Testing Longer Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients With Cancer That Has Spread to the Brain
Start Date
12/12/2024
Completion Date
6/30/2028
Summary
This phase III trial compares the effectiveness of fractionated stereotactic radiosurgery (FSRS) to usual care stereotactic radiosurgery (SRS) in treating patients with cancer that has spread from where it first started to the brain. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. FSRS delivers a high dose of radiation to the tumor over 3 treatments. SRS is a type of external radiation therapy that uses special equipment to position the patient and precisely give a single large dose of radiation to a tumor. FSRS may be more effective compared to SRS in treating patients with cancer that has spread to the brain.
Detailed Description
PRIMARY OBJECTIVE: I. To determine if the time to local failure is improved with FSRS compared to SRS in patients with intact (i.e., unresected) brain metastases. SECONDARY OBJECTIVES: I. To compare time to intracranial progression-free survival between FSRS and SRS. II. To compare overall survival between FSRS and SRS. III. To determine if the time to local failure is improved with FSRS compared to SRS, as evaluated by central review of imaging. IV. To evaluate if there is any difference in central nervous system (CNS) failure patterns (local versus \[vs.\] distant brain failure vs. both) in patients who receive FSRS compared to patients who receive SRS. V. To compare the rates of radiation necrosis in patients who receive FSRS vs. SRS. VI. To compare the time to salvage whole brain radiation therapy (WBRT) between patients who receive FSRS and those who receive SRS. VII. To compare the rates of post-treatment adverse events associated with FSRS and SRS. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients undergo SRS over 30-90 minutes for 1 fraction on study. Additionally, patients undergo computed tomography (CT) and magnetic resonance imaging (MRI) on study. ARM II: Patients undergo FSRS over 30-90 minutes for 3 fractions on study. Additionally, patients undergo CT and MRI on study. After completion of study treatment, patients are followed up every 3 months for 1 year, every 4 months for 1 year then every 6 months for 3 years.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Computed Tomography
Fractionated Stereotactic Radiation Therapy
Magnetic Resonance Imaging
Stereotactic Radiosurgery
Conditions
Locations
Banner University Medical Center - Tucson
Tucson, Arizona 85719
United States
University of Arizona Cancer Center-North Campus
Tucson, Arizona 85719
United States
Mercy Hospital Fort Smith
Fort Smith, Arkansas 72903
United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
United States
Kaiser Permanente-Anaheim
Anaheim, California 92806
United States
Kaiser Permanente-Bellflower
Bellflower, California 90706
United States
City of Hope Corona
Corona, California 92882
United States
City of Hope Comprehensive Cancer Center
Duarte, California 91010
United States
UC San Diego Health System - Encinitas
Encinitas, California 92024
United States
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California 92612
United States
City of Hope at Irvine Lennar
Irvine, California 92618
United States
UC San Diego Moores Cancer Center
La Jolla, California 92093
United States
City of Hope Antelope Valley
Lancaster, California 93534
United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California 90027
United States
Cedars-Sinai Medical Center
Los Angeles, California 90048
United States
Providence Queen of The Valley
Napa, California 94558
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
UC San Diego Medical Center - Hillcrest
San Diego, California 92103
United States
Providence Medical Foundation - Santa Rosa
Santa Rosa, California 95403
United States
City of Hope South Pasadena
South Pasadena, California 91030
United States
City of Hope South Bay
Torrance, California 90503
United States
City of Hope Upland
Upland, California 91786
United States
John Muir Medical Center-Walnut Creek
Walnut Creek, California 94598
United States
UCHealth University of Colorado Hospital
Aurora, Colorado 80045
United States
UCHealth Memorial Hospital Central
Colorado Springs, Colorado 80909
United States
Memorial Hospital North
Colorado Springs, Colorado 80920
United States
Poudre Valley Hospital
Fort Collins, Colorado 80524
United States
Cancer Care and Hematology-Fort Collins
Fort Collins, Colorado 80528
United States
UCHealth Greeley Hospital
Greeley, Colorado 80631
United States
Medical Center of the Rockies
Loveland, Colorado 80538
United States
Hartford Hospital
Hartford, Connecticut 06102
United States
The Hospital of Central Connecticut
New Britain, Connecticut 06050
United States
UM Sylvester Comprehensive Cancer Center at Aventura
Aventura, Florida 33180
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
