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

May 5, 2026 updated by: NRG Oncology

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

163

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 5G2
        • Suspended
        • Arthur J E Child Comprehensive Cancer Centre
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Active, not recruiting
        • Cross Cancer Institute
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Suspended
        • Juravinski Cancer Centre at Hamilton Health Sciences
      • London, Ontario, Canada, N6A 4L6
        • Suspended
        • London Regional Cancer Program
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • University Health Network-Princess Margaret Hospital
        • Contact:
        • Principal Investigator:
          • Derek S. Tsang
    • Quebec
      • Montreal, Quebec, Canada, H3H 2R9
        • Recruiting
        • The Research Institute of the McGill University Health Centre (MUHC)
        • Contact:
        • Principal Investigator:
          • Bassam S. Abdulkarim
      • Montreal, Quebec, Canada, H2X 3E4
        • Suspended
        • CHUM - Centre Hospitalier de l'Universite de Montreal
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4T 7T1
        • Active, not recruiting
        • Allan Blair Cancer Centre
  • India
      • Mumbai, India, 400 012
        • Suspended
        • Tata Memorial Hospital
  • Japan
      • Hiroshima, Japan, 734-8551
        • Recruiting
        • Hiroshima University Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 82-424-6042
        • Principal Investigator:
          • Fumiyuki Yamasaki
      • Saitama, Japan, 350-1298
        • Recruiting
        • Saitama Medical University International Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 81-49-276-2028
        • Principal Investigator:
          • Mitsuaki Shirahata
      • Tokyo, Japan, 104 0045
        • Recruiting
        • National Cancer Center Hospital
        • Contact:
        • Principal Investigator:
          • Yoshitaka Narita
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8648
        • Recruiting
        • Hokkaido University Hospital
        • Contact:
        • Principal Investigator:
          • Shigeru Yamaguchi
    • Iwate
      • Shiwa-gun, Iwate, Japan, 028-3695
        • Recruiting
        • Iwate Medical University Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 81-19-613-7111
        • Principal Investigator:
          • Takaaki Beppu
    • Tokyo
      • Mitaka-shi, Tokyo, Japan, 181-8611
        • Recruiting
        • Kyorin University Hospital
        • Contact:
        • Principal Investigator:
          • Motoo Nagane
      • Shinjuku-ku, Tokyo, Japan, 160-8582
        • Recruiting
        • Keio University
        • Contact:
          • Site Public Contact
          • Phone Number: 03 5363-3848
        • Principal Investigator:
          • Masahiro Toda
  • Saudi Arabia
      • Riyadh, Saudi Arabia, 11211
        • Suspended
        • King Faisal Specialist Hospital and Research Centre
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Active, not recruiting
        • University of Alabama at Birmingham Cancer Center
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Active, not recruiting
        • Mayo Clinic Hospital in Arizona
      • Phoenix, Arizona, United States, 85013
        • Recruiting
        • Saint Joseph's Hospital and Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 877-602-4111
        • Principal Investigator:
          • Igor J. Barani
      • Scottsdale, Arizona, United States, 85259
        • Active, not recruiting
        • Mayo Clinic in Arizona
      • Tucson, Arizona, United States, 85704
        • Suspended
        • University of Arizona Cancer Center-Orange Grove Campus
      • Tucson, Arizona, United States, 85719
        • Suspended
        • Banner University Medical Center - Tucson
      • Tucson, Arizona, United States, 85719
        • Suspended
        • University of Arizona Cancer Center-North Campus
    • California
      • Anaheim, California, United States, 92806
        • Recruiting
        • Kaiser Permanente-Anaheim
        • Contact:
        • Principal Investigator:
          • Aakash Batra
      • Auburn, California, United States, 95603
        • Recruiting
        • Sutter Cancer Centers Radiation Oncology Services-Auburn
        • Principal Investigator:
          • Christopher U. Jones
        • Contact:
      • Bellflower, California, United States, 90706
        • Recruiting
        • Kaiser Permanente-Bellflower
        • Contact:
        • Principal Investigator:
          • Aakash Batra
      • Dublin, California, United States, 94568
        • Recruiting
        • Kaiser Permanente Dublin
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
        • Principal Investigator:
          • Samantha A. Seaward
      • Los Angeles, California, United States, 90027
        • Recruiting
        • Kaiser Permanente Los Angeles Medical Center
        • Contact:
        • Principal Investigator:
          • Aakash Batra
      • Los Angeles, California, United States, 90033
        • Recruiting
        • USC / Norris Comprehensive Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 323-865-0451
