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This phase III trial compares the usual treatment of surgery after stereotactic radiosurgery (SRS) to receiving SRS before surgery in treating patients with cancer that has spread to the brain (brain metastases). Stereotactic radiosurgery is a type of radiation therapy that delivers a high dose of radiation to target tumors and minimizes effect on normal surrounding brain tissue. The combination of surgery and radiation may stop the tumor from growing for a few months or longer and may reduce symptoms of brain metastases. This study investigates whether treating with SRS before surgery may be better than SRS after surgery in reducing the possibility of the tumor coming back, reducing or preventing the cancer from spreading to other areas of the brain and reducing the risk of scarring on the brain from radiation.
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Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
|
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
| Eligible Ages | 18 Years and Over |
| Gender | All |
|
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT05438212 |
|
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 3 |
|
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
NRG Oncology |
|
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Stuart H Burri |
| Principal Investigator Affiliation | NRG Oncology |
|
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Other, NIH |
| Overall Status | Recruiting |
| Countries | Canada, United States |
|
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Metastatic Malignant Neoplasm in the Brain |
PRIMARY OBJECTIVE:
Active Comparator: Arm I (surgery, stereotactic radiosurgery)
Patients undergo surgery per standard of care. Within 10-30 days after surgery, patients undergo stereotactic radiosurgery for 1 fraction.
Experimental: Arm II (stereotactic radiosurgery, surgery)
Within 7 days before surgery, patients undergo stereotactic radiosurgery for 1 fraction. Patients undergo surgery per standard of care.
Procedure: - Brain Surgery
Undergo surgery per standard of care
Other: - Quality-of-Life Assessment
Ancillary studies
Other: - Questionnaire Administration
Ancillary studies
Radiation: - Stereotactic Radiosurgery
Undergo stereotactic radiosurgery
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Recruiting
Address
Saint Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013
Status
Recruiting
Address
Banner University Medical Center - Tucson
Tucson, Arizona, 85719
Status
Recruiting
Address
University of Arizona Cancer Center-North Campus
Tucson, Arizona, 85719
Status
Recruiting
Address
Kaiser Permanente-Anaheim
Anaheim, California, 92806
Status
Recruiting
Address
Sutter Auburn Faith Hospital
Auburn, California, 95602
Status
Recruiting
Address
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn, California, 95603
Status
Recruiting
Address
Kaiser Permanente-Bellflower
Bellflower, California, 90706
Status
Recruiting
Address
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, 92612
Status
Recruiting
Address
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027
Status
Recruiting
Address
Memorial Medical Center
Modesto, California, 95355
Status
Recruiting
Address
Kaiser Permanente-Ontario
Ontario, California, 91761
Status
Recruiting
Address
Saint Joseph Hospital - Orange
Orange, California, 92868
Status
Recruiting
Address
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, 92868
Status
Recruiting
Address
Stanford Cancer Institute Palo Alto
Palo Alto, California, 94304
Status
Recruiting
Address
Sutter Cancer Centers Radiation Oncology Services-Roseville
Roseville, California, 95661
Status
Recruiting
Address
Sutter Roseville Medical Center
Roseville, California, 95661
Status
Recruiting
Address
Sutter Medical Center Sacramento
Sacramento, California, 95816
Status
Recruiting
Address
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817
Status
Suspended
Address
California Pacific Medical Center-Pacific Campus
San Francisco, California, 94115
Status
Recruiting
Address
UCSF Medical Center-Parnassus
San Francisco, California, 94143
Status
Recruiting
Address
Sutter Pacific Medical Foundation
Santa Rosa, California, 95403
Status
Recruiting
Address
Sutter Solano Medical Center/Cancer Center
Vallejo, California, 94589
Status
Recruiting
Address
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida, 33146
Status
Recruiting
Address
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, 33442
Status
Recruiting
Address
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
Status
Recruiting
Address
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136
Status
Recruiting
Address
Miami Cancer Institute
Miami, Florida, 33176