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida 33136
United States
Miami Cancer Institute
Miami, Florida 33176
United States
UM Sylvester Comprehensive Cancer Center at Kendall
Miami, Florida 33176
United States
UM Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida 33324
United States
Moffitt Cancer Center-International Plaza
Tampa, Florida 33607
United States
Moffitt Cancer Center - McKinley Campus
Tampa, Florida 33612
United States
Moffitt Cancer Center
Tampa, Florida 33612
United States
Moffitt Cancer Center at Wesley Chapel
Wesley Chapel, Florida 33544
United States
Emory University Hospital Midtown
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
WellStar Cobb Hospital
Austell, Georgia 30106
United States
Wellstar Kennestone Hospital
Marietta, Georgia 30060
United States
Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu, Hawaii 96813
United States
Queen's Cancer Cenrer - POB I
Honolulu, Hawaii 96813
United States
Queen's Medical Center
Honolulu, Hawaii 96813
United States
University of Hawaii Cancer Center
Honolulu, Hawaii 96813
United States
Queen's Cancer Center - Kuakini
Honolulu, Hawaii 96817
United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii 96826
United States
Castle Medical Center
Kailua, Hawaii 96734
United States
Wilcox Memorial Hospital and Kauai Medical Clinic
Lihue, Hawaii 96766
United States
Hawaii Cancer Care - Westridge
‘Aiea, Hawaii 96701
United States
The Queen's Medical Center - West Oahu
‘Ewa Beach, Hawaii 96706
United States
Centralia Oncology Clinic
Centralia, Illinois 62801
United States
Northwestern University
Chicago, Illinois 60611
United States
Rush MD Anderson Cancer Center
Chicago, Illinois 60612
United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois 60637
United States
Carle at The Riverfront
Danville, Illinois 61832
United States
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois 62526
United States
Decatur Memorial Hospital
Decatur, Illinois 62526
United States
Carle Physician Group-Effingham
Effingham, Illinois 62401
United States
Crossroads Cancer Center
Effingham, Illinois 62401
United States
Elmhurst Memorial Hospital
Elmhurst, Illinois 60126
United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois 61938
United States
Loyola University Medical Center
Maywood, Illinois 60153
United States
Edward Hospital/Cancer Center
Naperville, Illinois 60540
United States
UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois 60451
United States
Cancer Care Center of O'Fallon
O'Fallon, Illinois 62269
United States
HSHS Saint Elizabeth's Hospital
O'Fallon, Illinois 62269
United States
Northwestern Medicine Orland Park
Orland Park, Illinois 60462
United States
University of Chicago Medicine-Orland Park
Orland Park, Illinois 60462
United States
Memorial Hospital East
Shiloh, Illinois 62269
United States
Southern Illinois University School of Medicine
Springfield, Illinois 62702
United States
Springfield Clinic
Springfield, Illinois 62702
United States
Springfield Memorial Hospital
Springfield, Illinois 62781
United States
Carle Cancer Center
Urbana, Illinois 61801
United States
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois 60555
United States
Northwest Cancer Center - Crown Point
Crown Point, Indiana 46307
United States
UChicago Medicine Northwest Indiana
Crown Point, Indiana 46307
United States
Northwest Oncology LLC
Dyer, Indiana 46311
United States
Goshen Center for Cancer Care
Goshen, Indiana 46526
United States
Northwest Cancer Center - Hobart
Hobart, Indiana 46342
United States
Saint Mary Medical Center
Hobart, Indiana 46342
United States
The Community Hospital
Munster, Indiana 46321
United States
Women's Diagnostic Center - Munster
Munster, Indiana 46321
United States
Northwest Cancer Center - Valparaiso
Valparaiso, Indiana 46383
United States
Mary Greeley Medical Center
Ames, Iowa 50010
United States
McFarland Clinic - Ames
Ames, Iowa 50010
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
The University of Kansas Cancer Center - Olathe
Olathe, Kansas 66061
United States
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas 66210
United States
Baptist Health Hardin
Elizabethtown, Kentucky 42701
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
Norton Brownsboro Hospital and Medical Campus
Louisville, Kentucky 40241
United States
UofL Health Medical Center Northeast
Louisville, Kentucky 40245
United States
Owensboro Health Mitchell Memorial Cancer Center
Owensboro, Kentucky 42303
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
Sinai Hospital of Baltimore
Baltimore, Maryland 21215
United States
UM Upper Chesapeake Medical Center
Bel Air, Maryland 21014
United States
Central Maryland Radiation Oncology in Howard County
Columbia, Maryland 21044
United States
University of Maryland Shore Medical Center at Easton
Easton, Maryland 21601
United States
UM Baltimore Washington Medical Center/Tate Cancer Center
Glen Burnie, Maryland 21061
