Comparing observation and radiation therapy for patients with grade II meningioma after surgery
Official title: Phase III Trial of Observation Versus Irradiation for a Gross Totally Resected Grade II Meningioma
Run by NRG Oncology · NCT03180268 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study is testing whether radiation therapy or just monitoring is better for patients who have had their grade II meningioma completely removed through surgery.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 163 (estimated) |
| Sponsor | NRG Oncology Academic / other |
| Drugs / interventions | radiation |
| Locations | 214 sites (Birmingham, Alabama and 213 other locations) |
| Trial ID | NCT03180268 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals with a newly diagnosed, unifocal, histologically confirmed grade II meningioma that has been completely resected.
✕Probably not a fit
Patients with grade II meningioma that has not been completely resected or those with other types of brain tumors may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase III trial investigates the effectiveness of radiation therapy versus observation in patients who have had a newly diagnosed grade II meningioma completely removed through surgery. Participants are randomly assigned to either receive radiation therapy or be monitored without immediate treatment. The study aims to assess various outcomes, including overall survival, disease-specific survival, and neurocognitive function, while also collecting tissue samples for future research. Patients will undergo regular MRI scans and blood tests throughout the trial to monitor their condition.
Why it matters
Potential benefit: If successful, this study could provide insights into the best post-surgical treatment options for patients with grade II meningioma, potentially improving survival rates and quality of life.
How similar studies have gone: Previous studies have explored the role of radiation therapy in similar contexts, showing promising results, but this specific approach is being rigorously tested in a randomized setting.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * PRIOR TO STEP 1 REGISTRATION: * The patient must have a newly diagnosed unifocal intracranial meningioma, gross totally resected, and histologically 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 informed consent 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 childbearing potential, 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 contraception Exclusion Criteria: * Optic nerve sheath meningioma, spinal or other extracranial meningioma, multiple meningiomas, hemangiopericytoma * Definitive evidence of metastatic meningioma (metastasis, although rare, can occur and is exclusionary) * Prior invasive malignancy (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 informed consent; 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 * Chronic obstructive pulmonary disease 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 human immunodeficiency virus (HIV) with CD4 count \< 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
Where it's running
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Saint Joseph's Hospital and Medical Center
Phoenix, Arizona, United States Recruiting -
Kaiser Permanente-Anaheim
Anaheim, California, United States Recruiting -
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn, California, United States Recruiting -
Kaiser Permanente-Bellflower
Bellflower, California, United States Recruiting -
Kaiser Permanente Dublin
Dublin, California, United States Recruiting -
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States Recruiting
Show 44 more locations
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Los Angeles General Medical Center
Los Angeles, California, United States Recruiting -
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States Recruiting -
Memorial Medical Center
Modesto, California, United States Recruiting -
Kaiser Permanente Oakland-Broadway
Oakland, California, United States Recruiting -
Kaiser Permanente-Ontario
Ontario, California, United States Recruiting -
Kaiser Permanente-Rancho Cordova Cancer Center
Rancho Cordova, California, United States Recruiting -
Rohnert Park Cancer Center
Rohnert Park, California, United States Recruiting -
Sutter Cancer Centers Radiation Oncology Services-Roseville
Roseville, California, United States Recruiting -
The Permanente Medical Group-Roseville Radiation Oncology
Roseville, California, United States Recruiting -
Sutter Medical Center Sacramento
Sacramento, California, United States Recruiting -
South Sacramento Cancer Center
Sacramento, California, United States Recruiting -
California Pacific Medical Center-Pacific Campus
San Francisco, California, United States Recruiting -
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, United States Recruiting -
Kaiser Permanente Cancer Treatment Center
South San Francisco, California, United States Recruiting -
Sutter Solano Medical Center/Cancer Center
Vallejo, California, United States Recruiting -
Hartford Hospital
Hartford, Connecticut, United States Recruiting -
Smilow Cancer Hospital Care Center-Trumbull
Trumbull, Connecticut, United States Recruiting -
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida, United States Recruiting -
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, United States Recruiting -
UM Sylvester Comprehensive Cancer Center at Doral
Doral, Florida, United States Recruiting -
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, Florida, United States Recruiting -
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States Recruiting -
AdventHealth Orlando
Orlando, Florida, United States Recruiting -
AdventHealth East Orlando
Orlando, Florida, United States Recruiting -
Memorial Hospital West
Pembroke Pines, Florida, United States Recruiting -
UM Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida, United States Recruiting -
Grady Health System
Atlanta, Georgia, United States Recruiting -
Emory Proton Therapy Center
Atlanta, Georgia, United States Recruiting -
Piedmont Hospital
Atlanta, Georgia, United States Recruiting -
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States Recruiting -
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States Recruiting -
Piedmont Fayette Hospital
Fayetteville, Georgia, United States Recruiting -
Piedmont Newnan Hospital
Newnan, Georgia, United States Recruiting -
Piedmont Henry Hospital
Stockbridge, Georgia, United States Recruiting -
Queen's Medical Center
Honolulu, Hawaii, United States Recruiting -
The Cancer Center of Hawaii-Liliha
Honolulu, Hawaii, United States Recruiting -
Northwestern University
Chicago, Illinois, United States Recruiting -
Rush MD Anderson Cancer Center
Chicago, Illinois, United States Recruiting -
University of Illinois
Chicago, Illinois, United States Recruiting -
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, United States Recruiting -
Loyola University Medical Center
Maywood, Illinois, United States Recruiting -
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, United States Recruiting -
Iowa Methodist Medical Center
Des Moines, Iowa, United States Recruiting -
The James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, United States Recruiting
+164 more sites. See ClinicalTrials.gov for the full list.
Study contacts
- Principal investigator: Michael A Vogelbaum — NRG Oncology
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.