Status
Recruiting
Address
Moffitt Cancer Center-International Plaza
Tampa, Florida, 33607
Status
Recruiting
Address
Moffitt Cancer Center - McKinley Campus
Tampa, Florida, 33612
Status
Recruiting
Address
Moffitt Cancer Center
Tampa, Florida, 33612
Status
Recruiting
Address
Moffitt Cancer Center at Wesley Chapel
Wesley Chapel, Florida, 33544
Status
Recruiting
Address
Grady Health System
Atlanta, Georgia, 30303
Status
Recruiting
Address
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Status
Recruiting
Address
Piedmont Hospital
Atlanta, Georgia, 30309
Status
Recruiting
Address
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
Status
Recruiting
Address
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342
Status
Recruiting
Address
Advocate Outpatient Center - Aurora
Aurora, Illinois, 60506
Status
Recruiting
Address
Advocate Good Shepherd Hospital
Barrington, Illinois, 60010
Status
Recruiting
Address
Centralia Oncology Clinic
Centralia, Illinois, 62801
Status
Recruiting
Address
Northwestern University
Chicago, Illinois, 60611
Status
Recruiting
Address
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637
Status
Recruiting
Address
AMG Crystal Lake - Oncology
Crystal Lake, Illinois, 60014
Status
Recruiting
Address
Carle at The Riverfront
Danville, Illinois, 61832
Status
Recruiting
Address
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526
Status
Recruiting
Address
Decatur Memorial Hospital
Decatur, Illinois, 62526
Status
Recruiting
Address
Advocate Good Samaritan Hospital
Downers Grove, Illinois, 60515
Status
Recruiting
Address
Carle Physician Group-Effingham
Effingham, Illinois, 62401
Status
Recruiting
Address
Crossroads Cancer Center
Effingham, Illinois, 62401
Status
Recruiting
Address
Elmhurst Memorial Hospital
Elmhurst, Illinois, 60126
Status
Recruiting
Address
Advocate South Suburban Hospital
Hazel Crest, Illinois, 60429
Status
Recruiting
Address
AMG Libertyville - Oncology
Libertyville, Illinois, 60048
Status
Recruiting
Address
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938
Status
Recruiting
Address
Edward Hospital/Cancer Center
Naperville, Illinois, 60540
Status
Recruiting
Address
UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois, 60451
Status
Suspended
Address
Cancer Care Center of O'Fallon
O'Fallon, Illinois, 62269
Status
Recruiting
Address
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453-2699
Status
Recruiting
Address
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068
Status
Recruiting
Address
Southern Illinois University School of Medicine
Springfield, Illinois, 62702
Status
Recruiting
Address
Springfield Clinic
Springfield, Illinois, 62702
Status
Recruiting
Address
Springfield Memorial Hospital
Springfield, Illinois, 62781
Status
Recruiting
Address
Carle Cancer Center
Urbana, Illinois, 61801
Status
Recruiting
Address
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, 60555
Status
Recruiting
Address
Ascension Saint Vincent Indianapolis Hospital
Indianapolis, Indiana, 46260
Status
Recruiting
Address
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa, 50023
Status
Recruiting
Address
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa, 50325
Status
Recruiting
Address
Iowa Methodist Medical Center
Des Moines, Iowa, 50309
Status
Recruiting
Address
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa, 50309
Status
Recruiting
Address
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa, 50314
Status
Recruiting
Address
UI Health Care Mission Cancer and Blood - Waukee Clinic
Waukee, Iowa, 50263
Status
Recruiting
Address
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201
Status
Recruiting
Address
UM Baltimore Washington Medical Center/Tate Cancer Center
Glen Burnie, Maryland, 21061
Status
Recruiting
Address
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
Status
Not yet recruiting
Address
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201
Status
Active, not recruiting
Address
Weisberg Cancer Treatment Center
Farmington Hills, Michigan, 48334
Status
Recruiting
Address
Corewell Health William Beaumont University Hospital
Royal Oak, Michigan, 48073
Status
Recruiting
Address
Corewell Health Beaumont Troy Hospital
Troy, Michigan, 48085
Status
Recruiting
Address
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, 56401
Status
Recruiting
Address
Essentia Health - Deer River Clinic
Deer River, Minnesota, 56636
Status
Recruiting
Address
Essentia Health Cancer Center
Duluth, Minnesota, 55805
Status
Recruiting
Address
Essentia Health Saint Mary's Medical Center
Duluth, Minnesota, 55805
Status
Recruiting
Address
Miller-Dwan Hospital
Duluth, Minnesota, 55805
Status
Recruiting
Address
Essentia Health Hibbing Clinic
Hibbing, Minnesota, 55746
Status
Recruiting
Address