United States
UM Capital Region Medical Center
Largo, Maryland 20774
United States
William E Kahlert Regional Cancer Center/Sinai Hospital
Westminster, Maryland 21157
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
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan 48114
United States
Henry Ford Cancer Institute-Downriver
Brownstown, Michigan 48183
United States
Henry Ford Macomb Hospital-Clinton Township
Clinton Township, Michigan 48038
United States
Henry Ford Hospital
Detroit, Michigan 48202
United States
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan 48154
United States
Henry Ford Health Providence Novi Hospital
Novi, Michigan 48374
United States
MyMichigan Medical Center Saginaw
Saginaw, Michigan 48601
United States
MyMichigan Medical Center Tawas
Tawas City, Michigan 48764
United States
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan 48322
United States
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan 48197
United States
Minnesota Oncology Hematology PA-Chaska
Chaska, Minnesota 55318
United States
Fairview Clinics and Surgery Center Maple Grove
Maple Grove, Minnesota 55369
United States
Hennepin County Medical Center
Minneapolis, Minnesota 55415
United States
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota 55455
United States
Monticello Cancer Center
Monticello, Minnesota 55362
United States
Coborn Cancer Center at Saint Cloud Hospital
Saint Cloud, Minnesota 56303
United States
Ridgeview Medical Center
Waconia, Minnesota 55387
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
Parkland Health Center - Farmington
Farmington, Missouri 63640
United States
Mercy Hospital Springfield
Springfield, Missouri 65804
United States
Washington University School of Medicine
St Louis, Missouri 63110
United States
Siteman Cancer Center-South County
St Louis, Missouri 63129
United States
Siteman Cancer Center at Christian Hospital
St Louis, Missouri 63136
United States
Nebraska Medicine-Bellevue
Bellevue, Nebraska 68123
United States
Nebraska Medicine-Village Pointe
Omaha, Nebraska 68118
United States
University of Nebraska Medical Center
Omaha, Nebraska 68198
United States
Renown Regional Medical Center
Reno, Nevada 89502
United States
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey 07920
United States
Jefferson Cherry Hill Hospital
Cherry Hill, New Jersey 08002
United States
Saint Barnabas Medical Center
Livingston, New Jersey 07039
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
Newark Beth Israel Medical Center
Newark, New Jersey 07112
United States
The Valley Hospital - Luckow Pavilion
Paramus, New Jersey 07652
United States
Valley Health System Ridgewood Campus
Ridgewood, New Jersey 07450
United States
Sidney Kimmel Cancer Center Washington Township
Sewell, New Jersey 08080
United States
Robert Wood Johnson University Hospital Somerset
Somerville, New Jersey 08876
United States
Community Medical Center
Toms River, New Jersey 08755
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
NYU Langone Hospital - Brooklyn
Brooklyn, New York 11220
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
Northwell Health/Center for Advanced Medicine
Lake Success, New York 11042
United States
NYU Langone Hospital - Long Island
Mineola, New York 11501
United States
Mount Sinai Chelsea
New York, New York 10011
United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York 10016
United States
Mount Sinai West
New York, New York 10019
United States
Mount Sinai Hospital
New York, New York 10029
United States
Manhattan Eye Ear and Throat Hospital
New York, New York 10065
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
Lenox Hill Hospital
New York, New York 10075
United States
Mount Sinai South Nassau
Oceanside, New York 11572
United States
University of Rochester
Rochester, New York 14642
United States
Stony Brook University Medical Center
Stony Brook, New York 11794
United States
State University of New York Upstate Medical University
Syracuse, New York 13210
United States
SUNY Upstate Medical Center-Community Campus
Syracuse, New York 13215
United States
Montefiore Medical Center-Einstein Campus
The Bronx, New York 10461
United States
Montefiore Medical Center-Weiler Hospital
The Bronx, New York 10461
United States
Montefiore Medical Center - Moses Campus
The Bronx, New York 10467
United States
Memorial Sloan Kettering Nassau
Uniondale, New York 11553
United States
Sanford Broadway Medical Center
Fargo, North Dakota 58122
United States
Sanford Roger Maris Cancer Center
Fargo, North Dakota 58122
United States
UH Seidman Cancer Center at UH Avon Health Center
Avon, Ohio 44011
United States
Indu and Raj Soin Medical Center
Beavercreek, Ohio 45431
United States
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio 45219
United States
Case Western Reserve University
Cleveland, Ohio 44106
United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
United States
Riverside Methodist Hospital
