Observation or Radiation Therapy in Treating Patients With Newly Diagnosed Grade II Meningioma That Has Been Completely Removed by Surgery
Start Date
9/12/2017
Completion Date
6/15/2027
Summary
This randomized phase III trial studies how well radiation therapy works compared with observation in treating patients with newly diagnosed grade II meningioma that has been completely removed by surgery. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors.
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Biospecimen Collection
Clinical Observation
Intensity-Modulated Radiation Therapy
Laboratory Biomarker Analysis
Magnetic Resonance Imaging
Proton Beam Radiation Therapy
Quality-of-Life Assessment
Conditions
Locations
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama 35233
United States
Saint Joseph's Hospital and Medical Center
Phoenix, Arizona 85013
United States
Mayo Clinic Hospital in Arizona
Phoenix, Arizona 85054
United States
Mayo Clinic in Arizona
Scottsdale, Arizona 85259
United States
University of Arizona Cancer Center-Orange Grove Campus
Tucson, Arizona 85704
United States
Banner University Medical Center - Tucson
Tucson, Arizona 85719
United States
University of Arizona Cancer Center-North Campus
Tucson, Arizona 85719
United States
Kaiser Permanente-Anaheim
Anaheim, California 92806
United States
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn, California 95603
United States
Kaiser Permanente-Bellflower
Bellflower, California 90706
United States
Kaiser Permanente Dublin
Dublin, California 94568
United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California 90027
United States
Los Angeles General Medical Center
Los Angeles, California 90033
United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California 90033
United States
Memorial Medical Center
Modesto, California 95355
United States
Kaiser Permanente Oakland-Broadway
Oakland, California 94611
United States
Kaiser Permanente-Ontario
Ontario, California 91761
United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California 92868
United States
Stanford Cancer Institute Palo Alto
Palo Alto, California 94304
United States
Kaiser Permanente-Rancho Cordova Cancer Center
Rancho Cordova, California 95670
United States
Rohnert Park Cancer Center
Rohnert Park, California 94928
United States
Sutter Cancer Centers Radiation Oncology Services-Roseville
Roseville, California 95661
United States
The Permanente Medical Group-Roseville Radiation Oncology
Roseville, California 95678
United States
Sutter Medical Center Sacramento
Sacramento, California 95816
United States
South Sacramento Cancer Center
Sacramento, California 95823
United States
California Pacific Medical Center-Pacific Campus
San Francisco, California 94115
United States
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California 95051
United States
Kaiser Permanente Cancer Treatment Center
South San Francisco, California 94080
United States
Sutter Solano Medical Center/Cancer Center
Vallejo, California 94589
United States
Hartford Hospital
Hartford, Connecticut 06102
United States
Yale University
New Haven, Connecticut 06520
United States
Smilow Cancer Hospital Care Center-Trumbull
Trumbull, Connecticut 06611
United States
Helen F Graham Cancer Center
Newark, Delaware 19713
United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware 19718
United States
Beebe Health Campus
Rehoboth Beach, Delaware 19971
United States
TidalHealth Nanticoke / Allen Cancer Center
Seaford, Delaware 19973
United States
Boca Raton Regional Hospital
Boca Raton, Florida 33486
United States
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida 33146
United States
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida 33442
United States
UM Sylvester Comprehensive Cancer Center at Doral
Doral, Florida 33166
United States
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, Florida 33021
United States
Baptist MD Anderson Cancer Center
Jacksonville, Florida 32207
United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida 33136
United States
Miami Cancer Institute
Miami, Florida 33176
United States
AdventHealth Orlando
Orlando, Florida 32803
United States
AdventHealth East Orlando
Orlando, Florida 32822
United States
Memorial Hospital West
Pembroke Pines, Florida 33028
United States
UM Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida 33324
United States
Moffitt Cancer Center
Tampa, Florida 33612
United States
Grady Health System
Atlanta, Georgia 30303
United States
Emory Proton Therapy Center
Atlanta, Georgia 30308
United States
Piedmont Hospital
Atlanta, Georgia 30309
United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia 30322
United States
Emory Saint Joseph's Hospital
Atlanta, Georgia 30342
United States
Northside Hospital
Atlanta, Georgia 30342
United States
Northside Hospital-Forsyth
Cumming, Georgia 30041
United States
Piedmont Fayette Hospital
Fayetteville, Georgia 30214
United States
Piedmont Newnan Hospital
Newnan, Georgia 30265
United States
Piedmont Henry Hospital
Stockbridge, Georgia 30281
United States
Queen's Medical Center
Honolulu, Hawaii 96813
United States
The Cancer Center of Hawaii-Liliha
Honolulu, Hawaii 96817
United States
Northwestern University
Chicago, Illinois 60611
United States
Rush MD Anderson Cancer Center
Chicago, Illinois 60612
United States
University of Illinois
Chicago, Illinois 60612
United States
Decatur Memorial Hospital
Decatur, Illinois 62526
United States