        • Principal Investigator:
          • Eric L. Chang
      • Los Angeles, California, United States, 90033
        • Recruiting
        • Los Angeles General Medical Center
        • Principal Investigator:
          • Eric L. Chang
        • Contact:
      • Modesto, California, United States, 95355
      • Oakland, California, United States, 94611
        • Recruiting
        • Kaiser Permanente Oakland-Broadway
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Samantha A. Seaward
      • Ontario, California, United States, 91761
        • Recruiting
        • Kaiser Permanente-Ontario
        • Contact:
        • Principal Investigator:
          • Aakash Batra
      • Orange, California, United States, 92868
        • Active, not recruiting
        • UC Irvine Health/Chao Family Comprehensive Cancer Center
      • Palo Alto, California, United States, 94304
        • Active, not recruiting
        • Stanford Cancer Institute Palo Alto
      • Rancho Cordova, California, United States, 95670
        • Recruiting
        • Kaiser Permanente-Rancho Cordova Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Samantha A. Seaward
      • Rohnert Park, California, United States, 94928
        • Recruiting
        • Rohnert Park Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Samantha A. Seaward
      • Roseville, California, United States, 95661
        • Recruiting
        • Sutter Cancer Centers Radiation Oncology Services-Roseville
        • Principal Investigator:
          • Christopher U. Jones
        • Contact:
      • Roseville, California, United States, 95678
        • Recruiting
        • The Permanente Medical Group-Roseville Radiation Oncology
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Samantha A. Seaward
      • Sacramento, California, United States, 95816
      • Sacramento, California, United States, 95823
        • Recruiting
        • South Sacramento Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Samantha A. Seaward
      • San Francisco, California, United States, 94115
        • Recruiting
        • California Pacific Medical Center-Pacific Campus
        • Principal Investigator:
          • Christopher U. Jones
        • Contact:
      • Santa Clara, California, United States, 95051
        • Recruiting
        • Kaiser Permanente Medical Center - Santa Clara
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Samantha A. Seaward
      • South San Francisco, California, United States, 94080
        • Recruiting
        • Kaiser Permanente Cancer Treatment Center
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Samantha A. Seaward
      • Vallejo, California, United States, 94589
        • Recruiting
        • Sutter Solano Medical Center/Cancer Center
        • Principal Investigator:
          • Christopher U. Jones
        • Contact:
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Recruiting
        • Hartford Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 860-545-5363
        • Principal Investigator:
          • Alexis M. Demopoulos
      • New Haven, Connecticut, United States, 06520
        • Active, not recruiting
        • Yale University
      • Trumbull, Connecticut, United States, 06611
        • Recruiting
        • Smilow Cancer Hospital Care Center-Trumbull
        • Contact:
        • Principal Investigator:
          • Nicholas A. Blondin
    • Delaware
      • Newark, Delaware, United States, 19713
        • Active, not recruiting
        • Helen F Graham Cancer Center
      • Newark, Delaware, United States, 19718
        • Active, not recruiting
        • Christiana Care Health System-Christiana Hospital
      • Rehoboth Beach, Delaware, United States, 19971
        • Active, not recruiting
        • Beebe Health Campus
      • Seaford, Delaware, United States, 19973
        • Active, not recruiting
        • TidalHealth Nanticoke / Allen Cancer Center
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Active, not recruiting
        • Boca Raton Regional Hospital
      • Coral Gables, Florida, United States, 33146
        • Recruiting
        • UM Sylvester Comprehensive Cancer Center at Coral Gables
        • Contact:
          • Site Public Contact
          • Phone Number: 305-243-2647
        • Principal Investigator:
          • Gregory J. Kubicek
      • Deerfield Beach, Florida, United States, 33442
        • Recruiting
        • UM Sylvester Comprehensive Cancer Center at Deerfield Beach
        • Contact:
          • Site Public Contact
          • Phone Number: 305-243-2647
        • Principal Investigator:
          • Gregory J. Kubicek
      • Doral, Florida, United States, 33166
        • Recruiting
        • UM Sylvester Comprehensive Cancer Center at Doral
        • Principal Investigator:
          • Gregory J. Kubicek
        • Contact:
      • Hollywood, Florida, United States, 33021
        • Recruiting
        • Memorial Regional Hospital/Joe DiMaggio Children's Hospital
        • Principal Investigator:
          • Atif M. Hussein
        • Contact:
          • Site Public Contact
          • Phone Number: 954-265-1847
          • Email: OHR@mhs.net
