Observation or Radiation Therapy in Treating Patients With Newly Diagnosed Grade II Meningioma That Has Been Completely Removed by Surgery
Key facts
- Where
- Albuquerque, American Fork, Anaheim, Ann Arbor, Antigo, Atlanta, Auburn, Baltimore, Basking Ridge, Bath, Bellflower, Bethlehem, Billings, Birmingham, Boca Raton, Boiling Springs, Boston, Brooklyn, Chadds Ford, Chapel Hill, Charleston, Chelsea, Chicago, City of Saint Peters, Cleveland, Clinton Township, Columbia, Columbus, Commack, Coral Gables, Creve Coeur, Cumming, Dallas, Danville, Decatur, Deerfield Beach, Des Moines, Detroit, Doral, Dublin, Duluth, Eau Claire, Elyria, Englewood, Evanston, Fayetteville, Flushing, Geneva, Glenview, Grand Rapids, Great Falls, Greenville, Greer, Gresham, Harrison, Hartford, Highland Park, Hollywood, Honolulu, Houston, Indianapolis, Iowa City, Jackson, Jacksonville, Kalispell, Kansas City, Kettering, Lebanon, Lewisburg, Lewistown, Lexington, Livonia, Logan, Los Angeles, Louisville, Madison, Marshfield, Maywood, Menomonee Falls, Mentor, Miami, Middletown, Milwaukee, Minneapolis, Minocqua, Modesto, Montvale, Murray, Nashville, Neptune City, New Brunswick, New Haven, New York, Newark, Newnan, Oak Creek, Oakland, Ogden, Oklahoma City, Omaha, Ontario, Orange, Orlando, Overland Park, Palo Alto, Pembroke Pines, Pennington, Philadelphia, Phoenix, Plantation, Portland, Pottsville, Provo, Rancho Cordova, Rehoboth Beach, Rice Lake, Richmond, Riverton, Rochester, Rohnert Park, Roseville, Sacramento, Saginaw, Saint Johnsbury, Saint Louis Park, Saint Paul, Salt Lake City, San Antonio, San Francisco, Sanford, Santa Clara, Scarborough, Scottsdale, Seaford, Seattle, Seneca, Shreveport, Somerset, Somerville, South San Francisco, St Louis, Stevens Point, Stockbridge, Sylvania, Tampa, Trumbull, Tucson, Uniondale, Valhalla, Vallejo, Vancouver, Warren, Warrenville, Waukesha, Wausau, West Bloomfield, Westlake, Weston, Wilkes-Barre, Wisconsin Rapids, Wynnewood, and Wyoming, United StatesSee the 198 sites
- Phase
- Phase 3
Where in United States
- University of New Mexico Cancer CenterAlbuquerque, United StatesNo longer taking part
- American Fork Hospital / Huntsman Intermountain Cancer CenterAmerican Fork, United StatesNo longer taking part
- Kaiser Permanente-AnaheimAnaheim, United StatesNo longer taking part
- Trinity Health Saint Joseph Mercy Hospital Ann ArborAnn Arbor, United StatesNo longer taking part
- University of Michigan Rogel Cancer CenterAnn Arbor, United StatesNo longer taking part
- Langlade Hospital and Cancer CenterAntigo, United StatesNo longer taking part
- Emory Proton Therapy CenterAtlanta, United StatesNo longer taking part
- Emory Saint Joseph's HospitalAtlanta, United StatesNo longer taking part
- Emory University Hospital/Winship Cancer InstituteAtlanta, United StatesNo longer taking part
- Grady Health SystemAtlanta, United StatesNo longer taking part
- Northside HospitalAtlanta, United StatesNo longer taking part
- Piedmont HospitalAtlanta, United StatesNo longer taking part
- Sutter Cancer Centers Radiation Oncology Services-AuburnAuburn, United StatesNo longer taking part
- Maryland Proton Treatment CenterBaltimore, United StatesNo longer taking part
- University of Maryland/Greenebaum Cancer CenterBaltimore, United StatesNo longer taking part
- Memorial Sloan Kettering Basking RidgeBasking Ridge, United StatesNo longer taking part
- MaineHealth Coastal Cancer Treatment CenterBath, United StatesNo longer taking part
- Kaiser Permanente-BellflowerBellflower, United StatesNo longer taking part
- Saint Luke's University Hospital-Bethlehem CampusBethlehem, United StatesNo longer taking part
- Billings Clinic Cancer CenterBillings, United StatesNo longer taking part
- University of Alabama at Birmingham Cancer CenterBirmingham, United StatesNo longer taking part
- Boca Raton Regional HospitalBoca Raton, United StatesNo longer taking part
