AzTrials
AzTrials

Grade 2 MeningiomaPhase 3NCT03180268

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

A Phase 3 study testing Biospecimen Collection, Clinical Observation and Intensity-Modulated Radiation Therapy in people with Grade 2 Meningioma and Intracranial Meningioma, run by NRG Oncology at 215 sites in 5 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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 more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Grade 2 Meningioma, Intracranial Meningioma
What is being tested?
Biospecimen Collection, Clinical Observation and Intensity-Modulated Radiation Therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
162 participants
Where
215 sitesin 5 countries
Study dates
12 Sep 2017to 15 Jun 2032
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

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

215 sites in 5 countries.

215 sites in 5 countries

United States198 sites

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87106

  • American Fork Hospital / Huntsman Intermountain Cancer Center

    American Fork, Utah, 84003

  • Kaiser Permanente-Anaheim

    Anaheim, California, 92806

  • Trinity Health Saint Joseph Mercy Hospital Ann Arbor

    Ann Arbor, Michigan, 48106

  • University of Michigan Rogel Cancer Center

    Ann Arbor, Michigan, 48109

  • Langlade Hospital and Cancer Center

    Antigo, Wisconsin, 54409

  • Grady Health System

    Atlanta, Georgia, 30303

  • Emory Proton Therapy Center

    Atlanta, Georgia, 30308

  • Piedmont Hospital

    Atlanta, Georgia, 30309

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Emory Saint Joseph's Hospital

    Atlanta, Georgia, 30342

  • Northside Hospital

    Atlanta, Georgia, 30342

  • Sutter Cancer Centers Radiation Oncology Services-Auburn

    Auburn, California, 95603

  • Maryland Proton Treatment Center

    Baltimore, Maryland, 21201

  • University of Maryland/Greenebaum Cancer Center

    Baltimore, Maryland, 21201

  • Memorial Sloan Kettering Basking Ridge

    Basking Ridge, New Jersey, 07920

  • MaineHealth Coastal Cancer Treatment Center

    Bath, Maine, 04530

  • Kaiser Permanente-Bellflower

    Bellflower, California, 90706

  • Saint Luke's University Hospital-Bethlehem Campus

    Bethlehem, Pennsylvania, 18015

  • Billings Clinic Cancer Center

    Billings, Montana, 59101

  • University of Alabama at Birmingham Cancer Center

    Birmingham, Alabama, 35233

  • Boca Raton Regional Hospital

    Boca Raton, Florida, 33486

  • Prisma Health Cancer Institute - Spartanburg

    Boiling Springs, South Carolina, 29316

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • New York-Presbyterian/Brooklyn Methodist Hospital

    Brooklyn, New York, 11215

  • Christiana Care Health System-Concord Health Center

    Chadds Ford, Pennsylvania, 19317

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Chelsea Hospital

    Chelsea, Michigan, 48118

  • Northwestern University

    Chicago, Illinois, 60611

  • Rush MD Anderson Cancer Center

    Chicago, Illinois, 60612

  • University of Illinois

    Chicago, Illinois, 60612

  • Siteman Cancer Center at Saint Peters Hospital

    City of Saint Peters, Missouri, 63376

  • Case Western Reserve University

    Cleveland, Ohio, 44106

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Henry Ford Macomb Hospital-Clinton Township

    Clinton Township, Michigan, 48038

  • MU Health - University Hospital/Ellis Fischel Cancer Center

    Columbia, Missouri, 65212

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • Memorial Sloan Kettering Commack

    Commack, New York, 11725

  • UM Sylvester Comprehensive Cancer Center at Coral Gables

    Coral Gables, Florida, 33146

  • Siteman Cancer Center at West County Hospital

    Creve Coeur, Missouri, 63141

  • Northside Hospital-Forsyth

    Cumming, Georgia, 30041

  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas, Texas, 75390

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • UM Sylvester Comprehensive Cancer Center at Deerfield Beach

    Deerfield Beach, Florida, 33442

  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Henry Ford Health Saint John Hospital