      • Jacksonville, Florida, United States, 32207
        • Active, not recruiting
        • Baptist MD Anderson Cancer Center
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami Miller School of Medicine-Sylvester Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 305-243-2647
        • Principal Investigator:
          • Gregory J. Kubicek
      • Miami, Florida, United States, 33176
        • Active, not recruiting
        • Miami Cancer Institute
      • Orlando, Florida, United States, 32803
        • Recruiting
        • AdventHealth Orlando
        • Principal Investigator:
          • Carlos A. Alemany
        • Contact:
      • Orlando, Florida, United States, 32822
        • Recruiting
        • AdventHealth East Orlando
        • Principal Investigator:
          • Carlos A. Alemany
        • Contact:
          • Site Public Contact
          • Phone Number: 407-303-8110
      • Pembroke Pines, Florida, United States, 33028
        • Recruiting
        • Memorial Hospital West
        • Principal Investigator:
          • Atif M. Hussein
        • Contact:
          • Site Public Contact
          • Phone Number: 954-265-4325
      • Plantation, Florida, United States, 33324
        • Recruiting
        • UM Sylvester Comprehensive Cancer Center at Plantation
        • Contact:
          • Site Public Contact
          • Phone Number: 305-243-2647
        • Principal Investigator:
          • Gregory J. Kubicek
      • Tampa, Florida, United States, 33612
        • Suspended
        • Moffitt Cancer Center
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University Hospital/Winship Cancer Institute
        • Contact:
          • Site Public Contact
          • Phone Number: 404-778-1868
        • Principal Investigator:
          • Bree R. Eaton
      • Atlanta, Georgia, United States, 30303
        • Recruiting
        • Grady Health System
        • Contact:
          • Site Public Contact
          • Phone Number: 404-778-1868
        • Principal Investigator:
          • Bree R. Eaton
      • Atlanta, Georgia, United States, 30342
        • Recruiting
        • Emory Saint Joseph's Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 404-851-7115
        • Principal Investigator:
          • Bree R. Eaton
      • Atlanta, Georgia, United States, 30308
        • Recruiting
        • Emory Proton Therapy Center
        • Contact:
        • Principal Investigator:
          • Bree R. Eaton
      • Atlanta, Georgia, United States, 30309
        • Recruiting
        • Piedmont Hospital
        • Contact:
        • Principal Investigator:
          • Adam W. Nowlan
      • Atlanta, Georgia, United States, 30342
        • Active, not recruiting
        • Northside Hospital
      • Cumming, Georgia, United States, 30041
        • Active, not recruiting
        • Northside Hospital-Forsyth
      • Fayetteville, Georgia, United States, 30214
        • Recruiting
        • Piedmont Fayette Hospital
        • Contact:
        • Principal Investigator:
          • Adam W. Nowlan
      • Newnan, Georgia, United States, 30265
        • Recruiting
        • Piedmont Newnan Hospital
        • Principal Investigator:
          • Adam W. Nowlan
        • Contact:
      • Stockbridge, Georgia, United States, 30281
        • Recruiting
        • Piedmont Henry Hospital
        • Principal Investigator:
          • Adam W. Nowlan
        • Contact:
          • Site Public Contact
          • Phone Number: 404-425-1800
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • Recruiting
        • Queen's Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 808-545-8548
        • Principal Investigator:
          • Richard Y. Lee
      • Honolulu, Hawaii, United States, 96817
        • Recruiting
        • The Cancer Center of Hawaii-Liliha
        • Contact:
          • Site Public Contact
          • Phone Number: 808-547-6881
        • Principal Investigator:
          • Richard Y. Lee
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University
        • Contact:
        • Principal Investigator:
          • Sean Sachdev
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • University of Illinois
        • Contact:
          • Site Public Contact
          • Phone Number: 312-355-3046
        • Principal Investigator:
          • Matthew Koshy
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • Rush MD Anderson Cancer Center
        • Principal Investigator:
          • Ken Tatebe
        • Contact:
      • Decatur, Illinois, United States, 62526
        • Active, not recruiting
        • Decatur Memorial Hospital
      • Evanston, Illinois, United States, 60201
        • Suspended
        • NorthShore University HealthSystem-Evanston Hospital
      • Geneva, Illinois, United States, 60134
        • Recruiting
        • Northwestern Medicine Cancer Center Delnor
        • Contact:
        • Principal Investigator:
          • Vinai Gondi
      • Glenview, Illinois, United States, 60026
        • Suspended
        • NorthShore University HealthSystem-Glenbrook Hospital
      • Highland Park, Illinois, United States, 60035
        • Suspended
        • NorthShore University HealthSystem-Highland Park Hospital