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois 60201
United States
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois 60134
United States
NorthShore University HealthSystem-Glenbrook Hospital
Glenview, Illinois 60026
United States
NorthShore University HealthSystem-Highland Park Hospital
Highland Park, Illinois 60035
United States
Loyola University Medical Center
Maywood, Illinois 60153
United States
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois 60555
United States
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana 46202
United States
IU Health Methodist Hospital
Indianapolis, Indiana 46202
United States
Iowa Methodist Medical Center
Des Moines, Iowa 50309
United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa 52242
United States
University of Kansas Cancer Center
Kansas City, Kansas 66160
United States
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas 66210
United States
University of Kentucky/Markey Cancer Center
Lexington, Kentucky 40536
United States
The James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky 40202
United States
UofL Health Medical Center Northeast
Louisville, Kentucky 40245
United States
LSU Health Sciences Center at Shreveport
Shreveport, Louisiana 71103
United States
MaineHealth Coastal Cancer Treatment Center
Bath, Maine 04530
United States
MaineHealth Maine Medical Center - Portland
Portland, Maine 04102
United States
MaineHealth Cancer Care Center of York County
Sanford, Maine 04073
United States
MaineHealth Maine Medical Center- Scarborough
Scarborough, Maine 04074
United States
Maryland Proton Treatment Center
Baltimore, Maryland 21201
United States
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland 21201
United States
Tufts Medical Center
Boston, Massachusetts 02111
United States
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan 48106
United States
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan 48109
United States
Chelsea Hospital
Chelsea, Michigan 48118
United States
Henry Ford Macomb Hospital-Clinton Township
Clinton Township, Michigan 48038
United States
Henry Ford Hospital
Detroit, Michigan 48202
United States
Henry Ford Health Saint John Hospital
Detroit, Michigan 48236
United States
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan 49503
United States
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan 48154
United States
MyMichigan Medical Center Saginaw
Saginaw, Michigan 48601
United States
Henry Ford Health Warren Hospital
Warren, Michigan 48093
United States
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan 48322
United States
University of Michigan Health - West
Wyoming, Michigan 49519
United States
Essentia Health Cancer Center
Duluth, Minnesota 55805
United States
Miller-Dwan Hospital
Duluth, Minnesota 55805
United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota 55407
United States
Mayo Clinic in Rochester
Rochester, Minnesota 55905
United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota 55416
United States
Regions Hospital
Saint Paul, Minnesota 55101
United States
University of Mississippi Medical Center
Jackson, Mississippi 39216
United States
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri 63376
United States
MU Health - University Hospital/Ellis Fischel Cancer Center
Columbia, Missouri 65212
United States
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri 63141
United States
Washington University School of Medicine
St Louis, Missouri 63110
United States
Siteman Cancer Center-South County
St Louis, Missouri 63129
United States
Billings Clinic Cancer Center
Billings, Montana 59101
United States
Benefis Sletten Cancer Institute
Great Falls, Montana 59405
United States
Logan Health Medical Center
Kalispell, Montana 59901
United States
University of Nebraska Medical Center
Omaha, Nebraska 68198
United States
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire 03756
United States
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey 07920
United States
Englewood Hospital and Medical Center
Englewood, New Jersey 07631
United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey 07748
United States
Memorial Sloan Kettering Bergen
Montvale, New Jersey 07645
United States
Jersey Shore Medical Center
Neptune City, New Jersey 07753
United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey 08903
United States
Rutgers New Jersey Medical School
Newark, New Jersey 07101
United States
Capital Health Medical Center-Hopewell
Pennington, New Jersey 08534
United States
ProCure Proton Therapy Center-Somerset
Somerset, New Jersey 08873
United States
Robert Wood Johnson University Hospital Somerset
Somerville, New Jersey 08876
United States
University of New Mexico Cancer Center
Albuquerque, New Mexico 87106
United States
New York-Presbyterian/Brooklyn Methodist Hospital
Brooklyn, New York 11215
United States
Memorial Sloan Kettering Commack
Commack, New York 11725
United States
The New York Hospital Medical Center of Queens
Flushing, New York 11355
United States
Memorial Sloan Kettering Westchester
Harrison, New York 10604
United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York 10032
United States
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
NYP/Weill Cornell Medical Center
New York, New York 10065
United States
University of Rochester
Rochester, New York 14642
United States
Memorial Sloan Kettering Nassau
Uniondale, New York 11553
United States
Westchester Medical Center
Valhalla, New York 10595
