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

February 5, 2024 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 OBJECTIVES:

I. To determine, in terms of progression-free survival (PFS), 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. Outcomes and 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. Tissue microarray construction, and assessment of pHH3 mitotic index and molecular correlates to OS.

OUTLINE: Patients are randomized to 1 of 2 arms after undergoing gross total resection.

ARM I: Patients undergo observation.

ARM II: Patients undergo radiation therapy 5 days a week over 6.5-7 weeks for a total of 33 fractions (59.4 Gy in 33 daily fractions of 1.8 Gy each).

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)

148

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 4N2
        • Suspended
        • Tom Baker Cancer Centre
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Recruiting
        • Cross Cancer Institute
        • Contact:
          • Site Public Contact
          • Phone Number: 780-432-8500
        • Principal Investigator:
          • Samir I. Patel
    • 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
        • Suspended
        • The Research Institute of the McGill University Health Centre (MUHC)
      • 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
        • Recruiting
        • Tata Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Tejpal Gupta
  • Japan
      • Hiroshima City, 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
        • Recruiting
        • King Faisal Specialist Hospital and Research Centre
        • Contact:
          • Site Public Contact
          • Phone Number: 38005 011-966-1-464-7272
        • Principal Investigator:
          • Ameen Al-Omair
  • 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, 85719
        • Active, not recruiting
        • Banner University Medical Center - Tucson
      • Tucson, Arizona, United States, 85719
        • Active, not recruiting
        • University of Arizona Cancer Center-North Campus
      • Tucson, Arizona, United States, 85704
        • Recruiting
        • University of Arizona Cancer Center-Orange Grove Campus
        • Contact:
          • Site Public Contact
          • Phone Number: 520-694-8900
        • Principal Investigator:
          • Baldassarre Stea
    • California
      • Anaheim, California, United States, 92806
        • Recruiting
        • Kaiser Permanente-Anaheim
        • Principal Investigator:
          • Michael R. Girvigian
        • Contact:
      • Auburn, California, United States, 95603
        • Recruiting
        • Sutter Cancer Centers Radiation Oncology Services-Auburn
        • Principal Investigator:
          • Christopher U. Jones
        • Contact:
      • 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
        • Principal Investigator:
          • Michael R. Girvigian
        • Contact:
      • 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
        • Principal Investigator:
          • Michael R. Girvigian
        • Contact:
      • Orange, California, United States, 92868
        • Recruiting
        • UC Irvine Health/Chao Family Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Xiao-Tang Kong
      • 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
      • 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
        • Recruiting
        • Yale University
        • 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:
          • Eric A. Mellon
      • 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:
          • Eric A. Mellon
      • Jacksonville, Florida, United States, 32207
        • Recruiting
        • Baptist MD Anderson Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 904-202-7468
        • Principal Investigator:
          • Michael R. Olson
      • 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:
          • Eric A. Mellon
      • Miami, Florida, United States, 33176
        • Active, not recruiting
        • Miami Cancer Institute
      • Orlando, Florida, United States, 32803
        • Recruiting
        • AdventHealth Orlando
        • Contact:
        • Principal Investigator:
          • Sherif Makar
      • Orlando, Florida, United States, 32822
        • Suspended
        • AdventHealth East Orlando
      • Tampa, Florida, United States, 33612
        • Recruiting
        • Moffitt Cancer Center
        • Contact:
        • Principal Investigator:
          • Hsiang-Hsuan M. Yu
    • 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: 404-489-9164
        • 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, 60612
        • Recruiting
        • Rush University Medical Center
        • Contact:
        • Principal Investigator:
          • Ken Tatebe
      • 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
      • Decatur, Illinois, United States, 62526
        • Active, not recruiting
        • Decatur Memorial Hospital
      • Evanston, Illinois, United States, 60201
        • Recruiting
        • NorthShore University HealthSystem-Evanston Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 847-570-2109
        • Principal Investigator:
          • Bruce E. Brockstein
      • Geneva, Illinois, United States, 60134
        • Recruiting
        • Northwestern Medicine Cancer Center Delnor
        • Contact:
        • Principal Investigator:
          • Vinai Gondi
      • Glenview, Illinois, United States, 60026
        • Recruiting
        • NorthShore University HealthSystem-Glenbrook Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 847-570-2109
        • Principal Investigator:
          • Bruce E. Brockstein
      • Highland Park, Illinois, United States, 60035
        • Recruiting
        • NorthShore University HealthSystem-Highland Park Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 847-570-2109
        • Principal Investigator:
          • Bruce E. Brockstein
      • 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
        • Active, not recruiting
        • Iowa Methodist Medical Center
      • 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
    • Louisiana
      • Shreveport, Louisiana, United States, 71103
        • Recruiting
        • LSU Health Sciences Center at Shreveport
        • Contact:
        • Principal Investigator:
          • Gary V. Burton
    • Maine
      • Bath, Maine, United States, 04530
        • Recruiting
        • MaineHealth Coastal Cancer Treatment Center
        • Contact:
        • Principal Investigator:
          • Matthew D. Cheney
      • Portland, Maine, United States, 04102
        • Recruiting
        • Maine Medical Center-Bramhall Campus
        • Principal Investigator:
          • Matthew D. Cheney
        • Contact:
          • Site Public Contact