      • Maywood, Illinois, United States, 60153
        • Recruiting
        • Loyola University Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 708-226-4357
        • Principal Investigator:
          • Anupama Chundury
      • Warrenville, Illinois, United States, 60555
        • Recruiting
        • Northwestern Medicine Cancer Center Warrenville
        • Contact:
        • Principal Investigator:
          • Vinai Gondi
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Active, not recruiting
        • Indiana University/Melvin and Bren Simon Cancer Center
      • Indianapolis, Indiana, United States, 46202
        • Active, not recruiting
        • IU Health Methodist Hospital
    • Iowa
      • Des Moines, Iowa, United States, 50309
        • Recruiting
        • Iowa Methodist Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-6727
        • Principal Investigator:
          • Seema Harichand-Herdt
      • Iowa City, Iowa, United States, 52242
        • Active, not recruiting
        • University of Iowa/Holden Comprehensive Cancer Center
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Active, not recruiting
        • University of Kansas Cancer Center
      • Overland Park, Kansas, United States, 66210
        • Active, not recruiting
        • University of Kansas Cancer Center-Overland Park
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Active, not recruiting
        • University of Kentucky/Markey Cancer Center
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • The James Graham Brown Cancer Center at University of Louisville
        • Contact:
          • Site Public Contact
          • Phone Number: 502-562-3429
        • Principal Investigator:
          • Adrianna H. Masters
      • Louisville, Kentucky, United States, 40245
        • Recruiting
        • UofL Health Medical Center Northeast
        • Contact:
        • Principal Investigator:
          • Adrianna H. Masters
    • Louisiana
      • Shreveport, Louisiana, United States, 71103
        • Active, not recruiting
        • LSU Health Sciences Center at Shreveport
    • Maine
      • Bath, Maine, United States, 04530
        • Recruiting
        • MaineHealth Coastal Cancer Treatment Center
        • Contact:
        • Principal Investigator:
          • Matthew D. Cheney
      • Portland, Maine, United States, 04102
        • Recruiting
        • MaineHealth Maine Medical Center - Portland
        • Principal Investigator:
          • Matthew D. Cheney
        • Contact:
      • Sanford, Maine, United States, 04073
        • Recruiting
        • MaineHealth Cancer Care Center of York County
        • Principal Investigator:
          • Matthew D. Cheney
        • Contact:
          • Site Public Contact
          • Phone Number: 207-459-1600
      • Scarborough, Maine, United States, 04074
        • Recruiting
        • MaineHealth Maine Medical Center- Scarborough
        • Principal Investigator:
          • Matthew D. Cheney
        • Contact:
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Active, not recruiting
        • University of Maryland/Greenebaum Cancer Center
      • Baltimore, Maryland, United States, 21201
        • Active, not recruiting
        • Maryland Proton Treatment Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Active, not recruiting
        • University of Michigan Rogel Cancer Center
      • Ann Arbor, Michigan, United States, 48106
        • Suspended
        • Trinity Health Saint Joseph Mercy Hospital Ann Arbor
      • Chelsea, Michigan, United States, 48118
        • Suspended
        • Chelsea Hospital
      • Clinton Township, Michigan, United States, 48038
        • Recruiting
        • Henry Ford Macomb Hospital-Clinton Township
        • Contact:
        • Principal Investigator:
          • Eleanor M. Walker
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Hospital
        • Contact:
        • Principal Investigator:
          • Eleanor M. Walker
      • Detroit, Michigan, United States, 48236
        • Suspended
        • Henry Ford Health Saint John Hospital
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Trinity Health Grand Rapids Hospital
        • Contact:
        • Principal Investigator:
          • Kathleen Y. Butler
      • Livonia, Michigan, United States, 48154
        • Suspended
        • Trinity Health Saint Mary Mercy Livonia Hospital
      • Saginaw, Michigan, United States, 48601
        • Suspended
        • MyMichigan Medical Center Saginaw
      • Warren, Michigan, United States, 48093
        • Suspended
        • Henry Ford Health Warren Hospital
      • West Bloomfield, Michigan, United States, 48322
        • Recruiting
        • Henry Ford West Bloomfield Hospital
        • Contact:
        • Principal Investigator:
          • Eleanor M. Walker
      • Wyoming, Michigan, United States, 49519
        • Recruiting
        • University of Michigan Health - West
        • Contact:
        • Principal Investigator:
          • Kathleen Y. Butler
    • Minnesota
      • Duluth, Minnesota, United States, 55805
        • Recruiting
        • Essentia Health Cancer Center
        • Contact:
        • Principal Investigator:
          • Bret E. Friday
