step 2 registration
  • Age >= 18
  • History/physical examination, including neurologic examination within 60 days prior to step 2 registration
  • Post-operative Zubrod performance status 0-1 within 60 days prior to step 2 registration
  • If the patient is a woman is of , a serum pregnancy test, obtained within 14 days prior to step 2 registration, must be negative, and, if randomized to receive radiation therapy, the woman must agree to use

Exclusion criteria

Exclusion Criteria:

  • Optic nerve sheath meningioma, spinal or other extracranial meningioma, multiple meningiomas, hemangiopericytoma
  • Definitive evidence of meningioma (metastasis, although rare, can occur and is exclusionary)
  • Prior invasive (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (carcinoma in situ of the breast, oral cavity, cervix, melanoma in situ, or other non-invasive malignancies are permissible)
  • Previous radiotherapy to the scalp, cranium, brain, or skull base and radiation-induced meningiomas

  • Major medical illnesses or psychiatric impairments, which in the investigators opinion, will prevent administration or completion of the protocol therapy and/or preclude ; these include, but are not restricted to:

    • Unstable angina and/or congestive heart failure requiring hospitalization at the time of step 2 registration
    • Transmural myocardial infarction within the last 6 months prior to step 2 registration
    • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of step 2 registration
    • exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of step 2 registration
    • Type II neurofibromatosis (NF2)
    • Ailments entailing substantial increases in sensitivity and side effect risk from radiation therapy (ataxia telangiectasia, Nijmegen breakage syndrome, and (HIV) with \< 200 cells/microliter); HIV testing is not required for eligibility for this protocol, and known HIV positive patients are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count >= 200 cells/microliter within 30 days prior to step 2 registration
    • Inability to undergo MRI with and without contrast (e.g. claustrophobia, non-MRI compatible implant or foreign body, gadolinium allergy or renal dysfunction preventing the patient from receiving gadolinium- institutional guidelines should be used to determine if patients are at risk for renal dysfunction). Note that patients with severe claustrophobia are permitted on this study if they are willing and able to undergo MRI with adequate sedation or anesthesia
Terms in these criteria, in plain language(9)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

CD4 count

The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
162 participants (actual)

Study arms

  • Active comparator
    Arm I (observation)

    Patients undergo observation. Additionally, patients undergo MRI and blood collection throughout the study.

    Procedure: Biospecimen Collection · Other: Clinical Observation · Other: Laboratory Biomarker Analysis · Procedure: Magnetic Resonance Imaging · Other: Quality-of-Life Assessment

  • Experimental
    Arm II (radiation therapy)

    Patients undergo IMRT or proton beam radiation therapy 5 days a week over 6.5-7 weeks for a total of 33 fractions in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo MRI and blood collection throughout the study.

    Procedure: Biospecimen Collection · Radiation: Intensity-Modulated Radiation Therapy · Other: Laboratory Biomarker Analysis · Procedure: Magnetic Resonance Imaging · Radiation: Proton Beam Radiation Therapy · Other: Quality-of-Life Assessment

Interventions

  • ProcedureBiospecimen Collection

    Undergo collection of blood samples

    Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

  • OtherClinical Observation

    Undergo observation

    Also known as: observation

  • RadiationIntensity-Modulated Radiation Therapy

    Undergo IMRT

    Also known as: IMRT, Intensity modulated radiation therapy (procedure), Intensity Modulated RT, Intensity-Modulated Radiotherapy, Radiation, Intensity-Modulated Radiotherapy

  • OtherLaboratory Biomarker Analysis

    Correlative studies

  • ProcedureMagnetic Resonance Imaging

    Undergo MRI

    Also known as: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI

  • RadiationProton Beam Radiation Therapy

    Undergo proton beam radiation therapy

    Also known as: External beam radiation therapy protons (procedure), External Beam Radiotherapy (protons), PBRT, Proton, Proton EBRT, Proton External Beam Radiotherapy, Proton Radiation Therapy, PROTON Therapy, Radiation, Proton Beam

  • OtherQuality-of-Life Assessment

    Ancillary studies

    Also known as: Quality of Life Assessment

06

What researchers measure

Primary outcomes

  1. Progression free survival (PFS)

    Kaplan-Meier method will be used to calculate the PFS rates for each of the two arms. Hazard ratio (HR) on the treatment effect will be calculated using the Cox proportional hazard model. A one-sided log-rank test will be used to test the difference in PFS between the two arms.

    Time frame: From randomization to the first documented disease progression, or death due to any cause, whichever comes first, assessed up to 10 years

Secondary outcomes

  1. PFS

    Will be calculated based on the Kaplan-Meier curve. Cox proportional hazard model will be used to determine the adjusted treatment effect on PFS, with patient pretreatment characteristics as covariates.

    Time frame: From randomization to the first documented disease progression, or death due to any cause, whichever comes first, assessed at 3 years

  2. PFS

    Will be calculated based on the Kaplan-Meier curve. Cox proportional hazard model will be used to determine the adjusted treatment effect on PFS, with patient pretreatment characteristics as covariates.

    Time frame: From randomization to the first documented disease progression, or death due to any cause, whichever comes first, assessed up to 5 years

  3. Disease-specific survival (DSS)

    Will be calculated using the cumulative incidence function for each arm. The HR for the treatment effect on DSS will be calculated using Gray's method under the competing risk approach, with death due to non-disease related cause treated as the competing risk. Multivariate analysis on DSS will be performed using the Fine-Gray model, with patient pretreatment characteristics as covariates.