    Detroit, Michigan, 48236

  • UM Sylvester Comprehensive Cancer Center at Doral

    Doral, Florida, 33166

  • Kaiser Permanente Dublin

    Dublin, California, 94568

  • Essentia Health Cancer Center

    Duluth, Minnesota, 55805

  • Miller-Dwan Hospital

    Duluth, Minnesota, 55805

  • Marshfield Medical Center-EC Cancer Center

    Eau Claire, Wisconsin, 54701

  • Mercy Cancer Center-Elyria

    Elyria, Ohio, 44035

  • Englewood Hospital and Medical Center

    Englewood, New Jersey, 07631

  • NorthShore University HealthSystem-Evanston Hospital

    Evanston, Illinois, 60201

  • Piedmont Fayette Hospital

    Fayetteville, Georgia, 30214

  • The New York Hospital Medical Center of Queens

    Flushing, New York, 11355

  • Northwestern Medicine Cancer Center Delnor

    Geneva, Illinois, 60134

  • NorthShore University HealthSystem-Glenbrook Hospital

    Glenview, Illinois, 60026

  • Trinity Health Grand Rapids Hospital

    Grand Rapids, Michigan, 49503

  • Benefis Sletten Cancer Institute

    Great Falls, Montana, 59405

  • Prisma Health Cancer Institute - Faris

    Greenville, South Carolina, 29605

  • Prisma Health Cancer Institute - Eastside

    Greenville, South Carolina, 29615

  • Prisma Health Cancer Institute - Greer

    Greer, South Carolina, 29650

  • Legacy Mount Hood Medical Center

    Gresham, Oregon, 97030

  • Memorial Sloan Kettering Westchester

    Harrison, New York, 10604

  • Hartford Hospital

    Hartford, Connecticut, 06102

  • NorthShore University HealthSystem-Highland Park Hospital

    Highland Park, Illinois, 60035

  • Memorial Regional Hospital/Joe DiMaggio Children's Hospital

    Hollywood, Florida, 33021

  • Queen's Medical Center

    Honolulu, Hawaii, 96813

  • The Cancer Center of Hawaii-Liliha

    Honolulu, Hawaii, 96817

  • UT MD Anderson Cancer Center

    Houston, Texas, 77030

  • Indiana University/Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

  • IU Health Methodist Hospital

    Indianapolis, Indiana, 46202

  • University of Iowa/Holden Comprehensive Cancer Center

    Iowa City, Iowa, 52242

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • Baptist MD Anderson Cancer Center

    Jacksonville, Florida, 32207

  • Logan Health Medical Center

    Kalispell, Montana, 59901

  • University of Kansas Cancer Center

    Kansas City, Kansas, 66160

  • Kettering Medical Center

    Kettering, Ohio, 45429

  • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

    Lebanon, New Hampshire, 03756

  • Geisinger Medical Oncology-Lewisburg

    Lewisburg, Pennsylvania, 17837

  • Lewistown Hospital

    Lewistown, Pennsylvania, 17044

  • University of Kentucky/Markey Cancer Center

    Lexington, Kentucky, 40536

  • Trinity Health Saint Mary Mercy Livonia Hospital

    Livonia, Michigan, 48154

  • Logan Regional Hospital

    Logan, Utah, 84321

  • Kaiser Permanente Los Angeles Medical Center

    Los Angeles, California, 90027

  • Los Angeles General Medical Center

    Los Angeles, California, 90033

  • USC / Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • The James Graham Brown Cancer Center at University of Louisville

    Louisville, Kentucky, 40202

  • UofL Health Medical Center Northeast

    Louisville, Kentucky, 40245

  • University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

    Madison, Wisconsin, 53718

  • University of Wisconsin Carbone Cancer Center - University Hospital

    Madison, Wisconsin, 53792

  • Marshfield Medical Center-Marshfield

    Marshfield, Wisconsin, 54449

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • Froedtert Menomonee Falls Hospital

    Menomonee Falls, Wisconsin, 53051

  • UH Seidman Cancer Center at Lake Health Mentor Campus

    Mentor, Ohio, 44060

  • University of Miami Miller School of Medicine-Sylvester Cancer Center

    Miami, Florida, 33136

  • Miami Cancer Institute

    Miami, Florida, 33176

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jersey, 07748

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Marshfield Medical Center - Minocqua

    Minocqua, Wisconsin, 54548

  • Memorial Medical Center

    Modesto, California, 95355

  • Memorial Sloan Kettering Bergen

    Montvale, New Jersey, 07645

  • Intermountain Medical Center

    Murray, Utah, 84107

  • Vanderbilt University/Ingram Cancer Center

    Nashville, Tennessee, 37232

  • Jersey Shore Medical Center

    Neptune City, New Jersey, 07753

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

  • Yale University

    New Haven, Connecticut, 06520

  • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

    New York, New York, 10032

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • NYP/Weill Cornell Medical Center

    New York, New York, 10065

  • Helen F Graham Cancer Center

    Newark, Delaware, 19713

  • Christiana Care Health System-Christiana Hospital

    Newark, Delaware, 19718

  • Rutgers New Jersey Medical School

    Newark, New Jersey, 07101

  • Piedmont Newnan Hospital

    Newnan, Georgia, 30265

  • Drexel Town Square Health Center

    Oak Creek, Wisconsin, 53154

  • Kaiser Permanente Oakland-Broadway

    Oakland, California, 94611

  • McKay-Dee Hospital Center

    Ogden, Utah, 84403

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • Kaiser Permanente-Ontario

    Ontario, California, 91761

  • UC Irvine Health/Chao Family Comprehensive Cancer Center

    Orange, California, 92868

  • AdventHealth Orlando

    Orlando, Florida, 32803

  • AdventHealth East Orlando

    Orlando, Florida, 32822

  • University of Kansas Cancer Center-Overland Park

    Overland Park, Kansas, 66210

  • Stanford Cancer Institute Palo Alto

    Palo Alto, California, 94304

  • Memorial Hospital West

    Pembroke Pines, Florida, 33028

  • Capital Health Medical Center-Hopewell

    Pennington, New Jersey, 08534

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140

  • Saint Joseph's Hospital and Medical Center

    Phoenix, Arizona, 85013

  • Mayo Clinic Hospital in Arizona

    Phoenix, Arizona, 85054

  • UM Sylvester Comprehensive Cancer Center at Plantation

    Plantation, Florida, 33324

  • MaineHealth Maine Medical Center - Portland

    Portland, Maine, 04102

  • Legacy Good Samaritan Hospital and Medical Center

    Portland, Oregon, 97210

  • Geisinger Cancer Services-Pottsville

    Pottsville, Pennsylvania, 17901

  • Utah Valley Regional Medical Center

    Provo, Utah, 84604

  • Kaiser Permanente-Rancho Cordova Cancer Center

    Rancho Cordova, California, 95670

  • Beebe Health Campus

    Rehoboth Beach, Delaware, 19971

  • Marshfield Medical Center-Rice Lake

    Rice Lake, Wisconsin, 54868

  • VCU Massey Comprehensive Cancer Center

    Richmond, Virginia, 23298

  • Riverton Hospital

    Riverton, Utah, 84065

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

  • University of Rochester

    Rochester, New York, 14642

  • Rohnert Park Cancer Center

    Rohnert Park, California, 94928

  • Sutter Cancer Centers Radiation Oncology Services-Roseville

    Roseville, California, 95661

  • The Permanente Medical Group-Roseville Radiation Oncology

    Roseville, California, 95678

  • Sutter Medical Center Sacramento

    Sacramento, California, 95816

  • South Sacramento Cancer Center

    Sacramento, California, 95823

  • MyMichigan Medical Center Saginaw

    Saginaw, Michigan, 48601

  • Dartmouth Cancer Center - North

    Saint Johnsbury, Vermont, 05819

  • Park Nicollet Clinic - Saint Louis Park

    Saint Louis Park, Minnesota, 55416

  • Regions Hospital

    Saint Paul, Minnesota, 55101

  • LDS Hospital

    Salt Lake City, Utah, 84143

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229

  • California Pacific Medical Center-Pacific Campus

    San Francisco, California, 94115

  • MaineHealth Cancer Care Center of York County

    Sanford, Maine, 04073

  • Kaiser Permanente Medical Center - Santa Clara

    Santa Clara, California, 95051

  • MaineHealth Maine Medical Center- Scarborough

    Scarborough, Maine, 04074

  • Mayo Clinic in Arizona

    Scottsdale, Arizona, 85259

  • TidalHealth Nanticoke / Allen Cancer Center

    Seaford, Delaware, 19973

  • University of Washington Medical Center - Montlake

    Seattle, Washington, 98195

  • Prisma Health Cancer Institute - Seneca

    Seneca, South Carolina, 29672

  • LSU Health Sciences Center at Shreveport

    Shreveport, Louisiana, 71103

  • ProCure Proton Therapy Center-Somerset

    Somerset, New Jersey, 08873

  • Robert Wood Johnson University Hospital Somerset

    Somerville, New Jersey, 08876

  • Kaiser Permanente Cancer Treatment Center

    South San Francisco, California, 94080

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Siteman Cancer Center-South County

    St Louis, Missouri, 63129

  • Aspirus Cancer Care - Stevens Point

    Stevens Point, Wisconsin, 54481

  • Marshfield Medical Center-River Region at Stevens Point

    Stevens Point, Wisconsin, 54482

  • Piedmont Henry Hospital

    Stockbridge, Georgia, 30281

  • ProMedica Flower Hospital

    Sylvania, Ohio, 43560

  • Moffitt Cancer Center

    Tampa, Florida, 33612

  • Smilow Cancer Hospital Care Center-Trumbull

    Trumbull, Connecticut, 06611

  • University of Arizona Cancer Center-Orange Grove Campus

    Tucson, Arizona, 85704

  • Banner University Medical Center - Tucson

    Tucson, Arizona, 85719

  • University of Arizona Cancer Center-North Campus

    Tucson, Arizona, 85719

  • Memorial Sloan Kettering Nassau

    Uniondale, New York, 11553

  • Westchester Medical Center

    Valhalla, New York, 10595

  • Sutter Solano Medical Center/Cancer Center

    Vallejo, California, 94589

  • Legacy Salmon Creek Hospital

    Vancouver, Washington, 98686

  • Henry Ford Health Warren Hospital

    Warren, Michigan, 48093

  • Northwestern Medicine Cancer Center Warrenville

    Warrenville, Illinois, 60555

  • UW Cancer Center at ProHealth Care

    Waukesha, Wisconsin, 53188

  • Aspirus Regional Cancer Center

    Wausau, Wisconsin, 54401

  • Henry Ford West Bloomfield Hospital

    West Bloomfield, Michigan, 48322

  • UHHS-Westlake Medical Center

    Westlake, Ohio, 44145

  • Marshfield Medical Center - Weston

    Weston, Wisconsin, 54476

  • Geisinger Wyoming Valley/Henry Cancer Center

    Wilkes-Barre, Pennsylvania, 18711

  • Aspirus Cancer Care - Wisconsin Rapids

    Wisconsin Rapids, Wisconsin, 54494

  • Lankenau Medical Center

    Wynnewood, Pennsylvania, 19096

  • University of Michigan Health - West

    Wyoming, Michigan, 49519

Other trials in United States

Canada8 sites

  • Arthur J E Child Comprehensive Cancer Centre

    Calgary, Alberta, T2N 5G2

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • Juravinski Cancer Centre at Hamilton Health Sciences

    Hamilton, Ontario, L8V 5C2

  • London Regional Cancer Program

    London, Ontario, N6A 4L6

  • CHUM - Centre Hospitalier de l'Universite de Montreal

    Montreal, Quebec, H2X 3E4

  • The Research Institute of the McGill University Health Centre (MUHC)

    Montreal, Quebec, H3H 2R9

  • Allan Blair Cancer Centre

    Regina, Saskatchewan, S4T 7T1

  • University Health Network-Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Japan7 sites

  • Hiroshima University Hospital

    Hiroshima, 734-8551

  • Kyorin University Hospital

    Mitaka-shi, Tokyo, 181-8611

  • Saitama Medical University International Medical Center

    Saitama, 350-1298

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8648

  • Keio University

    Shinjuku-ku, Tokyo, 160-8582

  • Iwate Medical University Hospital

    Shiwa-gun, Iwate, 028-3695

  • National Cancer Center Hospital

    Tokyo, 104 0045

Other trials in Japan

India1 site

  • Tata Memorial Hospital

    Mumbai, 400 012

Other trials in India

Saudi Arabia1 site

  • King Faisal Specialist Hospital and Research Centre

    Riyadh, 11211

Other trials in Saudi Arabia

About this study

Official title: 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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. 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:

  1. 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.

Being tested
Biospecimen Collection, Clinical Observation, Intensity-Modulated Radiation Therapy, Laboratory Biomarker Analysis, Magnetic Resonance Imaging
Medical subject headings
Meningioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo collection of blood samples

  • Clinical ObservationOther

    Also called observation

    Undergo observation

  • Intensity-Modulated Radiation TherapyRadiation

    Also called IMRT, Intensity modulated radiation therapy (procedure), Intensity Modulated RT, Intensity-Modulated Radiotherapy

    Undergo IMRT

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan

    Undergo MRI

  • Proton Beam Radiation TherapyRadiation

    Also called External beam radiation therapy protons (procedure), External Beam Radiotherapy (protons), PBRT, Proton

    Undergo proton beam radiation therapy

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

Study groups in NCT03180268
Study groupRoleWhat they receive
Arm I (observation)Active comparatorPatients undergo observation. Additionally, patients undergo MRI and blood collection throughout the study.
Receives: Procedure: Biospecimen Collection; Other: Clinical Observation; Other: Laboratory Biomarker Analysis; Procedure: Magnetic Resonance Imaging; Other: Quality-of-Life Assessment
Arm II (radiation therapy)ExperimentalPatients 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.
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (14)

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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).

    Measured: Up to 3 years

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

    Measured: Up to 10 years

  10. Concordance rate of central versus parent-institution pathology

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: Baseline up to 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2017
  2. Study start12 Sep 2017
  3. Primary completion15 Jun 2027 (estimated)
  4. Study completion15 Jun 2032 (estimated)

Resources

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
162 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03180268
Sponsor's protocol ID
NRG-BN003
Other IDs
NCI-2016-01619, NRG-BN003, NRG-BN003, NRG-BN003, U10CA180868
Status last verified
Sep 2026
First submitted
6 Jun 2017
Last updated
2 Oct 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Biospecimen Collection, Clinical Observation and Intensity-Modulated Radiation Therapy in people with Grade 2 Meningioma and Intracranial Meningioma, run by NRG Oncology at 215 sites in 5 countries.

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 13 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 215 sites in United States, Canada, Japan, India, Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.

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 (PFS) (time frame: From randomization to the first documented disease progression, or death due to any cause, whichever comes first, assessed up to 10 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03180268.

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 2 Oct 2026.

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