      • Duluth, Minnesota, United States, 55805
        • Recruiting
        • Miller-Dwan Hospital
        • Contact:
        • Principal Investigator:
          • Bret E. Friday
      • Minneapolis, Minnesota, United States, 55407
        • Recruiting
        • Abbott-Northwestern Hospital
        • Contact:
        • Principal Investigator:
          • Yan Ji
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic in Rochester
        • Contact:
          • Site Public Contact
          • Phone Number: 855-776-0015
        • Principal Investigator:
          • Kenneth W. Merrell
      • Saint Louis Park, Minnesota, United States, 55416
        • Recruiting
        • Park Nicollet Clinic - Saint Louis Park
        • Contact:
        • Principal Investigator:
          • Yan Ji
      • Saint Paul, Minnesota, United States, 55101
        • Recruiting
        • Regions Hospital
        • Contact:
        • Principal Investigator:
          • Yan Ji
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Active, not recruiting
        • University of Mississippi Medical Center
    • Missouri
      • City of Saint Peters, Missouri, United States, 63376
        • Recruiting
        • Siteman Cancer Center at Saint Peters Hospital
        • Contact:
        • Principal Investigator:
          • Jiayi Huang
      • Columbia, Missouri, United States, 65212
        • Active, not recruiting
        • MU Health - University Hospital/Ellis Fischel Cancer Center
      • Creve Coeur, Missouri, United States, 63141
        • Recruiting
        • Siteman Cancer Center at West County Hospital
        • Contact:
        • Principal Investigator:
          • Jiayi Huang
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Contact:
        • Principal Investigator:
          • Jiayi Huang
      • St Louis, Missouri, United States, 63129
        • Recruiting
        • Siteman Cancer Center-South County
        • Contact:
        • Principal Investigator:
          • Jiayi Huang
    • Montana
      • Billings, Montana, United States, 59101
        • Suspended
        • Billings Clinic Cancer Center
      • Great Falls, Montana, United States, 59405
        • Recruiting
        • Benefis Sletten Cancer Institute
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Kalispell, Montana, United States, 59901
        • Suspended
        • Logan Health Medical Center
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Active, not recruiting
        • University of Nebraska Medical Center
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Recruiting
        • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
        • Contact:
        • Principal Investigator:
          • Gregory A. Russo
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Active, not recruiting
        • Memorial Sloan Kettering Basking Ridge
      • Middletown, New Jersey, United States, 07748
        • Active, not recruiting
        • Memorial Sloan Kettering Monmouth
      • Montvale, New Jersey, United States, 07645
        • Active, not recruiting
        • Memorial Sloan Kettering Bergen
      • Neptune City, New Jersey, United States, 07753
        • Recruiting
        • Jersey Shore Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 732-776-4240
        • Principal Investigator:
          • Carlos Eduardo Silva Correia
      • New Brunswick, New Jersey, United States, 08903
        • Recruiting
        • Rutgers Cancer Institute of New Jersey
        • Contact:
          • Site Public Contact
          • Phone Number: 732-235-7356
        • Principal Investigator:
          • Bruce G. Haffty
      • Newark, New Jersey, United States, 07101
        • Suspended
        • Rutgers New Jersey Medical School
      • Pennington, New Jersey, United States, 08534
        • Recruiting
        • Capital Health Medical Center-Hopewell
        • Contact:
        • Principal Investigator:
          • Navid Redjal
      • Somerset, New Jersey, United States, 08873
        • Active, not recruiting
        • ProCure Proton Therapy Center-Somerset
      • Somerville, New Jersey, United States, 08876
        • Active, not recruiting
        • Robert Wood Johnson University Hospital Somerset
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Recruiting
        • University of New Mexico Cancer Center
        • Contact:
        • Principal Investigator:
          • Benny J. Liem
    • New York
      • Brooklyn, New York, United States, 11215
        • Recruiting
        • New York-Presbyterian/Brooklyn Methodist Hospital
        • Contact:
        • Principal Investigator:
          • Hani L. Ashamalla
      • Commack, New York, United States, 11725
        • Active, not recruiting
        • Memorial Sloan Kettering Commack
      • East White Plains, New York, United States, 10604
        • Active, not recruiting
        • Memorial Sloan Kettering Westchester
      • Flushing, New York, United States, 11355
        • Active, not recruiting
        • The New York Hospital Medical Center of Queens
      • New York, New York, United States, 10065
        • Recruiting
        • NYP/Weill Cornell Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 212-746-1848
        • Principal Investigator:
          • Jonathan P. Knisely
      • New York, New York, United States, 10032
        • Active, not recruiting
        • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
      • New York, New York, United States, 10065
        • Active, not recruiting
        • Memorial Sloan Kettering Cancer Center
      • Rochester, New York, United States, 14642
        • Active, not recruiting
        • University of Rochester
      • Uniondale, New York, United States, 11553
        • Active, not recruiting
        • Memorial Sloan Kettering Nassau
      • Valhalla, New York, United States, 10595
        • Recruiting
        • Westchester Medical Center
        • Contact:
        • Principal Investigator:
          • Keith Meritz
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Active, not recruiting
        • UNC Lineberger Comprehensive Cancer Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic Foundation
        • Contact:
        • Principal Investigator:
          • John H. Suh
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • Case Western Reserve University
        • Principal Investigator:
          • Prashant Vempati
        • Contact:
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Ohio State University Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Joshua D. Palmer
      • Elyria, Ohio, United States, 44035
        • Suspended
        • Mercy Cancer Center-Elyria
      • Kettering, Ohio, United States, 45429
        • Active, not recruiting
        • Kettering Medical Center
      • Mentor, Ohio, United States, 44060
        • Recruiting
        • UH Seidman Cancer Center at Lake Health Mentor Campus
        • Principal Investigator:
          • Prashant Vempati
        • Contact:
      • Sylvania, Ohio, United States, 43560
        • Recruiting
        • ProMedica Flower Hospital
        • Contact:
        • Principal Investigator:
          • Steven J. Rubin
      • Westlake, Ohio, United States, 44145
        • Recruiting
        • UHHS-Westlake Medical Center
        • Principal Investigator:
          • Prashant Vempati
        • Contact:
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • University of Oklahoma Health Sciences Center
        • Contact:
        • Principal Investigator:
          • J. S. Thompson
    • Oregon
      • Gresham, Oregon, United States, 97030
        • Active, not recruiting
        • Legacy Mount Hood Medical Center
      • Portland, Oregon, United States, 97210
        • Active, not recruiting
        • Legacy Good Samaritan Hospital and Medical Center
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • Active, not recruiting
        • Saint Luke's University Hospital-Bethlehem Campus
      • Chadds Ford, Pennsylvania, United States, 19317
        • Active, not recruiting
        • Christiana Care Health System-Concord Health Center
      • Danville, Pennsylvania, United States, 17822
        • Recruiting
        • Geisinger Medical Center
        • Contact:
        • Principal Investigator:
          • Heath B. Mackley
      • Lewisburg, Pennsylvania, United States, 17837
        • Recruiting
        • Geisinger Medical Oncology-Lewisburg
        • Contact:
        • Principal Investigator:
          • Heath B. Mackley
      • Lewistown, Pennsylvania, United States, 17044
        • Recruiting
        • Lewistown Hospital
        • Contact:
        • Principal Investigator:
          • Heath B. Mackley
      • Philadelphia, Pennsylvania, United States, 19107
        • Active, not recruiting
        • Thomas Jefferson University Hospital
      • Philadelphia, Pennsylvania, United States, 19140
        • Suspended
        • Temple University Hospital
      • Philadelphia, Pennsylvania, United States, 19111
        • Active, not recruiting
        • Fox Chase Cancer Center
      • Pottsville, Pennsylvania, United States, 17901
        • Recruiting
        • Geisinger Cancer Services-Pottsville
        • Contact:
        • Principal Investigator:
          • Heath B. Mackley
      • Wilkes-Barre, Pennsylvania, United States, 18711
        • Recruiting
        • Geisinger Wyoming Valley/Henry Cancer Center
        • Contact:
        • Principal Investigator:
          • Heath B. Mackley
      • Wynnewood, Pennsylvania, United States, 19096
        • Suspended
        • Lankenau Medical Center
    • South Carolina
      • Boiling Springs, South Carolina, United States, 29316
        • Active, not recruiting
        • Prisma Health Cancer Institute - Spartanburg
      • Charleston, South Carolina, United States, 29425
        • Active, not recruiting
        • Medical University of South Carolina
      • Greenville, South Carolina, United States, 29605
        • Active, not recruiting
        • Prisma Health Cancer Institute - Faris
      • Greenville, South Carolina, United States, 29615
        • Active, not recruiting
        • Prisma Health Cancer Institute - Eastside
      • Greer, South Carolina, United States, 29650
        • Active, not recruiting
        • Prisma Health Cancer Institute - Greer
      • Seneca, South Carolina, United States, 29672
        • Active, not recruiting
        • Prisma Health Cancer Institute - Seneca