- Prisma Health Cancer Institute - SpartanburgBoiling Springs, United StatesNo longer taking part
- Tufts Medical CenterBoston, United StatesNo longer taking part
- New York-Presbyterian/Brooklyn Methodist HospitalBrooklyn, United StatesNo longer taking part
- Christiana Care Health System-Concord Health CenterChadds Ford, United StatesNo longer taking part
- UNC Lineberger Comprehensive Cancer CenterChapel Hill, United StatesNo longer taking part
- Medical University of South CarolinaCharleston, United StatesNo longer taking part
- Chelsea HospitalChelsea, United StatesNo longer taking part
- Northwestern UniversityChicago, United StatesNo longer taking part
- Rush MD Anderson Cancer CenterChicago, United StatesNo longer taking part
- University of IllinoisChicago, United StatesNo longer taking part
- Siteman Cancer Center at Saint Peters HospitalCity of Saint Peters, United StatesNo longer taking part
- Case Western Reserve UniversityCleveland, United StatesNo longer taking part
- Cleveland Clinic FoundationCleveland, United StatesNo longer taking part
- Henry Ford Macomb Hospital-Clinton TownshipClinton Township, United StatesNo longer taking part
- MU Health - University Hospital/Ellis Fischel Cancer CenterColumbia, United StatesNo longer taking part
- Ohio State University Comprehensive Cancer CenterColumbus, United StatesNo longer taking part
- Memorial Sloan Kettering CommackCommack, United StatesNo longer taking part
- UM Sylvester Comprehensive Cancer Center at Coral GablesCoral Gables, United StatesNo longer taking part
- Siteman Cancer Center at West County HospitalCreve Coeur, United StatesNo longer taking part
- Northside Hospital-ForsythCumming, United StatesNo longer taking part
- UT Southwestern/Simmons Cancer Center-DallasDallas, United StatesNo longer taking part
- Geisinger Medical CenterDanville, United StatesNo longer taking part
- Decatur Memorial HospitalDecatur, United StatesNo longer taking part
- UM Sylvester Comprehensive Cancer Center at Deerfield BeachDeerfield Beach, United StatesNo longer taking part
- Iowa Methodist Medical CenterDes Moines, United StatesNo longer taking part
- Henry Ford Health Saint John HospitalDetroit, United StatesNo longer taking part
- Henry Ford HospitalDetroit, United StatesNo longer taking part
- UM Sylvester Comprehensive Cancer Center at DoralDoral, United StatesNo longer taking part
- Kaiser Permanente DublinDublin, United StatesNo longer taking part
- Essentia Health Cancer CenterDuluth, United StatesNo longer taking part
- Miller-Dwan HospitalDuluth, United StatesNo longer taking part
- Marshfield Medical Center-EC Cancer CenterEau Claire, United StatesNo longer taking part
- Mercy Cancer Center-ElyriaElyria, United StatesNo longer taking part
- Englewood Hospital and Medical CenterEnglewood, United StatesNo longer taking part
- NorthShore University HealthSystem-Evanston HospitalEvanston, United StatesNo longer taking part
- Piedmont Fayette HospitalFayetteville, United StatesNo longer taking part
- The New York Hospital Medical Center of QueensFlushing, United StatesNo longer taking part
- Northwestern Medicine Cancer Center DelnorGeneva, United StatesNo longer taking part
- NorthShore University HealthSystem-Glenbrook HospitalGlenview, United StatesNo longer taking part
- Trinity Health Grand Rapids HospitalGrand Rapids, United StatesNo longer taking part
- Benefis Sletten Cancer InstituteGreat Falls, United StatesNo longer taking part
- Prisma Health Cancer Institute - EastsideGreenville, United StatesNo longer taking part
- Prisma Health Cancer Institute - FarisGreenville, United StatesNo longer taking part
- Prisma Health Cancer Institute - GreerGreer, United StatesNo longer taking part
- Legacy Mount Hood Medical CenterGresham, United StatesNo longer taking part
- Memorial Sloan Kettering WestchesterHarrison, United StatesNo longer taking part