United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina 27599
United States
Case Western Reserve University
Cleveland, Ohio 44106
United States
Cleveland Clinic Foundation
Cleveland, Ohio 44195
United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
United States
Mercy Cancer Center-Elyria
Elyria, Ohio 44035
United States
Kettering Medical Center
Kettering, Ohio 45429
United States
UH Seidman Cancer Center at Lake Health Mentor Campus
Mentor, Ohio 44060
United States
ProMedica Flower Hospital
Sylvania, Ohio 43560
United States
UHHS-Westlake Medical Center
Westlake, Ohio 44145
United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
United States
Legacy Mount Hood Medical Center
Gresham, Oregon 97030
United States
Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon 97210
United States
Saint Luke's University Hospital-Bethlehem Campus
Bethlehem, Pennsylvania 18015
United States
Christiana Care Health System-Concord Health Center
Chadds Ford, Pennsylvania 19317
United States
Geisinger Medical Center
Danville, Pennsylvania 17822
United States
Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania 17837
United States
Lewistown Hospital
Lewistown, Pennsylvania 17044
United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111
United States
Temple University Hospital
Philadelphia, Pennsylvania 19140
United States
Geisinger Cancer Services-Pottsville
Pottsville, Pennsylvania 17901
United States
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania 18711
United States
Lankenau Medical Center
Wynnewood, Pennsylvania 19096
United States
Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina 29316
United States
Medical University of South Carolina
Charleston, South Carolina 29425
United States
Prisma Health Cancer Institute - Faris
Greenville, South Carolina 29605
United States
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina 29615
United States
Prisma Health Cancer Institute - Greer
Greer, South Carolina 29650
United States
Prisma Health Cancer Institute - Seneca
Seneca, South Carolina 29672
United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee 37232
United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas 75390
United States
UT MD Anderson Cancer Center
Houston, Texas 77030
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas 78229
United States
American Fork Hospital / Huntsman Intermountain Cancer Center
American Fork, Utah 84003
United States
Logan Regional Hospital
Logan, Utah 84321
United States
Intermountain Medical Center
Murray, Utah 84107
United States
McKay-Dee Hospital Center
Ogden, Utah 84403
United States
Utah Valley Regional Medical Center
Provo, Utah 84604
United States
Riverton Hospital
Riverton, Utah 84065
United States
LDS Hospital
Salt Lake City, Utah 84143
United States
Dartmouth Cancer Center - North
Saint Johnsbury, Vermont 05819
United States
VCU Massey Comprehensive Cancer Center
Richmond, Virginia 23298
United States
University of Washington Medical Center - Montlake
Seattle, Washington 98195
United States
Legacy Salmon Creek Hospital
Vancouver, Washington 98686
United States
Langlade Hospital and Cancer Center
Antigo, Wisconsin 54409
United States
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin 54701
United States
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Madison, Wisconsin 53718
United States
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin 53792
United States
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin 54449
United States
Froedtert Menomonee Falls Hospital
Menomonee Falls, Wisconsin 53051
United States
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United States
Marshfield Medical Center - Minocqua
Minocqua, Wisconsin 54548
United States
Drexel Town Square Health Center
Oak Creek, Wisconsin 53154
United States
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin 54868
United States
Aspirus Cancer Care - Stevens Point
Stevens Point, Wisconsin 54481
United States
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin 54482
United States
UW Cancer Center at ProHealth Care
Waukesha, Wisconsin 53188
United States
Aspirus Regional Cancer Center
Wausau, Wisconsin 54401
United States
Marshfield Medical Center - Weston
Weston, Wisconsin 54476
United States
Aspirus Cancer Care - Wisconsin Rapids
Wisconsin Rapids, Wisconsin 54494
United States
Arthur J E Child Comprehensive Cancer Centre
Calgary, Alberta T2N 5G2
Canada
Cross Cancer Institute
Edmonton, Alberta T6G 1Z2
Canada
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario L8V 5C2
Canada
London Regional Cancer Program
London, Ontario N6A 4L6
Canada
University Health Network-Princess Margaret Hospital
Toronto, Ontario M5G 2M9
Canada
CHUM - Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec H2X 3E4
Canada
The Research Institute of the McGill University Health Centre (MUHC)
Montreal, Quebec H3H 2R9
Canada
Allan Blair Cancer Centre
Regina, Saskatchewan S4T 7T1
Canada
Tata Memorial Hospital
Mumbai, 400 012
India
Hokkaido University Hospital
Sapporo, Hokkaido 060-8648
Japan
Iwate Medical University Hospital
Shiwa-gun, Iwate 028-3695
Japan
Kyorin University Hospital
Mitaka-shi, Tokyo 181-8611
Japan
Keio University
Shinjuku-ku, Tokyo 160-8582
Japan
Hiroshima University Hospital
Hiroshima, 734-8551
Japan
Saitama Medical University International Medical Center
Saitama, 350-1298
Japan
National Cancer Center Hospital
Tokyo, 104 0045
Japan
King Faisal Specialist Hospital and Research Centre
Riyadh, 11211
Saudi Arabia