Coborn Cancer Center at Saint Cloud Hospital
Saint Cloud, Minnesota, 56303
Status
Recruiting
Address
Essentia Health Sandstone
Sandstone, Minnesota, 55072
Status
Recruiting
Address
Essentia Health Virginia Clinic
Virginia, Minnesota, 55792
Status
Recruiting
Address
Parkland Health Center - Farmington
Farmington, Missouri, 63640
Status
Recruiting
Address
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
Status
Recruiting
Address
Missouri Baptist Medical Center
Saint Louis, Missouri, 63131
Status
Recruiting
Address
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri, 63670
Status
Recruiting
Address
Mercy Hospital Springfield
Springfield, Missouri, 65804
Status
Recruiting
Address
Missouri Baptist Sullivan Hospital
Sullivan, Missouri, 63080
Status
Recruiting
Address
BJC Outpatient Center at Sunset Hills
Sunset Hills, Missouri, 63127
Status
Recruiting
Address
Billings Clinic Cancer Center
Billings, Montana, 59101
Status
Recruiting
Address
Benefis Sletten Cancer Institute
Great Falls, Montana, 59405
Status
Recruiting
Address
Renown Regional Medical Center
Reno, Nevada, 89502
Status
Recruiting
Address
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, 03756
Status
Recruiting
Address
Cooper Hospital University Medical Center
Camden, New Jersey, 08103
Status
Recruiting
Address
Saint Barnabas Medical Center
Livingston, New Jersey, 07039
Status
Recruiting
Address
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
Status
Recruiting
Address
Newark Beth Israel Medical Center
Newark, New Jersey, 07112
Status
Recruiting
Address
The Valley Hospital - Luckow Pavilion
Paramus, New Jersey, 07652
Status
Recruiting
Address
Capital Health Medical Center-Hopewell
Pennington, New Jersey, 08534
Status
Recruiting
Address
Valley Health System Ridgewood Campus
Ridgewood, New Jersey, 07450
Status
Recruiting
Address
Community Medical Center
Toms River, New Jersey, 08755
Status
Recruiting
Address
Valley Health System-Hematology/Oncology
Westwood, New Jersey, 07675
Status
Recruiting
Address
Montefiore Medical Center-Einstein Campus
Bronx, New York, 10461
Status
Recruiting
Address
Montefiore Medical Center-Weiler Hospital
Bronx, New York, 10461
Status
Recruiting
Address
Montefiore Medical Center - Moses Campus
Bronx, New York, 10467
Status
Recruiting
Address
New York-Presbyterian/Brooklyn Methodist Hospital
Brooklyn, New York, 11215
Status
Active, not recruiting
Address
Roswell Park Cancer Institute
Buffalo, New York, 14263
Status
Suspended
Address
The New York Hospital Medical Center of Queens
Flushing, New York, 11355
Status
Recruiting
Address
Northern Westchester Hospital
Mount Kisco, New York, 10549
Status
Suspended
Address
Mount Sinai Chelsea
New York, New York, 10011
Status
Suspended
Address
Mount Sinai West
New York, New York, 10019
Status
Suspended
Address
Mount Sinai Hospital
New York, New York, 10029
Status
Active, not recruiting
Address
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
Status
Recruiting
Address
Manhattan Eye Ear and Throat Hospital
New York, New York, 10065
Status
Recruiting
Address
NYP/Weill Cornell Medical Center
New York, New York, 10065
Status
Recruiting
Address
Lenox Hill Hospital
New York, New York, 10075
Status
Recruiting
Address
University of Rochester
Rochester, New York, 14642
Status
Recruiting
Address
Stony Brook University Medical Center
Stony Brook, New York, 11794
Status
Recruiting
Address
Good Samaritan University Hospital
West Islip, New York, 11795
Status
Recruiting
Address
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, 28203
Status
Recruiting
Address
Atrium Health Cabarrus/LCI-Concord
Concord, North Carolina, 28025
Status
Recruiting
Address
CaroMont Regional Medical Center
Gastonia, North Carolina, 28054
Status
Recruiting
Address
Novant Health Cancer Institute Radiation Oncology - Wilmington
Wilmington, North Carolina, 28401
Status
Recruiting
Address
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
Status
Recruiting
Address
Sanford Broadway Medical Center
Fargo, North Dakota, 58122
Status
Recruiting
Address
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122
Status
Recruiting
Address
Indu and Raj Soin Medical Center
Beavercreek, Ohio, 45431
Status
Recruiting
Address
Case Western Reserve University
Cleveland, Ohio, 44106
Status
Recruiting
Address
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Status
Recruiting
Address
Riverside Methodist Hospital
Columbus, Ohio, 43214
Status
Recruiting
Address
Grant Medical Center
Columbus, Ohio, 43215
Status
Recruiting
Address
Delaware Health Center-Grady Cancer Center
Delaware, Ohio, 43015
Status
Recruiting
Address
Grady Memorial Hospital
Delaware, Ohio, 43015
Status
Recruiting
Address
Kettering Medical Center
Kettering, Ohio, 45429
Status
Recruiting
Address