Columbus, Ohio 43214
United States
Grant Medical Center
Columbus, Ohio 43215
United States
Delaware Health Center-Grady Cancer Center
Delaware, Ohio 43015
United States
Grady Memorial Hospital
Delaware, Ohio 43015
United States
Kettering Medical Center
Kettering, Ohio 45429
United States
UH Seidman Cancer Center at Lake Health Mentor Campus
Mentor, Ohio 44060
United States
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio 45069
United States
Saint Elizabeth Youngstown Hospital
Youngstown, Ohio 44501
United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
United States
Clackamas Radiation Oncology Center
Clackamas, Oregon 97015
United States
Legacy Mount Hood Medical Center
Gresham, Oregon 97030
United States
Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon 97210
United States
Providence Portland Medical Center
Portland, Oregon 97213
United States
Providence Saint Vincent Medical Center
Portland, Oregon 97225
United States
Legacy Meridian Park Hospital
Tualatin, Oregon 97062
United States
Saint Luke's Cancer Center - Allentown
Allentown, Pennsylvania 18104
United States
Saint Luke's University Hospital-Bethlehem Campus
Bethlehem, Pennsylvania 18015
United States
Chambersburg Hospital
Chambersburg, Pennsylvania 17201
United States
Northeast Radiation Oncology Center
Dunmore, Pennsylvania 18512
United States
Saint Luke's Hospital-Anderson Campus
Easton, Pennsylvania 18045
United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania 17033-0850
United States
NRG Oncology
Philadelphia, Pennsylvania 19103
United States
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania 19104
United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107
United States
Jefferson Torresdale Hospital
Philadelphia, Pennsylvania 19114
United States
UPMC-Presbyterian Hospital
Pittsburgh, Pennsylvania 15213
United States
UPMC-Shadyside Hospital
Pittsburgh, Pennsylvania 15232
United States
Saint Luke's Hospital - Upper Bucks Campus
Quakertown, Pennsylvania 18951
United States
Saint Luke's Hospital - Monroe Campus
Stroudsburg, Pennsylvania 18360
United States
Reading Hospital
West Reading, Pennsylvania 19611
United States
WellSpan Health-York Cancer Center
York, Pennsylvania 17403
United States
WellSpan Health-York Hospital
York, Pennsylvania 17403
United States
Saint Francis Hospital
Greenville, South Carolina 29601
United States
Saint Francis Cancer Center
Greenville, South Carolina 29607
United States
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota 57104
United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota 57117-5134
United States
Vanderbilt Breast Center at One Hundred Oaks
Nashville, Tennessee 37204
United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee 37232
United States
MD Anderson in The Woodlands
Conroe, Texas 77384
United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas 77030
United States
Memorial Hermann Texas Medical Center
Houston, Texas 77030
United States
UT MD Anderson Cancer Center
Houston, Texas 77030
United States
MD Anderson West Houston
Houston, Texas 77079
United States
UT MD Anderson - League City
League City, Texas 77573
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas 78229
United States
MD Anderson in Sugar Land
Sugar Land, Texas 77478
United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah 84112
United States
University of Vermont Medical Center
Burlington, Vermont 05401
United States
University of Vermont and State Agricultural College
Burlington, Vermont 05405
United States
University of Virginia Cancer Center
Charlottesville, Virginia 22908
United States
VCU Massey Comprehensive Cancer Center
Richmond, Virginia 23298
United States
Valley Medical Center
Renton, Washington 98055
United States
Legacy Cancer Institute Medical Oncology and Day Treatment
Vancouver, Washington 98684
United States
Legacy Salmon Creek Hospital
Vancouver, Washington 98686
United States
Langlade Hospital and Cancer Center
Antigo, Wisconsin 54409
United States
ThedaCare Regional Cancer Center
Appleton, Wisconsin 54911
United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin 54601
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
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United States
Aspirus Cancer Care - James Beck Cancer Center
Rhinelander, Wisconsin 54501
United States
Aspirus Cancer Care - Stevens Point
Stevens Point, Wisconsin 54481
United States
Aspirus Regional Cancer Center
Wausau, Wisconsin 54401
United States
Aspirus Cancer Care - Wisconsin Rapids
Wisconsin Rapids, Wisconsin 54494
United States
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
Pamela Youde Nethersole Eastern Hospital
Chai Wan,
Hong Kong
Beacon Hospital
Dublin, Co Dublin 18
Ireland
Saint Lukes Hospital
Dublin, Co Dublin 6
Ireland
University College Hospital Galway
Galway, Co Galway
Ireland
Cork Radiation Oncology Associates Limited
Cork,
Ireland
Cork University Hospital
Cork,
Ireland