AzTrials
AzTrials

Anatomic Stage IV Breast Cancer AJCC v8Phase 3NCT06500455

Testing Longer Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients With Cancer That Has Spread to the Brain

A Phase 3 study testing Computed Tomography, Fractionated Stereotactic Radiation Therapy and Magnetic Resonance Imaging in people with Anatomic Stage IV Breast Cancer AJCC v8 and Metastatic Breast Carcinoma, run by NRG Oncology at 270 sites in 4 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Computed Tomography, Fractionated Stereotactic Radiation Therapy and Magnetic Resonance Imaging
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
274 participants
Where
270 sitesin 4 countries
Study dates
12 Dec 2024to 30 Jun 2033
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Pathologically (histologically or cytologically) proven diagnosis of one of the following solid tumor malignancies within 5 years prior to registration:
  • Non-small cell lung cancer
  • Melanoma
  • Breast cancer
  • Renal cell carcinoma
  • Gastrointestinal cancer
Show all 23Show fewer
  • If the original histologic proof of malignancy is greater than 5 years, then more recent pathologic confirmation (e.g., from a systemic site or brain metastasis) or unequivocal imaging confirmation of extracranial metastatic disease (e.g. CT of the chest/abdomen/pelvis, positron emission tomography [PET]/CT, etc.) is required
  • Patients must have at least 1 and up to 8 total intact brain metastases detected on a contrast-enhanced MRI performed ≤ 21 days prior to registration
  • At least 1 of the up to 8 lesions must be a study eligible lesion, defined as lesion with a maximum diameter as measured on any orthogonal plane (axial, sagittal, coronal) of ≥ 1.0 cm and ≤ 3.0 cm
  • All brain metastases must be located outside of the brainstem and ≥ 5 mm from the optic nerves or optic chiasm and ≤ 3.0 cm in maximum dimension
  • Note: brainstem metastases per the MRI within 21 days of registration are an exclusion criterion; however, if the MRI used for treatment planning performed within 7 days of SRS/FSRS reveals a brainstem metastasis, the patient remains eligible if the patient is considered an appropriate radiosurgery candidate per the local investigator
  • Patients must have a diagnosis-specific graded prognostic assessment ≥ 1.5
  • No more than 2 lesions planned for resection if clinically indicated
  • No known leptomeningeal disease (LMD)
  • Note: For the purposes of exclusion, LMD is a clinical diagnosis, defined as positive cerebrospinal fluid (CSF) cytology and/or unequivocal radiologic or clinical evidence of leptomeningeal involvement. Patients with leptomeningeal symptoms in the setting of leptomeningeal enhancement by imaging (MRI) would be considered to have LMD even in the absence of positive CSF cytology. In contrast, an asymptomatic or minimally symptomatic patient with mild or nonspecific leptomeningeal enhancement (MRI) would not be considered to have LMD. In that patient, CSF sampling is not required to formally exclude LMD, but can be performed at the investigator's discretion based on level of clinical suspicion
  • Age ≥ 18 years
  • Karnofsky performance status (KPS) ≥ 60
  • Negative urine or serum pregnancy test (in persons of childbearing potential) within 14 days prior to registration. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal
  • No prior radiotherapy to the brain (partial or whole brain irradiation, SRS, FSRS, or prophylactic cranial irradiation [PCI])
  • New York Heart Association Functional Classification II or better (NYHA Functional Classification III/IV are not eligible) (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification)
  • No active infection currently requiring intravenous (IV) antibiotic management
  • No hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
  • No chronic obstructive pulmonary disease exacerbation or other acute respiratory illness precluding study therapy

Who cannot join

None listed.

Trial locations and contacts

270 sites in 4 countries.

270 sites in 4 countries

United States262 sites

  • Hawaii Cancer Care - Westridge

    ‘Aiea, Hawaii, 96701

  • The Queen's Medical Center - West Oahu

    ‘Ewa Beach, Hawaii, 96706

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87106

  • Saint Luke's Cancer Center - Allentown

    Allentown, Pennsylvania, 18104

  • Mary Greeley Medical Center

    Ames, Iowa, 50010

  • McFarland Clinic - Ames

    Ames, Iowa, 50010

  • Kaiser Permanente-Anaheim

    Anaheim, California, 92806

  • Trinity Health Saint Joseph Mercy Hospital Ann Arbor

    Ann Arbor, Michigan, 48106

  • University of Michigan Rogel Cancer Center

    Ann Arbor, Michigan, 48109

  • Langlade Hospital and Cancer Center

    Antigo, Wisconsin, 54409

  • ThedaCare Regional Cancer Center

    Appleton, Wisconsin, 54911

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

  • Piedmont Hospital

    Atlanta, Georgia, 30309

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Emory Saint Joseph's Hospital

    Atlanta, Georgia, 30342

  • UCHealth University of Colorado Hospital

    Aurora, Colorado, 80045

  • WellStar Cobb Hospital

    Austell, Georgia, 30106

  • UM Sylvester Comprehensive Cancer Center at Aventura

    Aventura, Florida, 33180

  • UH Seidman Cancer Center at UH Avon Health Center

    Avon, Ohio, 44011

  • Maryland Proton Treatment Center

    Baltimore, Maryland, 21201

  • University of Maryland/Greenebaum Cancer Center

    Baltimore, Maryland, 21201

  • Sinai Hospital of Baltimore

    Baltimore, Maryland, 21215

  • Memorial Sloan Kettering Basking Ridge

    Basking Ridge, New Jersey, 07920

  • Indu and Raj Soin Medical Center

    Beavercreek, Ohio, 45431

  • UM Upper Chesapeake Medical Center

    Bel Air, Maryland, 21014

  • Nebraska Medicine-Bellevue

    Bellevue, Nebraska, 68123

  • Kaiser Permanente-Bellflower

    Bellflower, California, 90706

  • Saint Luke's University Hospital-Bethlehem Campus

    Bethlehem, Pennsylvania, 18015

  • Boca Raton Regional Hospital

    Boca Raton, Florida, 33486

  • Trinity Health IHA Medical Group Hematology Oncology - Brighton

    Brighton, Michigan, 48114

  • New York-Presbyterian/Brooklyn Methodist Hospital

    Brooklyn, New York, 11215

  • NYU Langone Hospital - Brooklyn

    Brooklyn, New York, 11220

  • Henry Ford Cancer Institute-Downriver

    Brownstown, Michigan, 48183

  • University of Vermont Medical Center

    Burlington, Vermont, 05401

  • University of Vermont and State Agricultural College

    Burlington, Vermont, 05405

  • Centralia Oncology Clinic

    Centralia, Illinois, 62801

  • Chambersburg Hospital

    Chambersburg, Pennsylvania, 17201

  • University of Virginia Cancer Center

    Charlottesville, Virginia, 22908

  • Minnesota Oncology Hematology PA-Chaska

    Chaska, Minnesota, 55318

  • Jefferson Cherry Hill Hospital

    Cherry Hill, New Jersey, 08002

  • Northwestern University

    Chicago, Illinois, 60611

  • Rush MD Anderson Cancer Center

    Chicago, Illinois, 60612

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637

  • University of Cincinnati Cancer Center-UC Medical Center

    Cincinnati, Ohio, 45219

  • Siteman Cancer Center at Saint Peters Hospital

    City of Saint Peters, Missouri, 63376

  • Clackamas Radiation Oncology Center

    Clackamas, Oregon, 97015

  • Case Western Reserve University

    Cleveland, Ohio, 44106

  • Henry Ford Macomb Hospital-Clinton Township

    Clinton Township, Michigan, 48038

  • UCHealth Memorial Hospital Central

    Colorado Springs, Colorado, 80909

  • Memorial Hospital North

    Colorado Springs, Colorado, 80920

  • Central Maryland Radiation Oncology in Howard County

    Columbia, Maryland, 21044

  • MU Health - University Hospital/Ellis Fischel Cancer Center

    Columbia, Missouri, 65212

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • Grant Medical Center

    Columbus, Ohio, 43215

  • Memorial Sloan Kettering Commack

    Commack, New York, 11725

  • MD Anderson in The Woodlands

    Conroe, Texas, 77384

  • UM Sylvester Comprehensive Cancer Center at Coral Gables

    Coral Gables, Florida, 33146

  • City of Hope Corona

    Corona, California, 92882

  • Siteman Cancer Center at West County Hospital

    Creve Coeur, Missouri, 63141

  • Northwest Cancer Center - Crown Point

    Crown Point, Indiana, 46307

  • UChicago Medicine Northwest Indiana

    Crown Point, Indiana, 46307

  • Carle at The Riverfront

    Danville, Illinois, 61832

  • Cancer Care Specialists of Illinois - Decatur

    Decatur, Illinois, 62526

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • UM Sylvester Comprehensive Cancer Center at Deerfield Beach

    Deerfield Beach, Florida, 33442

  • Delaware Health Center-Grady Cancer Center

    Delaware, Ohio, 43015

  • Grady Memorial Hospital

    Delaware, Ohio, 43015

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • UM Sylvester Comprehensive Cancer Center at Doral

    Doral, Florida, 33166

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

  • Northeast Radiation Oncology Center

    Dunmore, Pennsylvania, 18512

  • Northwest Oncology LLC

    Dyer, Indiana, 46311

  • University of Maryland Shore Medical Center at Easton

    Easton, Maryland, 21601

  • Saint Luke's Hospital-Anderson Campus

    Easton, Pennsylvania, 18045

  • Carle Physician Group-Effingham

    Effingham, Illinois, 62401

  • Crossroads Cancer Center

    Effingham, Illinois, 62401

  • Baptist Health Hardin

    Elizabethtown, Kentucky, 42701

  • Elmhurst Memorial Hospital

    Elmhurst, Illinois, 60126

  • UC San Diego Health System - Encinitas

    Encinitas, California, 92024

  • Sanford Broadway Medical Center

    Fargo, North Dakota, 58122

  • Sanford Roger Maris Cancer Center

    Fargo, North Dakota, 58122

  • Parkland Health Center - Farmington

    Farmington, Missouri, 63640

  • The New York Hospital Medical Center of Queens

    Flushing, New York, 11355

  • Poudre Valley Hospital

    Fort Collins, Colorado, 80524

  • Cancer Care and Hematology-Fort Collins

    Fort Collins, Colorado, 80528

  • Mercy Hospital Fort Smith

    Fort Smith, Arkansas, 72903

  • UM Baltimore Washington Medical Center/Tate Cancer Center

    Glen Burnie, Maryland, 21061

  • Goshen Center for Cancer Care

    Goshen, Indiana, 46526

  • UCHealth Greeley Hospital

    Greeley, Colorado, 80631

  • Saint Francis Hospital

    Greenville, South Carolina, 29601

  • Saint Francis Cancer Center

    Greenville, South Carolina, 29607

  • Legacy Mount Hood Medical Center

    Gresham, Oregon, 97030

  • Memorial Sloan Kettering Westchester

    Harrison, New York, 10604

  • Hartford Hospital

    Hartford, Connecticut, 06102

  • Penn State Milton S Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

  • Northwest Cancer Center - Hobart

    Hobart, Indiana, 46342

  • Saint Mary Medical Center

    Hobart, Indiana, 46342

  • Hawaii Cancer Care Inc - Waterfront Plaza

    Honolulu, Hawaii, 96813

  • Queen's Cancer Cenrer - POB I

    Honolulu, Hawaii, 96813

  • Queen's Medical Center

    Honolulu, Hawaii, 96813

  • University of Hawaii Cancer Center

    Honolulu, Hawaii, 96813

  • Queen's Cancer Center - Kuakini

    Honolulu, Hawaii, 96817

  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii, 96826

  • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

    Houston, Texas, 77030

  • Memorial Hermann Texas Medical Center

    Houston, Texas, 77030

  • UT MD Anderson Cancer Center

    Houston, Texas, 77030

  • MD Anderson West Houston

    Houston, Texas, 77079

  • University of Iowa/Holden Comprehensive Cancer Center

    Iowa City, Iowa, 52242

  • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

    Irvine, California, 92612

  • City of Hope at Irvine Lennar

    Irvine, California, 92618

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • Castle Medical Center

    Kailua, Hawaii, 96734

  • University of Kansas Cancer Center

    Kansas City, Kansas, 66160

  • Kettering Medical Center

    Kettering, Ohio, 45429

  • Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093

  • Northwell Health/Center for Advanced Medicine

    Lake Success, New York, 11042

  • City of Hope Antelope Valley

    Lancaster, California, 93534

  • UM Capital Region Medical Center

    Largo, Maryland, 20774

  • UT MD Anderson - League City

    League City, Texas, 77573

  • University of Kentucky/Markey Cancer Center

    Lexington, Kentucky, 40536

  • Wilcox Memorial Hospital and Kauai Medical Clinic

    Lihue, Hawaii, 96766

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Saint Barnabas Medical Center

    Livingston, New Jersey, 07039

  • Trinity Health Saint Mary Mercy Livonia Hospital

    Livonia, Michigan, 48154

  • Kaiser Permanente Los Angeles Medical Center

    Los Angeles, California, 90027

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • The James Graham Brown Cancer Center at University of Louisville

    Louisville, Kentucky, 40202

  • Norton Brownsboro Hospital and Medical Campus

    Louisville, Kentucky, 40241

  • UofL Health Medical Center Northeast

    Louisville, Kentucky, 40245

  • Medical Center of the Rockies

    Loveland, Colorado, 80538

  • University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

    Madison, Wisconsin, 53718

  • University of Wisconsin Carbone Cancer Center - University Hospital

    Madison, Wisconsin, 53792

  • Fairview Clinics and Surgery Center Maple Grove

    Maple Grove, Minnesota, 55369

  • Wellstar Kennestone Hospital

    Marietta, Georgia, 30060

  • Carle Physician Group-Mattoon/Charleston

    Mattoon, Illinois, 61938

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • UH Seidman Cancer Center at Lake Health Mentor Campus

    Mentor, Ohio, 44060

  • University of Miami Miller School of Medicine-Sylvester Cancer Center

    Miami, Florida, 33136

  • Miami Cancer Institute

    Miami, Florida, 33176

  • UM Sylvester Comprehensive Cancer Center at Kendall

    Miami, Florida, 33176

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jersey, 07748

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • NYU Langone Hospital - Long Island

    Mineola, New York, 11501

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

  • University of Minnesota/Masonic Cancer Center

    Minneapolis, Minnesota, 55455

  • Monticello Cancer Center

    Monticello, Minnesota, 55362

  • Memorial Sloan Kettering Bergen

    Montvale, New Jersey, 07645

  • The Community Hospital

    Munster, Indiana, 46321

  • Women's Diagnostic Center - Munster

    Munster, Indiana, 46321

  • Providence Queen of The Valley

    Napa, California, 94558

  • Edward Hospital/Cancer Center

    Naperville, Illinois, 60540

  • Vanderbilt Breast Center at One Hundred Oaks

    Nashville, Tennessee, 37204

  • Vanderbilt University/Ingram Cancer Center

    Nashville, Tennessee, 37232

  • Jersey Shore Medical Center

    Neptune City, New Jersey, 07753

  • The Hospital of Central Connecticut

    New Britain, Connecticut, 06050

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

  • UC Comprehensive Cancer Center at Silver Cross

    New Lenox, Illinois, 60451

  • Mount Sinai Chelsea

    New York, New York, 10011

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone

    New York, New York, 10016

  • Mount Sinai West

    New York, New York, 10019

  • Mount Sinai Hospital

    New York, New York, 10029

  • Manhattan Eye Ear and Throat Hospital

    New York, New York, 10065

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • NYP/Weill Cornell Medical Center

    New York, New York, 10065

  • Lenox Hill Hospital

    New York, New York, 10075

  • Rutgers New Jersey Medical School

    Newark, New Jersey, 07101

  • Newark Beth Israel Medical Center

    Newark, New Jersey, 07112

  • Henry Ford Health Providence Novi Hospital

    Novi, Michigan, 48374

  • Cancer Care Center of O'Fallon

    O'Fallon, Illinois, 62269

  • HSHS Saint Elizabeth's Hospital

    O'Fallon, Illinois, 62269

  • Mount Sinai South Nassau

    Oceanside, New York, 11572

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • The University of Kansas Cancer Center - Olathe

    Olathe, Kansas, 66061

  • Nebraska Medicine-Village Pointe

    Omaha, Nebraska, 68118

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • Kaiser Permanente-Ontario

    Ontario, California, 91761

  • UC Irvine Health/Chao Family Comprehensive Cancer Center

    Orange, California, 92868

  • Northwestern Medicine Orland Park

    Orland Park, Illinois, 60462

  • University of Chicago Medicine-Orland Park

    Orland Park, Illinois, 60462

  • University of Kansas Cancer Center-Overland Park

    Overland Park, Kansas, 66210

  • Owensboro Health Mitchell Memorial Cancer Center

    Owensboro, Kentucky, 42303

  • Stanford Cancer Institute Palo Alto

    Palo Alto, California, 94304

  • The Valley Hospital - Luckow Pavilion

    Paramus, New Jersey, 07652

  • NRG Oncology

    Philadelphia, Pennsylvania, 19103

  • University of Pennsylvania/Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • Jefferson Torresdale Hospital

    Philadelphia, Pennsylvania, 19114

  • UPMC-Presbyterian Hospital

    Pittsburgh, Pennsylvania, 15213

  • UPMC-Shadyside Hospital

    Pittsburgh, Pennsylvania, 15232

  • UM Sylvester Comprehensive Cancer Center at Plantation

    Plantation, Florida, 33324

  • MaineHealth Maine Medical Center - Portland

    Portland, Maine, 04102

  • Legacy Good Samaritan Hospital and Medical Center

    Portland, Oregon, 97210

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • Providence Saint Vincent Medical Center

    Portland, Oregon, 97225

  • Saint Luke's Hospital - Upper Bucks Campus

    Quakertown, Pennsylvania, 18951

  • Renown Regional Medical Center

    Reno, Nevada, 89502

  • Valley Medical Center

    Renton, Washington, 98055

  • Aspirus Cancer Care - James Beck Cancer Center

    Rhinelander, Wisconsin, 54501

  • VCU Massey Comprehensive Cancer Center

    Richmond, Virginia, 23298

  • Valley Health System Ridgewood Campus

    Ridgewood, New Jersey, 07450

  • University of Rochester

    Rochester, New York, 14642

  • MyMichigan Medical Center Saginaw

    Saginaw, Michigan, 48601

  • Coborn Cancer Center at Saint Cloud Hospital

    Saint Cloud, Minnesota, 56303

  • Huntsman Cancer Institute/University of Utah

    Salt Lake City, Utah, 84112

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229

  • UC San Diego Medical Center - Hillcrest

    San Diego, California, 92103

  • MaineHealth Cancer Care Center of York County

    Sanford, Maine, 04073

  • Providence Medical Foundation - Santa Rosa

    Santa Rosa, California, 95403

  • MaineHealth Maine Medical Center- Scarborough

    Scarborough, Maine, 04074

  • Sidney Kimmel Cancer Center Washington Township

    Sewell, New Jersey, 08080

  • Memorial Hospital East

    Shiloh, Illinois, 62269

  • Sanford Cancer Center Oncology Clinic

    Sioux Falls, South Dakota, 57104

  • Sanford USD Medical Center - Sioux Falls

    Sioux Falls, South Dakota, 57117-5134

  • Robert Wood Johnson University Hospital Somerset

    Somerville, New Jersey, 08876

  • City of Hope South Pasadena

    South Pasadena, California, 91030

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62702

  • Springfield Clinic

    Springfield, Illinois, 62702

  • Springfield Memorial Hospital

    Springfield, Illinois, 62781

  • Mercy Hospital Springfield

    Springfield, Missouri, 65804

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Siteman Cancer Center-South County

    St Louis, Missouri, 63129

  • Siteman Cancer Center at Christian Hospital

    St Louis, Missouri, 63136

  • Aspirus Cancer Care - Stevens Point

    Stevens Point, Wisconsin, 54481

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794

  • Saint Luke's Hospital - Monroe Campus

    Stroudsburg, Pennsylvania, 18360

  • MD Anderson in Sugar Land

    Sugar Land, Texas, 77478

  • State University of New York Upstate Medical University

    Syracuse, New York, 13210

  • SUNY Upstate Medical Center-Community Campus

    Syracuse, New York, 13215

  • Moffitt Cancer Center-International Plaza

    Tampa, Florida, 33607

  • Moffitt Cancer Center - McKinley Campus

    Tampa, Florida, 33612

  • Moffitt Cancer Center

    Tampa, Florida, 33612

  • MyMichigan Medical Center Tawas

    Tawas City, Michigan, 48764

  • Montefiore Medical Center-Einstein Campus

    The Bronx, New York, 10461

  • Montefiore Medical Center-Weiler Hospital

    The Bronx, New York, 10461

  • Montefiore Medical Center - Moses Campus

    The Bronx, New York, 10467

  • Community Medical Center

    Toms River, New Jersey, 08755

  • City of Hope South Bay

    Torrance, California, 90503

  • Legacy Meridian Park Hospital

    Tualatin, Oregon, 97062

  • Banner University Medical Center - Tucson

    Tucson, Arizona, 85719

  • University of Arizona Cancer Center-North Campus

    Tucson, Arizona, 85719

  • Memorial Sloan Kettering Nassau

    Uniondale, New York, 11553

  • City of Hope Upland

    Upland, California, 91786

  • Carle Cancer Center

    Urbana, Illinois, 61801

  • Northwest Cancer Center - Valparaiso

    Valparaiso, Indiana, 46383

  • Legacy Cancer Institute Medical Oncology and Day Treatment

    Vancouver, Washington, 98684

  • Legacy Salmon Creek Hospital

    Vancouver, Washington, 98686

  • Ridgeview Medical Center

    Waconia, Minnesota, 55387

  • John Muir Medical Center-Walnut Creek

    Walnut Creek, California, 94598

  • Northwestern Medicine Cancer Center Warrenville

    Warrenville, Illinois, 60555

  • Aspirus Regional Cancer Center

    Wausau, Wisconsin, 54401

  • Moffitt Cancer Center at Wesley Chapel

    Wesley Chapel, Florida, 33544

  • Henry Ford West Bloomfield Hospital

    West Bloomfield, Michigan, 48322

  • University of Cincinnati Cancer Center-West Chester

    West Chester, Ohio, 45069

  • Reading Hospital

    West Reading, Pennsylvania, 19611

  • William E Kahlert Regional Cancer Center/Sinai Hospital

    Westminster, Maryland, 21157

  • Aspirus Cancer Care - Wisconsin Rapids

    Wisconsin Rapids, Wisconsin, 54494

  • WellSpan Health-York Cancer Center

    York, Pennsylvania, 17403

  • WellSpan Health-York Hospital

    York, Pennsylvania, 17403

  • Saint Elizabeth Youngstown Hospital

    Youngstown, Ohio, 44501

  • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

    Ypsilanti, Michigan, 48197

Other trials in United States

Ireland5 sites

  • Cork Radiation Oncology Associates Limited

    Cork

  • Cork University Hospital

    Cork

  • Beacon Hospital

    Dublin, Co Dublin, 18

  • Saint Lukes Hospital

    Dublin, Co Dublin, 6

  • University College Hospital Galway

    Galway, Co Galway

Other trials in Ireland

Canada2 sites

  • CHUM - Centre Hospitalier de l'Universite de Montreal

    Montreal, Quebec, H2X 3E4

  • The Research Institute of the McGill University Health Centre (MUHC)

    Montreal, Quebec, H3H 2R9

Other trials in Canada

Hong Kong1 site

  • Pamela Youde Nethersole Eastern Hospital

    Chai Wan

Other trials in Hong Kong

About this study

Official title: Phase III Trial of Single Fraction Stereotactic Radiosurgery (SRS) Versus Fractionated SRS (FSRS) for Intact Brain Metastases

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. 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:

  1. 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.

  1. 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.

Being tested
Computed Tomography, Fractionated Stereotactic Radiation Therapy, Magnetic Resonance Imaging, Stereotactic Radiosurgery
Medical subject headings
Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Brain Neoplasms, Neoplasm Metastasis, Melanoma, Carcinoma, Renal Cell, Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT

  • Fractionated Stereotactic Radiation TherapyRadiation

    Also called Fractionated Stereotactic Radiotherapy

    Undergo FSRS

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan

    Undergo MRI

  • Stereotactic RadiosurgeryRadiation

    Also called SRS, Stereotactic External Beam Irradiation, stereotactic external-beam radiation therapy, Stereotactic Radiation Therapy

    Undergo SRS

Study groups in NCT06500455
Study groupRoleWhat they receive
ARM I (SRS)Active comparatorPatients undergo SRS over 30-90 minutes for 1 fraction on study. Additionally, patients undergo CT and MRI on study.
Receives: Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Radiation: Stereotactic Radiosurgery
ARM II (FSRS)ExperimentalPatients undergo FSRS over 30-90 minutes for 3 fractions on study. Additionally, patients undergo CT and MRI on study.
Receives: Procedure: Computed Tomography; Radiation: Fractionated Stereotactic Radiation Therapy; Procedure: Magnetic Resonance Imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to local failure

    The time to local failure will be evaluated at a per-patient level. The cause-specific hazard ratio will be estimated in a Cox proportional hazards (PH) model adjusting for patients and disease characteristics. The Cox PH model will be the principle approach. The cumulative incidence function estimator will also be used to estimate the rate of local failure in the presence of competing event of deaths in the two arms separately. A complementary analysis will involve Gray's test to evaluate the difference in the distribution of local failure between treatment arms. These results will be interpreted in light of the competing deaths.

    Measured: From randomization (with the treatment planning magnetic resonance imaging as the 'baseline' for purposes of disease assessment) to local tumor progression of any study lesion(s), assessed up to 5 years

Secondary outcomes (5)

  1. Intracranial progression-free survival (IPFS)

    IPFS will consist of estimation of its distribution for each treatment arm via the Kaplan-Meier method and a stratified log-rank test. Statistical power will depend on the total IPFS events accumulated at trial end.

    Measured: From the date of randomization until intracranial progression (local or distant intracranial) or death from any cause, whichever occurs first, assessed up to 5 years

  2. Overall survival

    Will consist of estimation of its distribution for each treatment arm via the Kaplan-Meier method and a stratified log-rank test. Reasons for death (e.g. due to neurological cause [any central nervous system event such as an intracranial mass, hemorrhage, or hydrocephalus] or non-neurological cause) will be recorded.

    Measured: From the date of randomization until death from any cause, assessed up to 5 years

  3. Time to radiation necrosis (TTRN)

    The rate of radiation necrosis will be compared in patients who receive fractionated stereotactic radiosurgery to patients who receive stereotactic radiosurgery. The primary comparison of treatment effect on TTRN will be based on testing the cause-specific hazard ratio (CHR) in a univariate Cox proportional hazards model. Additional supplementary analyses will include estimating the cause specific ratio in a Cox proportional hazards model adjusting for patients and disease characteristics (e.g. stratification randomization factors) and estimating the median TTRN via the cumulative incidence function estimator (Korn 1992). The Gray's test will also be used to evaluate the difference in the distribution of TTRN between treatment arms (Gray 1988).

    Measured: From randomization until radiation necrosis, assessed up to 5 years

  4. Time to whole brain radiation therapy (WBRT)

    Analysis of time to WBRT will consist of estimation of its distribution for each treatment arm via the Kaplan-Meier method and a stratified log-rank test. For patients who die prior to WBRT, time to WBRT will be censored at time of death.

    Measured: Up to 5 years

  5. Incidence of adverse events (AEs)

    AEs will be graded according to Common Terminology Criteria in Adverse Events version 5.0. Comprehensive summaries of all AEs by treatment arm will be generated and examined. Counts and frequencies of worst AE per patients will be presented overall and by AE type category, separately by assigned treatment group. The proportion of patients with at least one grade 3 or higher AE will be compared between arms. Frequencies for specific potentially treatment related AEs where grade 3 or higher events are noted may be compared. Any frequencies to be tested will be evaluated using the chi-square or exact test as appropriate, with two-sided significance level of 0.05.

    Measured: Up to 2 years from start of radiation treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2024
  2. Study start12 Dec 2024
  3. Primary completion30 Jun 2028 (estimated)
  4. Study completion30 Jun 2033 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
274 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06500455
Sponsor's protocol ID
NRG-BN013
Other IDs
NCI-2024-04812, NRG-BN013, NRG-BN013, U10CA180868
Status last verified
Sep 2026
First submitted
8 Jul 2024
Last updated
14 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Computed Tomography, Fractionated Stereotactic Radiation Therapy and Magnetic Resonance Imaging in people with Anatomic Stage IV Breast Cancer AJCC v8 and Metastatic Breast Carcinoma, run by NRG Oncology at 270 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 270 sites in United States, Ireland, Canada, Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to local failure (time frame: From randomization (with the treatment planning magnetic resonance imaging as the 'baseline' for purposes of disease assessment) to local tumor progression of any study lesion(s), assessed up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06500455.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.

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