Mercy Health - Perrysburg Hospital
Perrysburg, Ohio, 43551
Status
Recruiting
Address
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Status
Recruiting
Address
Northeast Radiation Oncology Center
Dunmore, Pennsylvania, 18512
Status
Recruiting
Address
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
Status
Suspended
Address
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Status
Recruiting
Address
UPMC-Presbyterian Hospital
Pittsburgh, Pennsylvania, 15213
Status
Recruiting
Address
UPMC-Shadyside Hospital
Pittsburgh, Pennsylvania, 15232
Status
Recruiting
Address
Medical University of South Carolina
Charleston, South Carolina, 29425
Status
Recruiting
Address
Gibbs Cancer Center-Gaffney
Gaffney, South Carolina, 29341
Status
Recruiting
Address
Gibbs Cancer Center-Pelham
Greer, South Carolina, 29651
Status
Recruiting
Address
Spartanburg Medical Center
Spartanburg, South Carolina, 29303
Status
Recruiting
Address
SMC Center for Hematology Oncology Union
Union, South Carolina, 29379
Status
Recruiting
Address
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, 57104
Status
Recruiting
Address
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134
Status
Recruiting
Address
The Children's Hospital at TriStar Centennial
Nashville, Tennessee, 37203
Status
Suspended
Address
Covenant Medical Center-Lakeside
Lubbock, Texas, 79410
Status
Completed
Address
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
Status
Active, not recruiting
Address
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112
Status
Recruiting
Address
Inova Schar Cancer Institute
Fairfax, Virginia, 22031
Status
Recruiting
Address
Henrico Doctor's Hospital
Richmond, Virginia, 23229
Status
Recruiting
Address
CJW Medical Center - Johnston-Willis Campus
Richmond, Virginia, 23235
Status
Recruiting
Address
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298
Status
Recruiting
Address
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, 24033
Status
Recruiting
Address
ThedaCare Regional Cancer Center
Appleton, Wisconsin, 54911
Status
Recruiting
Address
Duluth Clinic Ashland
Ashland, Wisconsin, 54806
Status
Recruiting
Address
Northwest Wisconsin Cancer Center
Ashland, Wisconsin, 54806
Status
Recruiting
Address
Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin, 53105
Status
Recruiting
Address
Aurora Health Care Germantown Health Center
Germantown, Wisconsin, 53022
Status
Recruiting
Address
Aurora Cancer Care-Grafton
Grafton, Wisconsin, 53024
Status
Recruiting
Address
Aurora BayCare Medical Center
Green Bay, Wisconsin, 54311
Status
Recruiting
Address
Essentia Health-Hayward Clinic
Hayward, Wisconsin, 54843
Status
Recruiting
Address
Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin, 53142
Status
Recruiting
Address
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Madison, Wisconsin, 53718
Status
Recruiting
Address
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, 53792
Status
Recruiting
Address
Aurora Cancer Care-Milwaukee
Milwaukee, Wisconsin, 53209
Status
Recruiting
Address
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, 53215
Status
Recruiting
Address
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Status
Recruiting
Address
Aurora Sinai Medical Center
Milwaukee, Wisconsin, 53233
Status
Recruiting
Address
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin, 54904
Status
Recruiting
Address
Aurora Cancer Care-Racine
Racine, Wisconsin, 53406
Status
Recruiting
Address
Aspirus Cancer Care - James Beck Cancer Center
Rhinelander, Wisconsin, 54501
Status
Recruiting
Address
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin, 53081
Status
Recruiting
Address
Essentia Health-Spooner Clinic
Spooner, Wisconsin, 54801
Status
Recruiting
Address
Aspirus Cancer Care - Stevens Point
Stevens Point, Wisconsin, 54481
Status
Recruiting
Address
Aurora Medical Center in Summit
Summit, Wisconsin, 53066
Status
Recruiting
Address
Essentia Health Saint Mary's Hospital - Superior
Superior, Wisconsin, 54880
Status
Suspended
Address
UW Cancer Center at ProHealth Care
Waukesha, Wisconsin, 53188
Status
Recruiting
Address
Aspirus Regional Cancer Center
Wausau, Wisconsin, 54401
Status
Recruiting
Address
Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin, 53226
Status
Recruiting
Address
Aurora West Allis Medical Center
West Allis, Wisconsin, 53227
Status
Recruiting
Address
Aspirus Cancer Care - Wisconsin Rapids
Wisconsin Rapids, Wisconsin, 54494
Status
Suspended
Address
CHUM - Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2X 3E4
Status
Suspended
Address
The Research Institute of the McGill University Health Centre (MUHC)
Montreal, Quebec, H3H 2R9
Status
Suspended
Address
CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)
Quebec City, Quebec, G1R 2J6
