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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.
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. |
NCT06500455 |
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. |
Rupesh R Kotecha |
Principal Investigator Affiliation | NRG Oncology |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Other |
Overall Status | Recruiting |
Countries | United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma, Metastatic Digestive System Carcinoma, Metastatic Lung Non-Small Cell Carcinoma, Metastatic Malignant Neoplasm in the Brain, Metastatic Malignant Solid Neoplasm, Metastatic Melanoma, Metastatic Renal Cell Carcinoma, Stage IV Lung Cancer AJCC v8, Stage IV Renal Cell Cancer AJCC v8 |
PRIMARY OBJECTIVE:
Active Comparator: ARM I (SRS)
Patients undergo SRS over 30-90 minutes for 1 fraction on study. Additionally, patients undergo CT and MRI on study.
Experimental: ARM II (FSRS)
Patients undergo FSRS over 30-90 minutes for 3 fractions on study. Additionally, patients undergo CT and MRI on study.
Procedure: - Computed Tomography
Undergo CT
Radiation: - Fractionated Stereotactic Radiation Therapy
Undergo FSRS
Procedure: - Magnetic Resonance Imaging
Undergo MRI
Radiation: - Stereotactic Radiosurgery
Undergo SRS
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
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
Kaiser Permanente-Bellflower
Bellflower, California, 90706
Status
Recruiting
Address
City of Hope Corona
Corona, California, 92882
Status
Recruiting
Address
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
Status
Recruiting
Address
UC San Diego Health System - Encinitas
Encinitas, California, 92024
Status
Recruiting
Address
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, 92612
Status
Recruiting
Address
City of Hope at Irvine Lennar
Irvine, California, 92618
Status
Recruiting
Address
UC San Diego Moores Cancer Center
La Jolla, California, 92093
Status
Recruiting
Address
City of Hope Antelope Valley
Lancaster, California, 93534
Status
Recruiting
Address
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027
Status
Recruiting
Address
Providence Queen of The Valley
Napa, California, 94558
Status
Recruiting
Address
Kaiser Permanente-Ontario
Ontario, California, 91761
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
UC San Diego Medical Center - Hillcrest
San Diego, California, 92103
Status
Recruiting
Address
Providence Medical Foundation - Santa Rosa
Santa Rosa, California, 95403
Status
Recruiting
Address
City of Hope South Pasadena
South Pasadena, California, 91030
Status
Recruiting
Address
City of Hope South Bay
Torrance, California, 90503
Status
Recruiting
Address
City of Hope Upland
Upland, California, 91786
Status
Recruiting
Address
Hartford Hospital
Hartford, Connecticut, 06102
Status
Recruiting
Address
The Hospital of Central Connecticut
New Britain, Connecticut, 06050
Status
Recruiting
Address
UM Sylvester Comprehensive Cancer Center at Aventura
Aventura, Florida, 33180
Status
Recruiting
Address
Boca Raton Regional Hospital
Boca Raton, Florida, 33486
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
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
UM Sylvester Comprehensive Cancer Center at Kendall
Miami, Florida, 33176
Status
Recruiting
Address
UM Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida, 33324
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
Piedmont Hospital
Atlanta, Georgia, 30309
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
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526
Status
Recruiting
Address
Decatur Memorial Hospital
Decatur, Illinois, 62526
Status
Recruiting
Address
Crossroads Cancer Center
Effingham, Illinois, 62401
Status
Recruiting
Address
Elmhurst Memorial Hospital
Elmhurst, Illinois, 60126
Status
Recruiting
Address
Loyola University Medical Center
Maywood, Illinois, 60153
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
Recruiting
Address
Cancer Care Center of O'Fallon
O'Fallon, Illinois, 62269
Status
Recruiting
Address
HSHS Saint Elizabeth's Hospital
O'Fallon, Illinois, 62269
Status
Recruiting
Address
University of Chicago Medicine-Orland Park
Orland Park, Illinois, 60462
Status
Recruiting
Address
Memorial Hospital East
Shiloh, Illinois, 62269
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
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, 60555
Status
Recruiting
Address
UChicago Medicine Northwest Indiana
Crown Point, Indiana, 46307
Status
Recruiting
Address
Goshen Center for Cancer Care
Goshen, Indiana, 46526
Status
Recruiting
Address
Mary Greeley Medical Center
Ames, Iowa, 50010
Status
Recruiting
Address
McFarland Clinic - Ames
Ames, Iowa, 50010
Status
Recruiting
Address
University of Kansas Cancer Center
Kansas City, Kansas, 66160
Status
Recruiting
Address
The University of Kansas Cancer Center - Olathe
Olathe, Kansas, 66061
Status
Recruiting
Address
The James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, 40202
Status
Recruiting
Address
Maine Medical Center-Bramhall Campus
Portland, Maine, 04102
Status
Recruiting
Address
MaineHealth Cancer Care Center of York County
Sanford, Maine, 04073
Status
Recruiting
Address
Maine Medical Center- Scarborough Campus
Scarborough, Maine, 04074
Status
Recruiting
Address
Maryland Proton Treatment Center
Baltimore, Maryland, 21201
Status
Recruiting
Address
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201