          • Phone Number: 207-885-7565
      • 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
        • Maine Medical Center- Scarborough Campus
        • Contact:
          • Site Public Contact
          • Phone Number: 207-396-8090
          • Email: wrighd@mmc.org
        • Principal Investigator:
          • Matthew D. Cheney
    • 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 Comprehensive Cancer Center
      • Ann Arbor, Michigan, United States, 48106
        • Suspended
        • Saint Joseph Mercy Hospital
      • Chelsea, Michigan, United States, 48118
        • Suspended
        • Saint Joseph Mercy Chelsea
      • 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
        • Ascension Saint John Hospital
      • Livonia, Michigan, United States, 48154
        • Suspended
        • Trinity Health Saint Mary Mercy Livonia Hospital
      • Saginaw, Michigan, United States, 48601
        • Recruiting
        • Ascension Saint Mary's Hospital
        • Contact:
        • Principal Investigator:
          • Samir Narayan
      • Warren, Michigan, United States, 48093
        • Suspended
        • Saint John Macomb-Oakland Hospital
      • West Bloomfield, Michigan, United States, 48322
        • Recruiting
        • Henry Ford West Bloomfield Hospital
        • Contact:
        • Principal Investigator:
          • Eleanor M. Walker
    • 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
        • Active, not recruiting
        • Mayo Clinic in Rochester
      • 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
      • Columbia, Missouri, United States, 65212
        • Recruiting
        • MU Health - University Hospital/Ellis Fischel Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 573-882-7440
        • Principal Investigator:
          • Gregory B. Biedermann
      • Creve Coeur, Missouri, United States, 63141
        • Recruiting
        • Siteman Cancer Center at West County Hospital
        • Contact:
        • Principal Investigator:
          • Jiayi Huang
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Contact:
        • Principal Investigator:
          • Jiayi Huang
      • Saint Louis, Missouri, United States, 63129
        • Recruiting
        • Siteman Cancer Center-South County
        • Contact:
        • Principal Investigator:
          • Jiayi Huang
      • Saint Peters, Missouri, United States, 63376
        • Recruiting
        • Siteman Cancer Center at Saint Peters Hospital
        • Contact:
        • Principal Investigator:
          • Jiayi Huang
    • Montana
      • Great Falls, Montana, United States, 59405
        • Recruiting
        • Benefis Healthcare- Sletten Cancer Institute
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Kalispell, Montana, United States, 59901
        • Recruiting
        • Kalispell Regional Medical Center
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
    • 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
      • 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, 87102
        • 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
      • Flushing, New York, United States, 11355
        • Active, not recruiting
        • The New York Hospital Medical Center of Queens
      • Harrison, New York, United States, 10604
        • Active, not recruiting
        • Memorial Sloan Kettering Westchester
      • 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
      • New York, New York, United States, 10065
        • Suspended
        • NYP/Weill Cornell Medical 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
      • 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, 19140
        • Recruiting
        • Temple University Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 215-728-2983
        • Principal Investigator:
          • Curtis T. Miyamoto
      • Philadelphia, Pennsylvania, United States, 19107
        • Active, not recruiting
        • Thomas Jefferson 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
        • Suspended
        • 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
        • Suspended
        • Prisma Health Cancer Institute - Faris
      • Greenville, South Carolina, United States, 29615
        • Suspended
        • Prisma Health Cancer Institute - Eastside
      • Greer, South Carolina, United States, 29650
        • Suspended
        • Prisma Health Cancer Institute - Greer
      • Seneca, South Carolina, United States, 29672
        • Suspended
        • 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
        • Norris Cotton Cancer Center-North
        • Contact:
        • Principal Investigator:
          • Gregory A. Russo
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Active, not recruiting
        • Virginia Commonwealth University/Massey 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
        • Contact:
          • Site Public Contact
          • Phone Number: 800-622-8922
        • Principal Investigator:
          • Steven P. Howard
      • 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
        • Ascension Saint Michael's Hospital
        • Principal Investigator:
          • Andrew J. Huang
        • 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
  • Step 1 registration must occur within 180 days of the initial surgery; 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
  • For step 1 registration the operating neurosurgeon must provide the modified Simpson grade
  • GTR must be confirmed on post-operative imaging following the most recent surgery; 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; imaging subsequent to enrollment must include pre and post gadolinium contrast-enhanced three-dimensional spoiled gradient (SPGR), magnetization-prepared rapid gradient echo (MP-RAGE), or turbo field echo (TFE) MRI scan and an axial T2 fluid attenuated inversion recovery (FLAIR) sequence; to yield acceptable image quality, the gadolinium contrast-enhanced three-dimensional SPGR, MP-RAGE, or TFE axial MRI scan should use the smallest possible axial slice thickness not exceeding 1.5 mm; 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
  • If the patient is a primary English speaker, the patient must participate in the NCF and patient reported outcomes part of the study; if the patient is a primary French or Spanish speaker, the patient must participate in the patient reported outcomes part of the study
  • 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 15 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
  • 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
  • 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, etc) or receive gadolinium; 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
  • Pregnancy and/or nursing females

