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Active, not recruitingPhase 3

Comparing the Addition of Radiation Either Before or After Surgery for Patients With Brain Metastases

Key facts

Who runs it
NRG Oncology
Where
‘Aiea, ‘Ewa Beach, Anaheim, Ankeny, Ann Arbor, Appleton, Ashland, Atlanta, Auburn, Aurora, Baltimore, Barrington, Beavercreek, Bel Air, Bellflower, Billings, Brainerd, Brooklyn, Buffalo, Burlington, Camden, Centralia, Charleston, Charlotte, Chicago, Cleveland, Clive, Columbus, Concord, Coral Gables, Crystal Lake, Danville, Decatur, Deer River, Deerfield Beach, Delaware, Des Moines, Doral, Downers Grove, Duluth, Dunmore, Effingham, Elmhurst, Fairfax, Fargo, Farmington, Farmington Hills, Flushing, Gaffney, Gastonia, Germantown, Glen Burnie, Grafton, Great Falls, Green Bay, Greer, Hayward, Hazel Crest, Hershey, Hibbing, Honolulu, Indianapolis, Irvine, Jacksonville, Jersey City, Johnson Creek, Kailua, Kansas City, Kenosha, Kettering, Largo, Lebanon, Libertyville, Lihue, Livingston, Los Angeles, Louisville, Lubbock, Madison, Mattoon, Miami, Milwaukee, Modesto, Mount Kisco, Naperville, Nashville, New Brunswick, New Lenox, New York, Newark, O'Fallon, Oak Lawn, Oklahoma City, Ontario, Orange, Oshkosh, Palo Alto, Paramus, Park Ridge, Pennington, Perrysburg, Philadelphia, Phoenix, Pittsburgh, Plantation, Racine, Reno, Rhinelander, Richmond, Ridgewood, Roanoke, Rochester, Roseville, Royal Oak, Sacramento, Saint Cloud, Sainte Genevieve, Salt Lake City, San Francisco, Sandstone, Santa Rosa, Seattle, Sheboygan, Sioux Falls, Spartanburg, Spooner, Springfield, St Louis, Stevens Point, Stony Brook, Sullivan, Summit, Sunset Hills, Superior, Syracuse, Tampa, The Bronx, Toms River, Troy, Tucson, Union, Urbana, Vallejo, Virginia, Warrenville, Waukee, Waukesha, Wausau, Wauwatosa, Wesley Chapel, West Allis, West Islip, Westwood, Wilmington, Winston-Salem, and Wisconsin Rapids, United StatesSee the 208 sitesAlso in 2 other countries, 8 sites
Trial code
Status
Active, not recruiting
Phase
Phase 3
People taking part
237 people enrolled
Started
24 Oct 2022
Expected to end
16 Mar 2032
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Brain Surgery
  • Quality-of-Life Assessment
  • Questionnaire Administration
  • Stereotactic Radiosurgery
Record updated
10 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 18 criteriaShow less

Who can take part

  • Radiographic confirmation of 1-4 brain metastases, one of which requires resection, as defined by magnetic resonance imaging (MRI) with contrast obtained within 14 days prior to registration; The maximum diameter of the lesion to be resected on the post-contrast MRI, as measured on any orthogonal plane (axial, sagittal, coronal), must measure >= 2.0 cm and =< 5.0 cm; The maximum diameter of any lesions which will not be resected must be =< 4.0 cm in maximum diameter
  • Known active or history of invasive non-central nervous system (CNS) primary cancer based on documented pathologic diagnosis within the past 3 years
  • All brain metastases must be located >= 5 mm from the optic chiasm and outside the brainstem
  • Patient is able to medically tolerate surgery and SRS
  • Lesions chosen for surgical therapy must be deemed appropriate targets for safe, gross total resection by the treating surgeon
  • History/physical examination within 14 days prior to registration
  • Age >= 18
  • Karnofsky performance status (KPS) >= 60 within 14 days prior to registration
  • A 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
  • Participants who are sexually active must agree to use medically acceptable forms of contraception during treatment on this study to prevent pregnancy
  • The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information

Who cannot take part

  • Prior cranial radiotherapy, including whole brain radiotherapy, or SRS to the resection site; Note: The index lesion to be resected cannot have been previously treated with SRS (i.e. repeat radiosurgery to the same location/lesion is not allowed on this protocol). Previous SRS to other lesions is allowed
  • More than one brain metastasis planned for resection
  • Planned administration of cytotoxic chemotherapy or tyrosine/multi-kinase inhibitors within the 3 days prior to, the day of, or within 3 days after the completion of SRS; Note: chemotherapy and immunotherapy outside of this window are allowed
  • Evidence of 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
  • Any medical conditions which would make this protocol unreasonably hazardous, including, but not limited to: contraindications to general endotracheal anesthesia; intracranial surgery; and stereotactic radiosurgery
  • Primary histology of germ cell tumor, small cell carcinoma or lymphoma
  • Inability to undergo MRI with contrast

Where in United States

Also in 2 other countries, 8 sites

  • Hawaii Cancer Care - Westridge‘Aiea, United States
  • Pali Momi Medical Center‘Aiea, United States
  • The Queen's Medical Center - West Oahu‘Ewa Beach, United States
  • Kaiser Permanente-AnaheimAnaheim, United States
  • UI Health Care Mission Cancer and Blood - Ankeny ClinicAnkeny, United States
  • University of Michigan Rogel Cancer CenterAnn Arbor, United States
  • ThedaCare Regional Cancer CenterAppleton, United States
  • Duluth Clinic AshlandAshland, 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
  • Grady Health SystemAtlanta, United States
  • Piedmont HospitalAtlanta, United States
  • Sutter Auburn Faith HospitalAuburn, United States
  • Sutter Cancer Centers Radiation Oncology Services-AuburnAuburn, United States
  • Advocate Outpatient Center - AuroraAurora, United States
  • University of Maryland/Greenebaum Cancer CenterBaltimore, United States
  • Advocate Good Shepherd HospitalBarrington, United States
  • Indu and Raj Soin Medical CenterBeavercreek, United States
  • UM Upper Chesapeake Medical CenterBel Air, United States
  • Kaiser Permanente-BellflowerBellflower, United States
  • Billings Clinic Cancer CenterBillings, United States
  • Essentia Health Saint Joseph's Medical CenterBrainerd, United States
  • New York-Presbyterian/Brooklyn Methodist HospitalBrooklyn, United States
  • Roswell Park Cancer InstituteBuffalo, United States
  • Aurora Cancer Care-Southern Lakes VLCCBurlington, United States
  • Cooper Hospital University Medical CenterCamden, United States
  • Centralia Oncology ClinicCentralia, United States
  • Medical University of South CarolinaCharleston, United States
  • Carolinas Medical Center/Levine Cancer InstituteCharlotte, United States
  • Northwestern UniversityChicago, United States
  • University of Chicago Comprehensive Cancer CenterChicago, United States
  • Case Western Reserve UniversityCleveland, United States
  • UI Health Care Mission Cancer and Blood - West Des Moines ClinicClive, United States
  • Grant Medical CenterColumbus, United States
  • Ohio State University Comprehensive Cancer CenterColumbus, United States
  • Riverside Methodist HospitalColumbus, United States
  • Atrium Health Cabarrus/LCI-ConcordConcord, United States
  • UM Sylvester Comprehensive Cancer Center at Coral GablesCoral Gables, United States
  • AMG Crystal Lake - OncologyCrystal Lake, United States
  • Carle at The RiverfrontDanville, United States
  • Cancer Care Specialists of Illinois - DecaturDecatur, United States
  • Decatur Memorial HospitalDecatur, United States
  • Essentia Health - Deer River ClinicDeer River, United States
  • UM Sylvester Comprehensive Cancer Center at Deerfield BeachDeerfield Beach, United States
  • Delaware Health Center-Grady Cancer CenterDelaware, United States
  • Grady Memorial HospitalDelaware, United States
  • Iowa Methodist Medical CenterDes Moines, United States
  • UI Health Care Mission Cancer and Blood - Des Moines ClinicDes Moines, United States
  • UI Health Care Mission Cancer and Blood - Laurel ClinicDes Moines, United States
  • UM Sylvester Comprehensive Cancer Center at DoralDoral, United States
  • Advocate Good Samaritan HospitalDowners Grove, United States
  • Essentia Health Cancer CenterDuluth, United States
  • Essentia Health Saint Mary's Medical CenterDuluth, United States
  • Miller-Dwan HospitalDuluth, United States
  • Northeast Radiation Oncology CenterDunmore, United States
  • Carle Physician Group-EffinghamEffingham, United States
  • Crossroads Cancer CenterEffingham, United States
  • Elmhurst Memorial HospitalElmhurst, United States
  • Inova Schar Cancer InstituteFairfax, United States
  • Sanford Broadway Medical CenterFargo, United States
  • Sanford Roger Maris Cancer CenterFargo, United States
  • Parkland Health Center - FarmingtonFarmington, United States
  • Weisberg Cancer Treatment CenterFarmington Hills, United States
  • The New York Hospital Medical Center of QueensFlushing, United States
  • Gibbs Cancer Center-GaffneyGaffney, United States
  • CaroMont Regional Medical CenterGastonia, United States
  • Aurora Health Care Germantown Health CenterGermantown, United States
  • UM Baltimore Washington Medical Center/Tate Cancer CenterGlen Burnie, United States
  • Aurora Cancer Care-GraftonGrafton, United States
  • Benefis Sletten Cancer InstituteGreat Falls, United States
  • Aurora BayCare Medical CenterGreen Bay, United States
  • Gibbs Cancer Center-PelhamGreer, United States
  • Essentia Health-Hayward ClinicHayward, United States
  • Advocate South Suburban HospitalHazel Crest, United States
  • Penn State Milton S. Hershey Medical CenterHershey, United States
  • Essentia Health Hibbing ClinicHibbing, United States
  • Hawaii Cancer Care Inc - Waterfront PlazaHonolulu, United States
  • Kapiolani Medical Center for Women and ChildrenHonolulu, United States
  • Queen's Cancer Cenrer - POB IHonolulu, United States
  • Queen's Cancer Center - KuakiniHonolulu, United States
  • Queen's Medical CenterHonolulu, United States
  • Straub Clinic and HospitalHonolulu, United States
  • The Cancer Center of Hawaii-LilihaHonolulu, United States
  • University of Hawaii Cancer CenterHonolulu, United States
  • Ascension Saint Vincent Indianapolis HospitalIndianapolis, United States
  • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory CareIrvine, United States
  • Mayo Clinic in FloridaJacksonville, United States
  • Jersey City Medical CenterJersey City, United States
  • University of Wisconsin Carbone Cancer Center - Johnson CreekJohnson Creek, United States
  • Castle Medical CenterKailua, United States
  • Saint Luke's Hospital of Kansas CityKansas City, United States
  • Aurora Cancer Care-Kenosha SouthKenosha, United States
  • Kettering Medical CenterKettering, United States
  • UM Capital Region Medical CenterLargo, United States
  • Dartmouth Hitchcock Medical Center/Dartmouth Cancer CenterLebanon, United States
  • AMG Libertyville - OncologyLibertyville, United States
  • Wilcox Memorial Hospital and Kauai Medical ClinicLihue, United States
  • Saint Barnabas Medical CenterLivingston, United States
  • Kaiser Permanente Los Angeles Medical CenterLos Angeles, United States
  • Norton Brownsboro Hospital and Medical CampusLouisville, United States
  • Covenant Medical Center-LakesideLubbock, United States
  • University of Wisconsin Carbone Cancer Center - Eastpark Medical CenterMadison, United States
  • University of Wisconsin Carbone Cancer Center - University HospitalMadison, United States
  • Carle Physician Group-Mattoon/CharlestonMattoon, United States
  • Miami Cancer InstituteMiami, United States
  • University of Miami Miller School of Medicine-Sylvester Cancer CenterMiami, United States
  • Aurora Cancer Care-MilwaukeeMilwaukee, United States
  • Aurora Saint Luke's Medical CenterMilwaukee, United States
  • Aurora Sinai Medical CenterMilwaukee, United States
  • Medical College of WisconsinMilwaukee, United States
  • Memorial Medical CenterModesto, United States
  • Northern Westchester HospitalMount Kisco, United States
  • Edward Hospital/Cancer CenterNaperville, United States
  • The Children's Hospital at TriStar CentennialNashville, United States
  • Rutgers Cancer Institute of New JerseyNew Brunswick, United States
  • UC Comprehensive Cancer Center at Silver CrossNew Lenox, United States
  • Lenox Hill HospitalNew York, United States
  • Manhattan Eye Ear and Throat HospitalNew York, 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
  • NYP/Weill Cornell Medical CenterNew York, United States
  • Newark Beth Israel Medical CenterNewark, United States
  • Cancer Care Center of O'FallonO'Fallon, United States
  • Advocate Christ Medical CenterOak Lawn, United States
  • University of Oklahoma Health Sciences CenterOklahoma City, United States
  • Kaiser Permanente-OntarioOntario, United States
  • Saint Joseph Hospital - OrangeOrange, United States
  • UC Irvine Health- Chao Family Comprehensive Cancer CenterOrange, United States
  • Vince Lombardi Cancer Clinic - OshkoshOshkosh, United States
  • Stanford Cancer Institute Palo AltoPalo Alto, United States
  • The Valley Hospital - Luckow PavilionParamus, United States
  • Advocate Lutheran General HospitalPark Ridge, United States
  • Capital Health Medical Center-HopewellPennington, United States
  • Mercy Health - Perrysburg HospitalPerrysburg, United States
  • Thomas Jefferson University HospitalPhiladelphia, United States
  • Saint Joseph's Hospital and Medical CenterPhoenix, United States
  • UPMC Presbyterian HospitalPittsburgh, United States
  • UPMC-Shadyside HospitalPittsburgh, United States
  • UM Sylvester Comprehensive Cancer Center at PlantationPlantation, United States
  • Aurora Cancer Care-RacineRacine, United States
  • Renown Regional Medical CenterReno, United States
  • Aspirus Cancer Care - James Beck Cancer CenterRhinelander, United States
  • CJW Medical Center - Johnston-Willis CampusRichmond, United States
  • Henrico Doctor's HospitalRichmond, United States
  • VCU Massey Comprehensive Cancer CenterRichmond, United States
  • Valley Health System Ridgewood CampusRidgewood, United States
  • Carilion Roanoke Memorial HospitalRoanoke, United States
  • University of RochesterRochester, United States
  • Sutter Cancer Centers Radiation Oncology Services-RosevilleRoseville, United States
  • Sutter Roseville Medical CenterRoseville, United States
  • Corewell Health William Beaumont University HospitalRoyal Oak, United States
  • Sutter Medical Center SacramentoSacramento, United States
  • University of California Davis Comprehensive Cancer CenterSacramento, United States
  • Coborn Cancer Center at Saint Cloud HospitalSaint Cloud, United States
  • Sainte Genevieve County Memorial HospitalSainte Genevieve, United States
  • Huntsman Cancer Institute/University of UtahSalt Lake City, United States
  • California Pacific Medical Center-Pacific CampusSan Francisco, United States
  • UCSF Medical Center-ParnassusSan Francisco, United States
  • Essentia Health SandstoneSandstone, United States
  • Sutter Pacific Medical FoundationSanta Rosa, United States
  • Swedish Medical Center-Cherry HillSeattle, United States
  • Vince Lombardi Cancer Clinic-SheboyganSheboygan, United States
  • Sanford Cancer Center Oncology ClinicSioux Falls, United States
  • Sanford USD Medical Center - Sioux FallsSioux Falls, United States
  • Spartanburg Medical CenterSpartanburg, United States
  • Essentia Health-Spooner ClinicSpooner, United States
  • Mercy Hospital SpringfieldSpringfield, United States
  • Southern Illinois University School of MedicineSpringfield, United States
  • Springfield ClinicSpringfield, United States
  • Springfield Memorial HospitalSpringfield, United States
  • Missouri Baptist Medical CenterSt Louis, United States
  • Aspirus Cancer Care - Stevens PointStevens Point, United States
  • Stony Brook University Medical CenterStony Brook, United States
  • Missouri Baptist Sullivan HospitalSullivan, United States
  • Aurora Medical Center in SummitSummit, United States
  • BJC Outpatient Center at Sunset HillsSunset Hills, United States
  • Essentia Health Saint Mary's Hospital - SuperiorSuperior, United States
  • State University of New York Upstate Medical UniversitySyracuse, United States
  • Moffitt Cancer CenterTampa, United States
  • Moffitt Cancer Center - McKinley CampusTampa, United States
  • Moffitt Cancer Center-International PlazaTampa, United States
  • Montefiore Medical Center - Moses CampusThe Bronx, United States
  • Montefiore Medical Center-Einstein CampusThe Bronx, United States
  • Montefiore Medical Center-Weiler HospitalThe Bronx, United States
  • Community Medical CenterToms River, United States
  • Corewell Health Beaumont Troy HospitalTroy, United States
  • Banner University Medical Center - TucsonTucson, United States
  • University of Arizona Cancer Center-North CampusTucson, United States
  • SMC Center for Hematology Oncology UnionUnion, United States
  • Carle Cancer CenterUrbana, United States
  • Sutter Solano Medical Center/Cancer CenterVallejo, United States
  • Essentia Health Virginia ClinicVirginia, United States
  • Northwestern Medicine Cancer Center WarrenvilleWarrenville, United States
  • UI Health Care Mission Cancer and Blood - Waukee ClinicWaukee, United States
  • UW Cancer Center at ProHealth CareWaukesha, United States
  • Aspirus Regional Cancer CenterWausau, United States
  • Aurora Cancer Care-Milwaukee WestWauwatosa, United States
  • Moffitt Cancer Center at Wesley ChapelWesley Chapel, United States
  • Aurora West Allis Medical CenterWest Allis, United States
  • Good Samaritan University HospitalWest Islip, United States
  • Valley Health System-Hematology/OncologyWestwood, United States
  • Novant Health Cancer Institute Radiation Oncology - WilmingtonWilmington, United States
  • Wake Forest University Health SciencesWinston-Salem, United States
  • Aspirus Cancer Care - Wisconsin RapidsWisconsin Rapids, United States

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Arm I (surgery, stereotactic radiosurgery)Existing treatment, for comparison

    Patients undergo surgery per standard of care. Within 10-30 days after surgery, patients undergo stereotactic radiosurgery for 1 fraction.

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

  • Arm II (stereotactic radiosurgery, surgery)Treatment being tested

    Within 7 days before surgery, patients undergo stereotactic radiosurgery for 1 fraction. Patients undergo surgery per standard of care.

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

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Randomized Phase III Trial of Pre-Operative Compared to Post-Operative Stereotactic Radiosurgery in Patients With Resectable Brain Metastases
Record updated
10 September 2026