- Hartford HospitalHartford, United StatesNo longer taking part
- NorthShore University HealthSystem-Highland Park HospitalHighland Park, United StatesNo longer taking part
- Memorial Regional Hospital/Joe DiMaggio Children's HospitalHollywood, United StatesNo longer taking part
- Queen's Medical CenterHonolulu, United StatesNo longer taking part
- The Cancer Center of Hawaii-LilihaHonolulu, United StatesNo longer taking part
- UT MD Anderson Cancer CenterHouston, United StatesNo longer taking part
- Indiana University/Melvin and Bren Simon Cancer CenterIndianapolis, United StatesNo longer taking part
- IU Health Methodist HospitalIndianapolis, United StatesNo longer taking part
- University of Iowa/Holden Comprehensive Cancer CenterIowa City, United StatesNo longer taking part
- University of Mississippi Medical CenterJackson, United StatesNo longer taking part
- Baptist MD Anderson Cancer CenterJacksonville, United StatesNo longer taking part
- Logan Health Medical CenterKalispell, United StatesNo longer taking part
- University of Kansas Cancer CenterKansas City, United StatesNo longer taking part
- Kettering Medical CenterKettering, United StatesNo longer taking part
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer CenterLebanon, United StatesNo longer taking part
- Geisinger Medical Oncology-LewisburgLewisburg, United StatesNo longer taking part
- Lewistown HospitalLewistown, United StatesNo longer taking part
- University of Kentucky/Markey Cancer CenterLexington, United StatesNo longer taking part
- Trinity Health Saint Mary Mercy Livonia HospitalLivonia, United StatesNo longer taking part
- Logan Regional HospitalLogan, United StatesNo longer taking part
- Kaiser Permanente Los Angeles Medical CenterLos Angeles, United StatesNo longer taking part
- Los Angeles General Medical CenterLos Angeles, United StatesNo longer taking part
- USC / Norris Comprehensive Cancer CenterLos Angeles, United StatesNo longer taking part
- The James Graham Brown Cancer Center at University of LouisvilleLouisville, United StatesNo longer taking part
- UofL Health Medical Center NortheastLouisville, United StatesNo longer taking part
- University of Wisconsin Carbone Cancer Center - Eastpark Medical CenterMadison, United StatesNo longer taking part
- University of Wisconsin Carbone Cancer Center - University HospitalMadison, United StatesNo longer taking part
- Marshfield Medical Center-MarshfieldMarshfield, United StatesNo longer taking part
- Loyola University Medical CenterMaywood, United StatesNo longer taking part
- Froedtert Menomonee Falls HospitalMenomonee Falls, United StatesNo longer taking part
- UH Seidman Cancer Center at Lake Health Mentor CampusMentor, United StatesNo longer taking part
- Miami Cancer InstituteMiami, United StatesNo longer taking part
- University of Miami Miller School of Medicine-Sylvester Cancer CenterMiami, United StatesNo longer taking part
- Memorial Sloan Kettering MonmouthMiddletown, United StatesNo longer taking part
- Medical College of WisconsinMilwaukee, United StatesNo longer taking part
- Abbott-Northwestern HospitalMinneapolis, United StatesNo longer taking part
- Marshfield Medical Center - MinocquaMinocqua, United StatesNo longer taking part
- Memorial Medical CenterModesto, United StatesNo longer taking part
- Memorial Sloan Kettering BergenMontvale, United StatesNo longer taking part
- Intermountain Medical CenterMurray, United StatesNo longer taking part
- Vanderbilt University/Ingram Cancer CenterNashville, United StatesNo longer taking part
- Jersey Shore Medical CenterNeptune City, United StatesNo longer taking part
- Rutgers Cancer Institute of New JerseyNew Brunswick, United StatesNo longer taking part
- Yale UniversityNew Haven, United StatesNo longer taking part
- Memorial Sloan-Kettering Cancer CenterNew York, United StatesNo longer taking part
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer CenterNew York, United StatesNo longer taking part