Status
Recruiting
Address
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
Status
Recruiting
Address
UM Upper Chesapeake Medical Center
Bel Air, Maryland, 21014
Status
Recruiting
Address
Central Maryland Radiation Oncology in Howard County
Columbia, Maryland, 21044
Status
Recruiting
Address
UM Baltimore Washington Medical Center/Tate Cancer Center
Glen Burnie, Maryland, 21061
Status
Recruiting
Address
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, 48106
Status
Recruiting
Address
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
Status
Recruiting
Address
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, 48114
Status
Recruiting
Address
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, 48154
Status
Recruiting
Address
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan, 48197
Status
Recruiting
Address
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, 63141
Status
Recruiting
Address
Parkland Health Center - Farmington
Farmington, Missouri, 63640
Status
Recruiting
Address
Washington University School of Medicine
Saint Louis, Missouri, 63110
Status
Recruiting
Address
Siteman Cancer Center-South County
Saint Louis, Missouri, 63129
Status
Recruiting
Address
Siteman Cancer Center at Christian Hospital
Saint Louis, Missouri, 63136
Status
Recruiting
Address
Siteman Cancer Center at Saint Peters Hospital
Saint Peters, Missouri, 63376
Status
Recruiting
Address
Mercy Hospital Springfield
Springfield, Missouri, 65804
Status
Recruiting
Address
Nebraska Medicine-Bellevue
Bellevue, Nebraska, 68123
Status
Recruiting
Address
Nebraska Medicine-Village Pointe
Omaha, Nebraska, 68118
Status
Recruiting
Address
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Status
Recruiting
Address
Renown Regional Medical Center
Reno, Nevada, 89502
Status
Recruiting
Address
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920
Status
Recruiting
Address
Saint Barnabas Medical Center
Livingston, New Jersey, 07039
Status
Recruiting
Address
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
Status
Recruiting
Address
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645
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
Sidney Kimmel Cancer Center Washington Township
Sewell, New Jersey, 08080
Status
Recruiting
Address
Community Medical Center
Toms River, New Jersey, 08755
Status
Recruiting
Address
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106
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
NYU Langone Hospital - Brooklyn
Brooklyn, New York, 11220
Status
Recruiting
Address
Memorial Sloan Kettering Commack
Commack, New York, 11725
Status
Recruiting
Address
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
Status
Recruiting
Address
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, 10016
Status
Recruiting
Address
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Status
Recruiting
Address
Stony Brook University Medical Center
Stony Brook, New York, 11794
Status
Recruiting
Address
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553
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
Riverside Methodist Hospital
Columbus, Ohio, 43214
Status
Recruiting
Address
Grant Medical Center
Columbus, Ohio, 43215
Status
Recruiting
Address
Kettering Medical Center
Kettering, Ohio, 45429
Status
Recruiting
Address
UH Seidman Cancer Center at Lake Health Mentor Campus
Mentor, Ohio, 44060
Status
Recruiting
Address
Saint Luke's Cancer Center - Allentown
Allentown, Pennsylvania, 18104
Status
Recruiting
Address
Saint Luke's University Hospital-Bethlehem Campus
Bethlehem, Pennsylvania, 18015
Status
Recruiting
Address
Chambersburg Hospital
Chambersburg, Pennsylvania, 17201
Status
Recruiting
Address
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
Status
Recruiting
Address
NRG Oncology
Philadelphia, Pennsylvania, 19103
Status
Recruiting
Address
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Status
Recruiting
Address
Jefferson Torresdale Hospital
Philadelphia, Pennsylvania, 19114
Status
Recruiting
Address
UPMC-Presbyterian Hospital
Pittsburgh, Pennsylvania, 15213
Status
Recruiting
Address
UPMC-Shadyside Hospital
Pittsburgh, Pennsylvania, 15232
Status
Recruiting
Address
Saint Luke's Hospital - Upper Bucks Campus
Quakertown, Pennsylvania, 18951
Status
Recruiting
Address
Reading Hospital
West Reading, Pennsylvania, 19611
Status
Recruiting
Address
WellSpan Health-York Cancer Center
York, Pennsylvania, 17403
Status
Recruiting
Address
WellSpan Health-York Hospital
York, Pennsylvania, 17403
Status
Recruiting
Address
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, 77030
Status
Recruiting
Address
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112
Status
Recruiting
Address
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298
Status
Recruiting
Address
Valley Medical Center
Renton, Washington, 98055
Status
Recruiting
Address
Langlade Hospital and Cancer Center
Antigo, Wisconsin, 54409
Status
Recruiting
Address
ThedaCare Regional Cancer Center
Appleton, Wisconsin, 54911
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
Aspirus Cancer Care - James Beck Cancer Center
Rhinelander, Wisconsin, 54501
Status
Recruiting
Address
Aspirus Cancer Care - Stevens Point
Stevens Point, Wisconsin, 54481
Status
Recruiting
Address
Aspirus Regional Cancer Center
Wausau, Wisconsin, 54401
Status
Recruiting
Address
Aspirus Cancer Care - Wisconsin Rapids
Wisconsin Rapids, Wisconsin, 54494