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Active, not recruiting
        • Vanderbilt University/Ingram Cancer Center
    • Texas
      • Dallas, Texas, United States, 75390
        • Recruiting
        • UT Southwestern/Simmons Cancer Center-Dallas
        • Contact:
        • Principal Investigator:
          • Zabi Wardak
      • Houston, Texas, United States, 77030
        • Withdrawn
        • M D Anderson Cancer Center
      • San Antonio, Texas, United States, 78229
        • Active, not recruiting
        • University of Texas Health Science Center at San Antonio
    • Utah
      • American Fork, Utah, United States, 84003
        • Recruiting
        • American Fork Hospital / Huntsman Intermountain Cancer Center
        • Principal Investigator:
          • Grant K. Hunter
        • Contact:
      • Logan, Utah, United States, 84321
        • Recruiting
        • Logan Regional Hospital
        • Principal Investigator:
          • Grant K. Hunter
        • Contact:
      • Murray, Utah, United States, 84107
        • Recruiting
        • Intermountain Medical Center
        • Principal Investigator:
          • Grant K. Hunter
        • Contact:
      • Ogden, Utah, United States, 84403
        • Recruiting
        • McKay-Dee Hospital Center
        • Principal Investigator:
          • Grant K. Hunter
        • Contact:
      • Provo, Utah, United States, 84604
        • Recruiting
        • Utah Valley Regional Medical Center
        • Principal Investigator:
          • Grant K. Hunter
        • Contact:
      • Riverton, Utah, United States, 84065
        • Recruiting
        • Riverton Hospital
        • Principal Investigator:
          • Grant K. Hunter
        • Contact:
      • Salt Lake City, Utah, United States, 84143
        • Recruiting
        • LDS Hospital
        • Principal Investigator:
          • Grant K. Hunter
        • Contact:
    • Vermont
      • Saint Johnsbury, Vermont, United States, 05819
        • Recruiting
        • Dartmouth Cancer Center - North
        • Contact:
        • Principal Investigator:
          • Gregory A. Russo
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Active, not recruiting
        • VCU Massey Comprehensive Cancer Center
    • Washington
      • Seattle, Washington, United States, 98195
        • Active, not recruiting
        • University of Washington Medical Center - Montlake
      • Vancouver, Washington, United States, 98686
        • Active, not recruiting
        • Legacy Salmon Creek Hospital
    • Wisconsin
      • Antigo, Wisconsin, United States, 54409
        • Recruiting
        • Langlade Hospital and Cancer Center
        • Contact:
        • Principal Investigator:
          • Andrew J. Huang
      • Eau Claire, Wisconsin, United States, 54701
      • Madison, Wisconsin, United States, 53792
        • Recruiting
        • University of Wisconsin Carbone Cancer Center - University Hospital
        • Contact:
        • Principal Investigator:
          • Brett A. Morris
      • Madison, Wisconsin, United States, 53718
        • Recruiting
        • University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
        • Contact:
        • Principal Investigator:
          • Brett A. Morris
      • Marshfield, Wisconsin, United States, 54449
      • Menomonee Falls, Wisconsin, United States, 53051
        • Recruiting
        • Froedtert Menomonee Falls Hospital
        • Principal Investigator:
          • Jennifer M. Connelly
        • Contact:
          • Site Public Contact
          • Phone Number: 262-257-5100
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin
        • Principal Investigator:
          • Jennifer M. Connelly
        • Contact:
          • Site Public Contact
          • Phone Number: 414-805-3666
      • Minocqua, Wisconsin, United States, 54548
      • Oak Creek, Wisconsin, United States, 53154
        • Recruiting
        • Drexel Town Square Health Center
        • Principal Investigator:
          • Jennifer M. Connelly
        • Contact:
          • Site Public Contact
          • Phone Number: 414-805-0505
      • Rice Lake, Wisconsin, United States, 54868
      • Stevens Point, Wisconsin, United States, 54482
      • Stevens Point, Wisconsin, United States, 54481
        • Recruiting
        • Aspirus Cancer Care - Stevens Point
        • Principal Investigator:
          • Andrew J. Huang
        • Contact:
      • Waukesha, Wisconsin, United States, 53188
        • Recruiting
        • UW Cancer Center at ProHealth Care
        • Principal Investigator:
          • Timothy R. Wassenaar
        • Contact:
      • Wausau, Wisconsin, United States, 54401
        • Recruiting
        • Aspirus Regional Cancer Center
        • Principal Investigator:
          • Andrew J. Huang
        • Contact:
          • Site Public Contact
          • Phone Number: 877-405-6866
      • Weston, Wisconsin, United States, 54476
      • Wisconsin Rapids, Wisconsin, United States, 54494
        • Recruiting
        • Aspirus Cancer Care - Wisconsin Rapids
        • Principal Investigator:
          • Andrew J. Huang
        • Contact:
          • Site Public Contact
          • Phone Number: 715-422-7718