    Time frame: From randomization to disease-related death, assessed up to 10 years

  4. DSS rates

    Will be calculated using the cumulative incidence function for each arm. The HR for the treatment effect on DSS will be calculated using Gray's method under the competing risk approach, with death due to non-disease related cause treated as the competing risk. Multivariate analysis on DSS will be performed using the Fine-Gray model, with patient pretreatment characteristics as covariates.

    Time frame: At 3 years

  5. DSS rates

    Will be calculated using the cumulative incidence function for each arm. The HR for the treatment effect on DSS will be calculated using Gray's method under the competing risk approach, with death due to non-disease related cause treated as the competing risk. Multivariate analysis on DSS will be performed using the Fine-Gray model, with patient pretreatment characteristics as covariates.

    Time frame: At 5 years

  6. Overall survival (OS)

    Cox proportional hazard model will be used to determine the adjusted treatment effect on OS, with patient pretreatment characteristics as covariates.

    Time frame: From randomization to death due to any cause, assessed up to 10 years

  7. OS rates

    Will be calculated based on the Kaplan-Meier curve. Cox proportional hazard model will be used to determine the adjusted treatment effect on OS, with patient pretreatment characteristics as covariates.

    Time frame: At 5 years

  8. Incidence of adverse events (exclusive of alopecia)

    Will be measured by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4 (version 5 beginning April 5, 2018).

    Time frame: Up to 3 years

  9. Adherence rate to protocol-specific target and normal tissue parameters

    Time frame: Up to 10 years

  10. Concordance rate of central versus parent-institution pathology

    Time frame: Up to 10 years

  11. Prognostic value of 34-gene expression biomarker

    Will generate Kaplan-Meier curves for different risk subgroups defined by the risk scores, separately for post-operative observation and post-operative radiotherapy arms. The log-rank test will be used to test the difference in clinical outcomes (PFS and OS) between molecular risk subgroups (separately for the post-operative observation arm and post-operative radiotherapy arm). Cox proportional hazard model will be used to estimate the prognostic effect of the gene expression defined risk groups on clinical outcomes adjusting for pre-treatment patient characteristics as well as treatment arm.

    Time frame: Up to 5 years

  12. Predictive value of 34-gene expression biomarker

    Will be evaluated formally through the test of a statistical interaction between molecular risk group (low/intermediate versus high) and treatment (observation versus radiotherapy). The Kaplan-Meier curves of PFS and OS between treatment arms will be displayed separately among low/intermediate risk and high-risk groups. A Cox proportional hazards model will be built including treatment group, gene expression risk group, an interaction term between treatment and gene expression risk group, as well as other pre-treatment patient characteristics. The interaction test will be based on a two-sided 0.05 level Wald test in the Cox proportional hazards model. The treatment difference between radiation therapy and observation will also be tested within each gene expression risk subgroup in a multivariable Cox proportional hazards model, adjusting for other patient characteristics.

    Time frame: Up to 5 years

  13. Change in neurocognitive function (NCF) assessed by MD Anderson Symptom Inventory with Brain Tumor (MDASI-BT)

    Will use a 2-sample t-test with a one-sided significance level of 0.05, with a Bonferroni adjustment to account for the neurocognitive function and symptom assessments resulting in an overall type I error of 0.1, there will be 72% statistical power to detect a medium effect size of 0.5 standard deviation (SD) for a comparison of the change from baseline to 6 months after randomization between the experimental and the control arm. Will compare NCF outcomes between IMRT to proton therapy.

    Time frame: Baseline up to 60 months

  14. Change in patient reported outcomes (PRO) as assessed by MDASI-BT

    Will use a 2-sample t-test with a one-sided significance level of 0.05, with a Bonferroni adjustment to account for the neurocognitive function and symptom assessments resulting in an overall type I error of 0.1, there will be 72% statistical power to detect a medium effect size of 0.5 standard deviation for a comparison of the change from baseline to 6 months after randomization between the experimental and the control arm. Will compare PRO outcomes between IMRT to proton therapy.

    Time frame: Baseline up to 60 months

07

Study locations

215 sites

Showing the first 100 of 215 sites across 5 countries. Choose a country and city above to see the rest.

08

References and documents

Individual participant data

Plan to share: 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.

Data sharing details ↗ · grants.nih.gov

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Sep 2017 (actual). Primary completion is estimated for Jun 2027, 117 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 6, 2017
First posted
Jun 8, 2017
StartActual
Sep 12, 2017
Primary completionEst.
Jun 15, 2027
CompletionEst.
Jun 15, 2032
Last update
Oct 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Active, not recruiting
changed Oct 2, 2026
Enrollment
163 (estimated)→162 (actual)
Oct 2, 2026
Show all 1 update
  1. Oct 2, 2026
    Recruiting→Active, not recruiting
    Enrollment 163 (estimated)→162 (actual)
    + 2 other changes: site details and contact details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT03180268
Lead sponsor
NRG Oncology
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Jun 8, 2017
Start date
Sep 12, 2017
Primary completion
Jun 15, 2027 (estimated)
Completion
Jun 15, 2032 (estimated)
Last update
Oct 2, 2026

Study contacts

Michael A Vogelbaum
principal investigator · NRG Oncology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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