- NYP/Weill Cornell Medical CenterNew York, United StatesNo longer taking part
- Christiana Care Health System-Christiana HospitalNewark, United StatesNo longer taking part
- Helen F Graham Cancer CenterNewark, United StatesNo longer taking part
- Rutgers New Jersey Medical SchoolNewark, United StatesNo longer taking part
- Piedmont Newnan HospitalNewnan, United StatesNo longer taking part
- Drexel Town Square Health CenterOak Creek, United StatesNo longer taking part
- Kaiser Permanente Oakland-BroadwayOakland, United StatesNo longer taking part
- McKay-Dee Hospital CenterOgden, United StatesNo longer taking part
- University of Oklahoma Health Sciences CenterOklahoma City, United StatesNo longer taking part
- University of Nebraska Medical CenterOmaha, United StatesNo longer taking part
- Kaiser Permanente-OntarioOntario, United StatesNo longer taking part
- UC Irvine Health- Chao Family Comprehensive Cancer CenterOrange, United StatesNo longer taking part
- AdventHealth East OrlandoOrlando, United StatesNo longer taking part
- AdventHealth OrlandoOrlando, United StatesNo longer taking part
- University of Kansas Cancer Center-Overland ParkOverland Park, United StatesNo longer taking part
- Stanford Cancer Institute Palo AltoPalo Alto, United StatesNo longer taking part
- Memorial Hospital WestPembroke Pines, United StatesNo longer taking part
- Capital Health Medical Center-HopewellPennington, United StatesNo longer taking part
- Fox Chase Cancer CenterPhiladelphia, United StatesNo longer taking part
- Temple University HospitalPhiladelphia, United StatesNo longer taking part
- Thomas Jefferson University HospitalPhiladelphia, United StatesNo longer taking part
- Mayo Clinic Hospital in ArizonaPhoenix, United StatesNo longer taking part
- Saint Joseph's Hospital and Medical CenterPhoenix, United StatesNo longer taking part
- UM Sylvester Comprehensive Cancer Center at PlantationPlantation, United StatesNo longer taking part
- Legacy Good Samaritan Hospital and Medical CenterPortland, United StatesNo longer taking part
- MaineHealth Maine Medical Center - PortlandPortland, United StatesNo longer taking part
- Geisinger Cancer Services-PottsvillePottsville, United StatesNo longer taking part
- Utah Valley Regional Medical CenterProvo, United StatesNo longer taking part
- Kaiser Permanente-Rancho Cordova Cancer CenterRancho Cordova, United StatesNo longer taking part
- Beebe Health CampusRehoboth Beach, United StatesNo longer taking part
- Marshfield Medical Center-Rice LakeRice Lake, United StatesNo longer taking part
- VCU Massey Comprehensive Cancer CenterRichmond, United StatesNo longer taking part
- Riverton HospitalRiverton, United StatesNo longer taking part
- Mayo Clinic in RochesterRochester, United StatesNo longer taking part
- University of RochesterRochester, United StatesNo longer taking part
- Rohnert Park Cancer CenterRohnert Park, United StatesNo longer taking part
- Sutter Cancer Centers Radiation Oncology Services-RosevilleRoseville, United StatesNo longer taking part
- The Permanente Medical Group-Roseville Radiation OncologyRoseville, United StatesNo longer taking part
- South Sacramento Cancer CenterSacramento, United StatesNo longer taking part
- Sutter Medical Center SacramentoSacramento, United StatesNo longer taking part
- MyMichigan Medical Center SaginawSaginaw, United StatesNo longer taking part
- Dartmouth Cancer Center - NorthSaint Johnsbury, United StatesNo longer taking part
- Park Nicollet Clinic - Saint Louis ParkSaint Louis Park, United StatesNo longer taking part
- Regions HospitalSaint Paul, United StatesNo longer taking part
- LDS HospitalSalt Lake City, United StatesNo longer taking part
- University of Texas Health Science Center at San AntonioSan Antonio, United StatesNo longer taking part
- California Pacific Medical Center-Pacific CampusSan Francisco, United StatesNo longer taking part
- MaineHealth Cancer Care Center of York CountySanford, United StatesNo longer taking part
- Kaiser Permanente Medical Center - Santa ClaraSanta Clara, United StatesNo longer taking part
- MaineHealth Maine Medical Center- ScarboroughScarborough, United StatesNo longer taking part
- Mayo Clinic in ArizonaScottsdale, United StatesNo longer taking part
- TidalHealth Nanticoke / Allen Cancer CenterSeaford, United StatesNo longer taking part
- University of Washington Medical Center - MontlakeSeattle, United StatesNo longer taking part
- Prisma Health Cancer Institute - SenecaSeneca, United StatesNo longer taking part
- LSU Health Sciences Center at ShreveportShreveport, United StatesNo longer taking part
- ProCure Proton Therapy Center-SomersetSomerset, United StatesNo longer taking part
- Robert Wood Johnson University Hospital SomersetSomerville, United StatesNo longer taking part
- Kaiser Permanente Cancer Treatment CenterSouth San Francisco, United StatesNo longer taking part
- Siteman Cancer Center-South CountySt Louis, United StatesNo longer taking part
- Washington University School of MedicineSt Louis, United StatesNo longer taking part
- Aspirus Cancer Care - Stevens PointStevens Point, United StatesNo longer taking part
- Marshfield Medical Center-River Region at Stevens PointStevens Point, United StatesNo longer taking part
- Piedmont Henry HospitalStockbridge, United StatesNo longer taking part
- ProMedica Flower HospitalSylvania, United StatesNo longer taking part
- Moffitt Cancer CenterTampa, United StatesNo longer taking part
- Smilow Cancer Hospital Care Center-TrumbullTrumbull, United StatesNo longer taking part
- Banner University Medical Center - TucsonTucson, United StatesNo longer taking part
- University of Arizona Cancer Center-North CampusTucson, United StatesNo longer taking part
- University of Arizona Cancer Center-Orange Grove CampusTucson, United StatesNo longer taking part
- Memorial Sloan Kettering NassauUniondale, United StatesNo longer taking part
- Westchester Medical CenterValhalla, United StatesNo longer taking part
- Sutter Solano Medical Center/Cancer CenterVallejo, United StatesNo longer taking part
- Legacy Salmon Creek HospitalVancouver, United StatesNo longer taking part
- Henry Ford Health Warren HospitalWarren, United StatesNo longer taking part
- Northwestern Medicine Cancer Center WarrenvilleWarrenville, United StatesNo longer taking part
- UW Cancer Center at ProHealth CareWaukesha, United StatesNo longer taking part
- Aspirus Regional Cancer CenterWausau, United StatesNo longer taking part
- Henry Ford West Bloomfield HospitalWest Bloomfield, United StatesNo longer taking part
- UHHS-Westlake Medical CenterWestlake, United StatesNo longer taking part
- Marshfield Medical Center - WestonWeston, United StatesNo longer taking part
- Geisinger Wyoming Valley/Henry Cancer CenterWilkes-Barre, United StatesNo longer taking part
- Aspirus Cancer Care - Wisconsin RapidsWisconsin Rapids, United StatesNo longer taking part
- Lankenau Medical CenterWynnewood, United StatesNo longer taking part
- University of Michigan Health - WestWyoming, United StatesNo longer taking part
Trial details
- Who runs it
- NRG Oncology
- Trial code
- NCT03180268
- Record updated
- 2 October 2026
- Original description
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 full original descriptionShow less
Phase III Trial of Observation Versus Irradiation for a Gross Totally Resected Grade II Meningioma
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.
Inclusion: 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: Previous radiotherapy to the scalp, cranium, brain, or skull base and radiation-induced meningiomas; 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); 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; 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).