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Active, not recruitingPhase 3

Single Fraction Stereotactic Radiosurgery or Three to Five Fraction Stereotactic Radiosurgery in Treating Patients With Brain Metastasis That Has Been Removed by Surgery

Key facts

Who runs it
Alliance for Clinical Trials in Oncology
Where
Albuquerque, Ames, Anaconda, Anchorage, Ann Arbor, Ashland, Atlanta, Aurora, Baker City, Ballwin, Baltimore, Baton Rouge, Bay City, Bemidji, Billings, Birmingham, Bismarck, Bloomington, Boca Raton, Boise, Bonne Terre, Boone, Bozeman, Branson, Brighton, Brookfield, Burnsville, Caldwell, Cambridge, Canton, Cape Girardeau, Carbondale, Carterville, Carthage, Centralia, Charlotte, Charlottesville, Chelsea, Chicago, Cincinnati, Clearwater, Cody, Coeur d'Alene, Colorado Springs, Columbus, Coon Rapids, Coral Gables, Dallas, Decatur, Deerfield Beach, Detroit, Dixon, Duluth, Dunmore, Edina, Effingham, Emmett, Eureka, Evanston, Fairfax, Fargo, Farmington, Flint, Fort Dodge, Fort Smith, Franklin, Fridley, Furlong, Galesburg, Gilbert, Glandale, Glens Falls, Grand Rapids, Great Falls, Green Bay, Greenville, Greer, Houston, Iowa City, Jackson, Jacksonville, Jefferson, Jefferson City, Jonesboro, Joplin, Kalispell, Kansas City, Kewanee, La Crosse, La Jolla, Lansing, Lee's Summit, Lexington, Livingston, Livonia, Los Angeles, Macomb, Madison, Maple Grove, Maplewood, Marshalltown, Memphis, Meridian, Miami, Milwaukee, Minneapolis, Missoula, Monticello, Mount Clemens, Mount Vernon, Nampa, New Brunswick, New Haven, New Richmond, New Ulm, New York, Newark, North Kansas City, Novi, O'Fallon, Oklahoma City, Oneida, Ontario, Ottawa, Overland Park, Pekin, Peoria, Peru, Petoskey, Philadelphia, Phoenix, Port Huron, Portland, Post Falls, Princeton, Racine, Rehoboth Beach, Richmond, Robbinsdale, Rochester, Rolla, Saginaw, Saint Cloud, Saint Joseph, Saint Louis Park, Saint Paul, Sainte Genevieve, Salt Lake City, Sandpoint, Sayre, Scarborough, Scottsdale, Shakopee, Sheridan, Sioux Falls, Springfield, St Louis, Stillwater, Stony Brook, Sullivan, Sunset Hills, Swansea, Syracuse, Tampa, Toms River, Tucson, Urbana, Waconia, Walnut Creek, Washington, Waukesha, Wausau, West Chester, West Columbia, Westwood, Willmar, Winston-Salem, Woodbury, and Wyoming, United StatesSee the 223 sitesAlso in 1 other country, 9 sites
Trial code
Status
Active, not recruiting
Phase
Phase 3
People taking part
242 people enrolled
Started
19 Nov 2019
Expected to end
Sept 2028
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Single Fraction Stereotactic Radiosurgery
  • Fractionated Stereotactic Radiosurgery
  • Quality-of-Life Assessment
  • Questionnaire Administration
Record updated
17 September 2026

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 17 criteriaShow less

Who can take part

  • PRE-REGISTRATION:
  • Pathology from the resected brain metastasis must be consistent with a non-central nervous system primary site. Patients with or without active disease outside the nervous system are eligible (including patients with unknown primaries), as long as the pathology from the brain is consistent with a non-central nervous system primary site
  • Three or fewer (i.e. 0 to 3) unresected brain metastases (as defined on the post operative magnetic resonance imaging [MRI]) at the time of screening; o Note: Dural based metastases (e.g. commonly seen in breast cancer) are eligible
  • Unresected lesions must measure < 4.0 cm in maximal extent on the contrasted post-operative treatment MRI brain scan. The unresected lesions will be treated with SRS as outlined in the treatment section of the concept; o Note: The metastases size restriction does not apply to the resected brain metastasis
  • One brain metastasis must be completely (gross total resection) resected =< 30 days prior to pre-registration; o NOTE: May not have had resection of more than one brain metastasis
  • The resected brain metastasis must measure 2 cm or larger on the pre-operative MRI
  • Resection cavity must measure < 5.0 cm in maximal extent and the resection must be complete (gross total resection) on the post-operative MRI obtained =< 30 days prior to pre-registration
  • Karnofsky performance status of >= 60
  • For women of childbearing potential only, a negative urine or serum pregnancy test done =< 7 days prior to pre-registration is required; Men and women of childbearing potential must be willing to employ adequate contraception throughout the study and for men for up to 3 months after completing treatment; A female of childbearing potential is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
  • Ability to complete an MRI of the head with contrast
  • The brain metastasis must be located > 5 mm of the optic chiasm; the brain metastasis must be located outside the brainstem (i.e. not inside the brainstem)
  • Must not have any prior whole brain radiation therapy
  • Past radiosurgery to other lesions is allowed; o NOTE: The surgically resected lesion cannot be the same location treated in the past with radiosurgery (i.e. repeat radiosurgery to the same location/lesion is not allowed on this protocol)
  • May not have primary germ cell tumor, small cell carcinoma, or lymphoma
  • No evidence of leptomeningeal metastasis (LMD); o NOTE: For the purposes of exclusion, LMD is a clinical diagnosis, defined as positive cerebrospinal fluid (CSF) cytology and/or equivocal 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, unless a parenchymal lesion can adequately explain the neurologic symptoms and/or signs. 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
  • Must be fluent in English, Spanish, or French; REGISTRATION:
  • Completion of all baseline electronic patient-reported outcome (ePRO) quality of life measures (or booklet quality of life measures) and Montreal Cognitive Assessment (MoCA)

Where in United States

Also in 1 other country, 9 sites

  • University of New Mexico Cancer CenterAlbuquerque, United States
  • Mary Greeley Medical CenterAmes, United States
  • McFarland Clinic - AmesAmes, United States
  • Community Hospital of AnacondaAnaconda, United States
  • Anchorage Radiation Therapy CenterAnchorage, United States
  • Saint Joseph Mercy HospitalAnn Arbor, United States
  • University Of Michigan Comprehensive Cancer CenterAnn Arbor, United States
  • Northwest Wisconsin Cancer CenterAshland, United States
  • Emory Saint Joseph's HospitalAtlanta, United States
  • Emory University Hospital MidtownAtlanta, United States
  • Emory University Hospital/Winship Cancer InstituteAtlanta, United States
  • University of Colorado HospitalAurora, United States
  • Saint Alphonsus Medical Center-Baker CityBaker City, United States
  • Saint Louis Cancer and Breast Institute-BallwinBallwin, United States
  • MedStar Franklin Square Medical Center/Weinberg Cancer InstituteBaltimore, United States
  • Mary Bird Perkins Cancer CenterBaton Rouge, United States
  • Woman's HospitalBaton Rouge, United States
  • McLaren Cancer Institute-Bay CityBay City, United States
  • Sanford Joe Lueken Cancer CenterBemidji, United States
  • Billings Clinic Cancer CenterBillings, United States
  • University of Alabama at Birmingham Cancer CenterBirmingham, United States
  • Sanford Bismarck Medical CenterBismarck, United States
  • Illinois CancerCare-BloomingtonBloomington, United States
  • Boca Raton Regional HospitalBoca Raton, United States
  • Saint Alphonsus Cancer Care Center-BoiseBoise, United States
  • Parkland Health Center-Bonne TerreBonne Terre, United States
  • McFarland Clinic - BooneBoone, United States
  • Bozeman Deaconess HospitalBozeman, United States
  • Cox Cancer Center BransonBranson, United States
  • Saint Joseph Mercy BrightonBrighton, United States
  • Ascension Southeast Wisconsin Hospital - Elmbrook CampusBrookfield, United States
  • Fairview Ridges HospitalBurnsville, United States
  • Saint Alphonsus Cancer Care Center-CaldwellCaldwell, United States
  • Cambridge Medical CenterCambridge, United States
  • Illinois CancerCare-CantonCanton, United States
  • Saint Joseph Mercy CantonCanton, United States
  • Saint Francis Medical CenterCape Girardeau, United States
  • Southeast Cancer CenterCape Girardeau, United States
  • Memorial Hospital of CarbondaleCarbondale, United States
  • SIH Cancer InstituteCarterville, United States
  • Illinois CancerCare-CarthageCarthage, United States
  • Centralia Oncology ClinicCentralia, United States
  • Novant Health Presbyterian Medical CenterCharlotte, United States
  • University of Virginia Cancer CenterCharlottesville, United States
  • Saint Joseph Mercy ChelseaChelsea, United States
  • Northwestern UniversityChicago, United States
  • University of Cincinnati Cancer Center-UC Medical CenterCincinnati, United States
  • Morton Plant HospitalClearwater, United States
  • Billings Clinic-CodyCody, United States
  • Kootenai Health - Coeur d'AleneCoeur d'Alene, United States
  • UCHealth Memorial Hospital CentralColorado Springs, United States
  • Ohio State University Comprehensive Cancer CenterColumbus, United States
  • Mercy HospitalCoon Rapids, United States
  • UM Sylvester Comprehensive Cancer Center at Coral GablesCoral Gables, United States
  • UT Southwestern/Simmons Cancer Center-DallasDallas, United States
  • Cancer Care Specialists of Illinois - DecaturDecatur, United States
  • Decatur Memorial HospitalDecatur, United States
  • UM Sylvester Comprehensive Cancer Center at Deerfield BeachDeerfield Beach, United States
  • Wayne State University/Karmanos Cancer InstituteDetroit, United States
  • Illinois CancerCare-DixonDixon, United States
  • Miller-Dwan HospitalDuluth, United States
  • Northeast Radiation Oncology CenterDunmore, United States
  • Fairview Southdale HospitalEdina, United States
  • Crossroads Cancer CenterEffingham, United States
  • Walter Knox Memorial HospitalEmmett, United States
  • Illinois CancerCare-EurekaEureka, United States
  • NorthShore University HealthSystem-Evanston HospitalEvanston, United States
  • Inova Schar Cancer InstituteFairfax, United States
  • Sanford Roger Maris Cancer CenterFargo, United States
  • Parkland Health Center - FarmingtonFarmington, United States
  • McLaren Cancer Institute-FlintFlint, United States
  • McFarland Clinic - Trinity Cancer CenterFort Dodge, United States
  • Mercy Hospital Fort SmithFort Smith, United States
  • Ascension Saint Francis - Reiman Cancer CenterFranklin, United States
  • Unity HospitalFridley, United States
  • Fox Chase Cancer Center BuckinghamFurlong, United States
  • Illinois CancerCare-GalesburgGalesburg, United States
  • Western Illinois Cancer Treatment CenterGalesburg, United States
  • Banner MD Anderson Cancer CenterGilbert, United States
  • Banner Thunderbird Medical CenterGlandale, United States
  • Glens Falls HospitalGlens Falls, United States
  • Spectrum Health at Butterworth CampusGrand Rapids, United States
  • Benefis Healthcare- Sletten Cancer InstituteGreat Falls, United States
  • Great Falls ClinicGreat Falls, United States
  • Aurora BayCare Medical CenterGreen Bay, United States
  • Saint Francis Cancer CenterGreenville, United States
  • Gibbs Cancer Center-PelhamGreer, United States
  • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer CenterHouston, United States
  • M D Anderson Cancer CenterHouston, United States
  • Memorial Hermann Texas Medical CenterHouston, United States
  • University of Iowa/Holden Comprehensive Cancer CenterIowa City, United States
  • University of Mississippi Medical CenterJackson, United States
  • Mayo Clinic in FloridaJacksonville, United States
  • McFarland Clinic - JeffersonJefferson, United States
  • Capital Region Southwest CampusJefferson City, United States
  • NEA Baptist Memorial Hospital and Fowler Family Cancer Center - JonesboroJonesboro, United States
  • Freeman Health SystemJoplin, United States
  • Mercy Hospital JoplinJoplin, United States
  • Kalispell Regional Medical CenterKalispell, United States
  • University of Kansas Cancer CenterKansas City, United States
  • Illinois CancerCare-Kewanee ClinicKewanee, United States
  • Gundersen Lutheran Medical CenterLa Crosse, United States
  • UC San Diego Moores Cancer CenterLa Jolla, United States
  • Karmanos Cancer Institute at McLaren Greater LansingLansing, United States
  • University of Kansas Cancer Center - Lee's SummitLee's Summit, United States
  • University of Kentucky/Markey Cancer CenterLexington, United States
  • Saint Barnabas Medical CenterLivingston, United States
  • Trinity Health Saint Mary Mercy Livonia HospitalLivonia, United States
  • Los Angeles County-USC Medical CenterLos Angeles, United States
  • USC / Norris Comprehensive Cancer CenterLos Angeles, United States
  • Illinois CancerCare-MacombMacomb, United States
  • University of Wisconsin Carbone Cancer CenterMadison, United States
  • Fairview Clinics and Surgery Center Maple GroveMaple Grove, United States
  • Minnesota Oncology Hematology PA-MaplewoodMaplewood, United States
  • Saint John's Hospital - HealtheastMaplewood, United States
  • McFarland Clinic - MarshalltownMarshalltown, United States
  • Baptist Memorial Hospital and Cancer Center-MemphisMemphis, United States
  • Idaho Urologic Institute-MeridianMeridian, United States
  • University of Miami Miller School of Medicine-Sylvester Cancer CenterMiami, United States
  • Ascension Columbia Saint Mary's Hospital - MilwaukeeMilwaukee, United States
  • Aurora Saint Luke's Medical CenterMilwaukee, United States
  • Medical College of WisconsinMilwaukee, United States
  • Abbott-Northwestern HospitalMinneapolis, United States
  • Health Partners IncMinneapolis, United States
  • Hennepin County Medical CenterMinneapolis, United States
  • Community Medical HospitalMissoula, United States
  • Monticello Cancer CenterMonticello, United States
  • McLaren Cancer Institute-MacombMount Clemens, United States
  • Good Samaritan Regional Health CenterMount Vernon, United States
  • Saint Alphonsus Cancer Care Center-NampaNampa, United States
  • Rutgers Cancer Institute of New JerseyNew Brunswick, United States
  • Yale UniversityNew Haven, United States
  • Cancer Center of Western WisconsinNew Richmond, United States
  • New Ulm Medical CenterNew Ulm, United States
  • Mount Sinai ChelseaNew York, United States
  • Mount Sinai HospitalNew York, United States
  • Mount Sinai WestNew York, United States
  • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer CenterNew York, United States
  • Helen F Graham Cancer CenterNewark, United States
  • University of Kansas Cancer Center at North Kansas City HospitalNorth Kansas City, United States
  • Ascension Providence Hospitals - NoviNovi, United States
  • Cancer Care Center of O'FallonO'Fallon, United States
  • Mercy Hospital Oklahoma CityOklahoma City, United States
  • University of Oklahoma Health Sciences CenterOklahoma City, United States
  • Upstate Cancer Center Radiation Oncology at OneidaOneida, United States
  • Saint Alphonsus Medical Center-OntarioOntario, United States
  • Illinois CancerCare-Ottawa ClinicOttawa, United States
  • University of Kansas Cancer Center-Overland ParkOverland Park, United States
  • University of Kansas Hospital-Indian Creek CampusOverland Park, United States
  • Illinois CancerCare-PekinPekin, United States
  • OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment CenterPekin, United States
  • Illinois CancerCare-PeoriaPeoria, United States
  • Methodist Medical Center of IllinoisPeoria, United States
  • OSF Saint Francis Medical CenterPeoria, United States
  • OSF Saint Francis Radiation Oncology at Peoria Cancer CenterPeoria, United States
  • Illinois CancerCare-PeruPeru, United States
  • Valley Radiation OncologyPeru, United States
  • McLaren Cancer Institute-Northern MichiganPetoskey, United States
  • Fox Chase Cancer CenterPhiladelphia, United States
  • Thomas Jefferson University HospitalPhiladelphia, United States
  • Banner-University Medical Center PhoenixPhoenix, United States
  • Mayo Clinic Hospital in ArizonaPhoenix, United States
  • McLaren-Port HuronPort Huron, United States
  • Legacy Good Samaritan Hospital and Medical CenterPortland, United States
  • Kootenai Clinic Cancer Services - Post FallsPost Falls, United States
  • Fairview Northland Medical CenterPrinceton, United States
  • Illinois CancerCare-PrincetonPrinceton, United States
  • Ascension All Saints HospitalRacine, United States
  • Beebe Health CampusRehoboth Beach, United States
  • Virginia Commonwealth University/Massey Cancer CenterRichmond, United States
  • North Memorial Medical Health CenterRobbinsdale, United States
  • Mayo Clinic in RochesterRochester, United States
  • University of RochesterRochester, United States
  • Delbert Day Cancer Institute at PCRMCRolla, United States
  • Mercy Clinic-Rolla-Cancer and HematologyRolla, United States
  • Ascension Saint Mary's HospitalSaginaw, United States
  • Coborn Cancer Center at Saint Cloud HospitalSaint Cloud, United States
  • Heartland Regional Medical CenterSaint Joseph, United States
  • Park Nicollet Clinic - Saint Louis ParkSaint Louis Park, United States
  • Regions HospitalSaint Paul, United States
  • United HospitalSaint Paul, United States
  • Sainte Genevieve County Memorial HospitalSainte Genevieve, United States
  • Huntsman Cancer Institute/University of UtahSalt Lake City, United States
  • Kootenai Cancer ClinicSandpoint, United States
  • Guthrie Medical Group PC-Robert Packer HospitalSayre, United States
  • Maine Medical Center- Scarborough CampusScarborough, United States
  • Mayo Clinic in ArizonaScottsdale, United States
  • Saint Francis Regional Medical CenterShakopee, United States
  • Welch Cancer CenterSheridan, United States
  • Sanford USD Medical Center - Sioux FallsSioux Falls, United States
  • CoxHealth South HospitalSpringfield, United States
  • Memorial Medical CenterSpringfield, United States
  • Mercy Hospital SpringfieldSpringfield, United States
  • Southern Illinois University School of MedicineSpringfield, United States
  • Springfield ClinicSpringfield, United States
  • Mercy Hospital Saint LouisSt Louis, United States
  • Mercy Hospital SouthSt Louis, United States
  • Missouri Baptist Medical CenterSt Louis, United States
  • Saint Louis Cancer and Breast Institute-South CitySt Louis, United States
  • Washington University School of MedicineSt Louis, United States
  • Lakeview HospitalStillwater, United States
  • Stony Brook University Medical CenterStony Brook, United States
  • Missouri Baptist Sullivan HospitalSullivan, United States
  • Missouri Baptist Outpatient Center-Sunset HillsSunset Hills, United States
  • Southwest Illinois Health Services LLPSwansea, United States
  • State University of New York Upstate Medical UniversitySyracuse, United States
  • Moffitt Cancer CenterTampa, United States
  • Saint Joseph's Hospital/Children's Hospital-TampaTampa, United States
  • Community Medical CenterToms River, United States
  • University of Arizona Cancer Center-North CampusTucson, United States
  • Carle Cancer CenterUrbana, United States
  • Ridgeview Medical CenterWaconia, United States
  • Epic Care Cyberknife CenterWalnut Creek, United States
  • Mercy Hospital WashingtonWashington, United States
  • UW Cancer Center at ProHealth CareWaukesha, United States
  • Aspirus Regional Cancer CenterWausau, United States
  • University of Cincinnati Cancer Center-West ChesterWest Chester, United States
  • Lexington Medical CenterWest Columbia, United States
  • University of Kansas Hospital-Westwood Cancer CenterWestwood, United States
  • Rice Memorial HospitalWillmar, United States
  • Novant Health Forsyth Medical CenterWinston-Salem, United States
  • Minnesota Oncology Hematology PA-WoodburyWoodbury, United States
  • Fairview Lakes Medical CenterWyoming, United States

About the trial

What the trial wants to find out

This phase III trial studies how well single fraction stereotactic radiosurgery works compared with fractionated stereotactic radiosurgery in treating patients with cancer that has spread to the brain from other parts of the body (brain metastases) and has been removed by surgery (resected). Single fraction stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue. Fractionated stereotactic radiosurgery delivers multiple, smaller doses of radiation therapy over time. This study may help doctors find out if fractionated stereotactic radiosurgery is better or worse than the usual approach with single fraction stereotactic radiosurgery.

The 2 groups in the trial

  • Arm I (SSRS)Existing treatment, for comparison

    Patients undergo SSRS over 1 session.

    Treatment: Single Fraction Stereotactic Radiosurgery, Quality-of-Life Assessment, and Questionnaire Administration

  • Arm II (FSRS)Treatment being tested

    Patients undergo FSRS over 3 or 5 daily sessions.

    Treatment: Fractionated Stereotactic Radiosurgery, Quality-of-Life Assessment, and Questionnaire Administration

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Phase III Trial of Post-Surgical Single Fraction Stereotactic Radiosurgery (SRS) Compared With Fractionated SRS (FSRS) for Resected Metastatic Brain Disease
Record updated
17 September 2026