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
Other: Arm I (Clinical Observation)
Patients undergo observation after gross total resection.
Other: Clinical Observation
Undergo observation
Experimental: Arm II (Radiation Therapy)
Patients undergo radiation therapy 5 days a week over 6.5-7 weeks for a total of 33 fractions after gross total resection.
Radiation: Radiation Therapy
Undergo radiation therapy
Other Names:
  • Cancer Radiotherapy
  • Irradiate
  • Irradiated
  • Irradiation
  • Radiotherapeutics
  • Radiotherapy
  • RT
  • Therapy, Radiation
  • RADIATION

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 (Kaplan 1958). Hazard ratio (HR) on the treatment effect will be calculated using the Cox proportional hazard model (Cox 1972). A one-sided log-rank test will be used to test the difference in PFS between the two arms (Peto 1972).
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
Overall Survival (OS)
Time Frame: From randomization to death due to any cause, assessed up to 10 years
Kaplan-Meier method will be used to calculate the OS rates for each of the two arms (Kaplan 1958). Hazard ratio (HR) on the treatment effect will be calculated using the Cox proportional hazard model (Cox 1972). A one-sided log-rank test will be used to test the difference in OS between the two arms (Peto 1972). 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
5 Year Overall Survival (OS)
Time Frame: At 5 years after randomization
Will be calculated based on the Kaplan-Meier curve.
At 5 years after randomization
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 (Gray 1988). Multivariate analysis on DSS will be performed using the Fine-Gray model, with patient pretreatment characteristics as covariates (Fine 1999).
From randomization to disease-related death, assessed up to 10 years
3 Year Disease-Specific Survival (DSS)
Time Frame: At 3 years after randomization
Will be calculated using the cumulative incidence function for each arm.
At 3 years after randomization
5 Year Disease-Specific Survival (DSS)
Time Frame: At 5 years after randomization
Will be calculated using the cumulative incidence function for each arm.
At 5 years after randomization
3 Year Progression-Free Survival (PFS)
Time Frame: From randomization to the first documented disease progression, or death due to any cause, whichever comes first, assessed at 3 years after randomization.
Will be calculated based on the Kaplan-Meier curve.
From randomization to the first documented disease progression, or death due to any cause, whichever comes first, assessed at 3 years after randomization.
5 Year 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 5 years after randomization.
Will be calculated based on the Kaplan-Meier curve.
From randomization to the first documented disease progression, or death due to any cause, whichever comes first, assessed up to 5 years after randomization.
Neurocognitive Function (NCF)
Time Frame: Baseline up to 60 months after randomization
Longitudinal analysis will be performed to compare NCF over time between the 2 arms, using the NCF Clinical Trial Battery (CTB) composite score. Early change from baseline in CTB composite score will be evaluated and compared between the 2 arms using 2-sample t tests.
Baseline up to 60 months after randomization
Patient Reported Outcomes (PRO) as assessed by MDASI-BT
Time Frame: Baseline up to 60 months after randomization
Longitudinal analysis will be performed to compare symptom burden over time between the 2 arms, using the MDASI-BT. Early change from baseline in symptom burden will be evaluated and compared between the 2 arms using 2-sample t tests.
Baseline up to 60 months after randomization
Assessment of pHH3 mitotic index
Time Frame: Up to 10 years after randomization
The Kaplan-Meier method will be used to estimate the PFS and OS rates by pHH3 category. The HRs on the effect of pHH3 on PFS and OS, respectively will be calculated using the Cox proportional hazard model and will be tested using the log-rank test. Multivariate analyses will be conducted with patient pretreatment characteristics, such as age and Simpson resection grade, included as covariates.
Up to 10 years after randomization
Incidence of adverse events as measured by the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4 (exclusive of alopecia)
Time Frame: Up to 3 years after randomization
The number of adverse events will be measured using the CTCAE, version 4
Up to 3 years after randomization

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: C. Leland Rogers, MD, 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)

June 14, 2017

Primary Completion (Estimated)

June 15, 2027

Study Completion (Estimated)

August 31, 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 (Estimated)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

February 1, 2024

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

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