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm I (observation)
Patients undergo observation. Additionally, patients undergo MRI and blood collection throughout the study.
Other: Laboratory Biomarker Analysis
Correlative studies
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Procedure: Biospecimen Collection
Undergo collection of blood samples
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
Procedure: Magnetic Resonance Imaging
Undergo MRI
Other Names:
  • MRI
  • Magnetic Resonance
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MR
  • MR Imaging
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging
  • Magnetic Resonance Imaging (MRI)
  • sMRI
  • Magnetic resonance imaging (procedure)
  • MRIs
  • Structural MRI
Other: Clinical Observation
Undergo observation
Other Names:
  • observation
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.
Other: Laboratory Biomarker Analysis
Correlative studies
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Procedure: Biospecimen Collection
Undergo collection of blood samples
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
Procedure: Magnetic Resonance Imaging
Undergo MRI
Other Names:
  • MRI
  • Magnetic Resonance
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MR
  • MR Imaging
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging
  • Magnetic Resonance Imaging (MRI)
  • sMRI
  • Magnetic resonance imaging (procedure)
  • MRIs
  • Structural MRI
Radiation: Intensity-Modulated Radiation Therapy
Undergo IMRT
Other Names:
  • IMRT
  • Intensity Modulated RT
  • Intensity-Modulated Radiotherapy
  • Radiation, Intensity-Modulated Radiotherapy
  • Intensity modulated radiation therapy (procedure)
Radiation: Proton Beam Radiation Therapy
Undergo proton beam radiation therapy
Other Names:
  • Proton Radiation Therapy
  • PBRT
  • Proton
  • Proton EBRT
  • Proton External Beam Radiotherapy
  • Radiation, Proton Beam
  • PROTON Therapy
  • External beam radiation therapy protons (procedure)
  • External Beam Radiotherapy (protons)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
From randomization to the first documented disease progression, or death due to any cause, whichever comes first, assessed up to 10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS
Time Frame: From randomization to the first documented disease progression, or death due to any cause, whichever comes first, assessed at 3 years
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.
From randomization to the first documented disease progression, or death due to any cause, whichever comes first, assessed at 3 years
PFS
Time Frame: From randomization to the first documented disease progression, or death due to any cause, whichever comes first, assessed up to 5 years
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.
From randomization to the first documented disease progression, or death due to any cause, whichever comes first, assessed up to 5 years
Disease-specific survival (DSS)
Time Frame: From randomization to disease-related death, assessed up to 10 years
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.
From randomization to disease-related death, assessed up to 10 years
DSS rates
Time Frame: At 3 years
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.
At 3 years
DSS rates
Time Frame: At 5 years
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.
At 5 years
Overall survival (OS)
Time Frame: From randomization to death due to any cause, assessed up to 10 years
Cox proportional hazard model will be used to determine the adjusted treatment effect on OS, with patient pretreatment characteristics as covariates.
From randomization to death due to any cause, assessed up to 10 years
OS rates
Time Frame: At 5 years
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.
At 5 years
Incidence of adverse events (exclusive of alopecia)
Time Frame: Up to 3 years
Will be measured by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4 (version 5 beginning April 5, 2018).
Up to 3 years
Adherence rate to protocol-specific target and normal tissue parameters
Time Frame: Up to 10 years
Up to 10 years
Concordance rate of central versus parent-institution pathology
Time Frame: Up to 10 years
Up to 10 years
Prognostic value of 34-gene expression biomarker
Time Frame: Up to 5 years
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.
Up to 5 years
Predictive value of 34-gene expression biomarker
Time Frame: Up to 5 years
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.
Up to 5 years
Change in neurocognitive function (NCF) assessed by MD Anderson Symptom Inventory with Brain Tumor (MDASI-BT)
Time Frame: Baseline up to 60 months
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.
Baseline up to 60 months
Change in patient reported outcomes (PRO) as assessed by MDASI-BT
Time Frame: Baseline up to 60 months
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.
Baseline up to 60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NRG Oncology

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Michael A Vogelbaum, NRG Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 12, 2017

Primary Completion (Estimated)

June 15, 2027

Study Completion (Estimated)

June 15, 2027

Study Registration Dates

First Submitted

June 6, 2017

First Submitted That Met QC Criteria

June 6, 2017

First Posted (Actual)

June 8, 2017

Study Record Updates

Last Update Posted (Actual)

May 7, 2026

Last Update Submitted That Met QC Criteria

May 5, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NRG-BN003 (Other Identifier: CTEP)
  • U10CA180868 (U.S. NIH Grant/Contract)
  • NCI-2016-01619 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Intracranial Meningioma

Clinical Trials on Laboratory Biomarker Analysis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burkina Faso

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe