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

April 28, 2026 updated by: NRG Oncology

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.

Study Overview

Detailed Description

PRIMARY OBJECTIVE:

I. 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:

I. 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.

V. 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.

Study Type

Interventional

Enrollment (Estimated)

269

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Quebec
      • Montreal, Quebec, Canada, H3H 2R9
        • Recruiting
        • The Research Institute of the McGill University Health Centre (MUHC)
        • Contact:
        • Principal Investigator:
          • Christina I. Tsien
      • Chai Wan, Hong Kong
        • Suspended
        • Pamela Youde Nethersole Eastern Hospital
      • Cork, Ireland
        • Recruiting
        • Cork University Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 353 21 4922324
        • Principal Investigator:
          • Martin J. Higgins
      • Cork, Ireland
        • Recruiting
        • Cork Radiation Oncology Associates Limited
        • Contact:
          • Site Public Contact
          • Phone Number: 353 21 4861100
        • Principal Investigator:
          • Paul J. Kelly
    • Co Dublin
      • Dublin, Co Dublin, Ireland, 6
        • Recruiting
        • Saint Lukes Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 353 1 4065000
        • Principal Investigator:
          • David A. Fitzpatrick
      • Dublin, Co Dublin, Ireland, 18
        • Recruiting
        • Beacon Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 353 1 2936691
        • Principal Investigator:
          • Alina M. Mihai
    • Co Galway
      • Galway, Co Galway, Ireland
        • Recruiting
        • University College Hospital Galway
        • Contact:
        • Principal Investigator:
          • Ronan McDermott
    • Arizona
      • Tucson, Arizona, United States, 85719
        • Suspended
        • Banner University Medical Center - Tucson
      • Tucson, Arizona, United States, 85719
        • Suspended
        • University of Arizona Cancer Center-North Campus
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Recruiting
        • University of Arkansas for Medical Sciences
        • Contact:
          • Site Public Contact
          • Phone Number: 501-686-8274
        • Principal Investigator:
          • Fen Xia
    • California
      • Anaheim, California, United States, 92806
        • Recruiting
        • Kaiser Permanente-Anaheim
        • Contact:
        • Principal Investigator:
          • Aakash Batra
      • Bellflower, California, United States, 90706
        • Recruiting
        • Kaiser Permanente-Bellflower
        • Contact:
        • Principal Investigator:
          • Aakash Batra
      • Corona, California, United States, 92882
        • Recruiting
        • City of Hope Corona
        • Principal Investigator:
          • Boryana Eastman
        • Contact:
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Boryana Eastman
      • Encinitas, California, United States, 92024
        • Recruiting
        • UC San Diego Health System - Encinitas
        • Principal Investigator:
          • Jona A. Hattangadi-Gluth
        • Contact:
          • Site Public Contact
          • Phone Number: 760-536-7700
      • Irvine, California, United States, 92618
        • Recruiting
        • City of Hope at Irvine Lennar
        • Contact:
          • Site Public Contact
          • Phone Number: 877-467-3411
        • Principal Investigator:
          • Boryana Eastman
      • Irvine, California, United States, 92612
        • Recruiting
        • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
        • Contact:
        • Principal Investigator:
          • Aaron B. Simon
      • La Jolla, California, United States, 92093
        • Recruiting
        • UC San Diego Moores Cancer Center
        • Principal Investigator:
          • Jona A. Hattangadi-Gluth
        • Contact:
      • Lancaster, California, United States, 93534
        • Recruiting
        • City of Hope Antelope Valley
        • Contact:
        • Principal Investigator:
          • Boryana Eastman
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars Sinai Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 310-423-8965
        • Principal Investigator:
          • Stephen L. Shiao
      • Los Angeles, California, United States, 90027
        • Recruiting
        • Kaiser Permanente Los Angeles Medical Center
        • Contact:
        • Principal Investigator:
          • Aakash Batra
      • Napa, California, United States, 94558
        • Recruiting
        • Providence Queen of The Valley
        • Principal Investigator:
          • Dan S. Zuckerman
        • Contact:
          • Site Public Contact
          • Phone Number: 707-521-3830
      • Ontario, California, United States, 91761
        • Recruiting
        • Kaiser Permanente-Ontario
        • Contact:
        • Principal Investigator:
          • Aakash Batra
      • Orange, California, United States, 92868
        • Recruiting
        • UC Irvine Health/Chao Family Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Aaron B. Simon
      • Palo Alto, California, United States, 94304
        • Recruiting
        • Stanford Cancer Institute Palo Alto
        • Contact:
        • Principal Investigator:
          • Scott G. Soltys
      • San Diego, California, United States, 92103
        • Recruiting
        • UC San Diego Medical Center - Hillcrest
        • Principal Investigator:
          • Jona A. Hattangadi-Gluth
        • Contact:
      • Santa Rosa, California, United States, 95403
        • Recruiting
        • Providence Medical Foundation - Santa Rosa
        • Principal Investigator:
          • Dan S. Zuckerman
        • Contact:
          • Site Public Contact
          • Phone Number: 707-521-3830
      • South Pasadena, California, United States, 91030
        • Recruiting
        • City of Hope South Pasadena
        • Contact:
        • Principal Investigator:
          • Boryana Eastman
      • Torrance, California, United States, 90503
        • Recruiting
        • City of Hope South Bay
        • Contact:
          • Site Public Contact
          • Phone Number: 877-467-3411
        • Principal Investigator:
          • Boryana Eastman
      • Upland, California, United States, 91786
        • Recruiting
        • City of Hope Upland
        • Contact:
        • Principal Investigator:
          • Boryana Eastman
      • Walnut Creek, California, United States, 94598
        • Recruiting
        • John Muir Medical Center-Walnut Creek
        • Principal Investigator:
          • James L. Rembert
        • Contact:
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • UCHealth University of Colorado Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 720-848-0650
        • Principal Investigator:
          • Timothy V. Waxweiler
      • Colorado Springs, Colorado, United States, 80909
        • Recruiting
        • UCHealth Memorial Hospital Central
        • Contact:
          • Site Public Contact
          • Phone Number: 719-365-2406
        • Principal Investigator:
          • Timothy V. Waxweiler
      • Colorado Springs, Colorado, United States, 80920
        • Recruiting
        • Memorial Hospital North
        • Contact:
          • Site Public Contact
          • Phone Number: 719-364-6700
        • Principal Investigator:
          • Timothy V. Waxweiler
      • Fort Collins, Colorado, United States, 80524
        • Recruiting
        • Poudre Valley Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 970-297-6150
        • Principal Investigator:
          • Timothy V. Waxweiler
      • Fort Collins, Colorado, United States, 80528
        • Recruiting
        • Cancer Care and Hematology-Fort Collins
        • Contact:
        • Principal Investigator:
          • Timothy V. Waxweiler
      • Greeley, Colorado, United States, 80631
        • Recruiting
        • UCHealth Greeley Hospital
        • Contact:
        • Principal Investigator:
          • Timothy V. Waxweiler
      • Loveland, Colorado, United States, 80538
        • Recruiting
        • Medical Center of the Rockies
        • Contact:
          • Site Public Contact
          • Phone Number: 970-203-7083
        • Principal Investigator:
          • Timothy V. Waxweiler
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Active, not recruiting
        • Hartford Hospital
      • New Britain, Connecticut, United States, 06050
        • Active, not recruiting
        • The Hospital of Central Connecticut
    • Florida
      • Aventura, Florida, United States, 33180
        • Recruiting
        • UM Sylvester Comprehensive Cancer Center at Aventura
        • Contact:
          • Site Public Contact
          • Phone Number: 954-461-2180
        • Principal Investigator:
          • Benjamin J. Rich
      • Boca Raton, Florida, United States, 33486
        • Recruiting
        • Boca Raton Regional Hospital
        • Principal Investigator:
          • Samuel M. Richter
        • Contact:
          • Site Public Contact
          • Phone Number: 561-955-4800
      • Coral Gables, Florida, United States, 33146
        • Recruiting
        • UM Sylvester Comprehensive Cancer Center at Coral Gables
        • Contact:
          • Site Public Contact
          • Phone Number: 305-243-2647
        • Principal Investigator:
          • Benjamin J. Rich
      • Deerfield Beach, Florida, United States, 33442
        • Recruiting
        • UM Sylvester Comprehensive Cancer Center at Deerfield Beach
        • Contact:
          • Site Public Contact
          • Phone Number: 305-243-2647
        • Principal Investigator:
          • Benjamin J. Rich
      • Doral, Florida, United States, 33166
        • Recruiting
        • UM Sylvester Comprehensive Cancer Center at Doral
        • Contact:
        • Principal Investigator:
          • Benjamin J. Rich
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami Miller School of Medicine-Sylvester Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 305-243-2647
        • Principal Investigator:
          • Benjamin J. Rich
      • Miami, Florida, United States, 33176
        • Recruiting
        • UM Sylvester Comprehensive Cancer Center at Kendall
        • Contact:
          • Site Public Contact
          • Phone Number: 305-243-2647
        • Principal Investigator:
          • Benjamin J. Rich
      • Miami, Florida, United States, 33176
        • Recruiting
        • Miami Cancer Institute
        • Principal Investigator:
          • Rupesh R. Kotecha
        • Contact:
          • Site Public Contact
          • Phone Number: 786-596-2000
      • Plantation, Florida, United States, 33324
        • Recruiting
        • UM Sylvester Comprehensive Cancer Center at Plantation
        • Contact:
          • Site Public Contact
          • Phone Number: 305-243-2647
        • Principal Investigator:
          • Benjamin J. Rich
      • Tampa, Florida, United States, 33607
        • Recruiting
        • Moffitt Cancer Center-International Plaza
        • Contact:
        • Principal Investigator:
          • Daniel Oliver
      • Tampa, Florida, United States, 33612
        • Recruiting
        • Moffitt Cancer Center - McKinley Campus
        • Contact:
        • Principal Investigator:
          • Daniel Oliver
      • Tampa, Florida, United States, 33612
        • Recruiting
        • Moffitt Cancer Center
        • Contact:
        • Principal Investigator:
          • Daniel Oliver
      • Wesley Chapel, Florida, United States, 33544
        • Recruiting
        • Moffitt Cancer Center at Wesley Chapel
        • Contact:
        • Principal Investigator:
          • Daniel Oliver
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University Hospital/Winship Cancer Institute
        • Contact:
          • Site Public Contact
          • Phone Number: 404-778-1868
        • Principal Investigator:
          • Bree R. Eaton
      • Atlanta, Georgia, United States, 30308
        • Recruiting
        • Emory University Hospital Midtown
        • Contact:
          • Site Public Contact
          • Phone Number: 888-946-7447
        • Principal Investigator:
          • Bree R. Eaton
      • Atlanta, Georgia, United States, 30342
        • Recruiting
        • Emory Saint Joseph's Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 404-851-7115
        • Principal Investigator:
          • Bree R. Eaton
      • Atlanta, Georgia, United States, 30309
        • Recruiting
        • Piedmont Hospital
        • Contact:
        • Principal Investigator:
          • Adam W. Nowlan
      • Austell, Georgia, United States, 30106
        • Recruiting
        • WellStar Cobb Hospital
        • Contact:
        • Principal Investigator:
          • Mark P. McLaughlin
      • Marietta, Georgia, United States, 30060
        • Recruiting
        • Wellstar Kennestone Hospital
        • Contact:
        • Principal Investigator:
          • Mark P. McLaughlin
    • Hawaii
      • Honolulu, Hawaii, United States, 96826
        • Recruiting
        • Kapiolani Medical Center for Women and Children
        • Contact:
          • Site Public Contact
          • Phone Number: 808-983-6090
        • Principal Investigator:
          • Jared Hara
      • Honolulu, Hawaii, United States, 96813
        • Recruiting
        • Hawaii Cancer Care Inc - Waterfront Plaza
        • Contact:
        • Principal Investigator:
          • Jared Hara
      • Honolulu, Hawaii, United States, 96813
        • Recruiting
        • Queen's Cancer Cenrer - POB I
        • Contact:
          • Site Public Contact
          • Phone Number: 808-532-0315
        • Principal Investigator:
          • Jared Hara
      • Honolulu, Hawaii, United States, 96813
        • Recruiting
        • Queen's Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 808-545-8548
        • Principal Investigator:
          • Jared Hara
      • Honolulu, Hawaii, United States, 96813
        • Recruiting
        • University of Hawaii Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 808-586-2979
        • Principal Investigator:
          • Jared Hara
      • Honolulu, Hawaii, United States, 96817
        • Recruiting
        • Queen's Cancer Center - Kuakini
        • Contact:
          • Site Public Contact
          • Phone Number: 808-531-8521
        • Principal Investigator:
          • Jared Hara
      • Kailua, Hawaii, United States, 96734
        • Suspended
        • Castle Medical Center
      • Lihue, Hawaii, United States, 96766
        • Recruiting
        • Wilcox Memorial Hospital and Kauai Medical Clinic
        • Contact:
          • Site Public Contact
          • Phone Number: 808-535-7960
        • Principal Investigator:
          • Jared Hara
      • ‘Aiea, Hawaii, United States, 96701
        • Recruiting
        • Hawaii Cancer Care - Westridge
        • Contact:
        • Principal Investigator:
          • Jared Hara
      • ‘Ewa Beach, Hawaii, United States, 96706
        • Recruiting
        • The Queen's Medical Center - West Oahu
        • Contact:
        • Principal Investigator:
          • Jared Hara
    • Illinois
      • Centralia, Illinois, United States, 62801
        • Recruiting
        • Centralia Oncology Clinic
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago Comprehensive Cancer Center
        • Principal Investigator:
          • Steven J. Chmura
        • Contact:
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University
        • Contact:
        • Principal Investigator:
          • Timothy L. Sita
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • Rush MD Anderson Cancer Center
        • Principal Investigator:
          • Ken Tatebe
        • Contact:
      • Danville, Illinois, United States, 61832
        • Recruiting
        • Carle at The Riverfront
        • Contact:
        • Principal Investigator:
          • Sinisa Stanic
      • Decatur, Illinois, United States, 62526
        • Recruiting
        • Cancer Care Specialists of Illinois - Decatur
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Decatur, Illinois, United States, 62526
        • Recruiting
        • Decatur Memorial Hospital
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Effingham, Illinois, United States, 62401
        • Recruiting
        • Carle Physician Group-Effingham
        • Contact:
        • Principal Investigator:
          • Sinisa Stanic
      • Effingham, Illinois, United States, 62401
        • Recruiting
        • Crossroads Cancer Center
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Elmhurst, Illinois, United States, 60126
        • Recruiting
        • Elmhurst Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Oh-Hoon Kwon
      • Mattoon, Illinois, United States, 61938
        • Recruiting
        • Carle Physician Group-Mattoon/Charleston
        • Contact:
        • Principal Investigator:
          • Sinisa Stanic
      • Maywood, Illinois, United States, 60153
        • Recruiting
        • Loyola University Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 708-226-4357
        • Principal Investigator:
          • Anupama Chundury
      • Naperville, Illinois, United States, 60540
        • Recruiting
        • Edward Hospital/Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 630-646-6075
        • Principal Investigator:
          • Oh-Hoon Kwon
      • New Lenox, Illinois, United States, 60451
        • Recruiting
        • UC Comprehensive Cancer Center at Silver Cross
        • Principal Investigator:
          • Steven J. Chmura
        • Contact:
      • O'Fallon, Illinois, United States, 62269
        • Recruiting
        • Cancer Care Center of O'Fallon
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • O'Fallon, Illinois, United States, 62269
        • Recruiting
        • HSHS Saint Elizabeth's Hospital
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Orland Park, Illinois, United States, 60462
        • Recruiting
        • University of Chicago Medicine-Orland Park
        • Principal Investigator:
          • Steven J. Chmura
        • Contact:
      • Orland Park, Illinois, United States, 60462
      • Shiloh, Illinois, United States, 62269
        • Recruiting
        • Memorial Hospital East
        • Contact:
        • Principal Investigator:
          • Nikhil Rammohan
      • Springfield, Illinois, United States, 62702
        • Recruiting
        • Southern Illinois University School of Medicine
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 217-545-7929
      • Springfield, Illinois, United States, 62702
        • Recruiting
        • Springfield Clinic
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 800-444-7541
      • Springfield, Illinois, United States, 62781
        • Recruiting
        • Springfield Memorial Hospital
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Urbana, Illinois, United States, 61801
        • Recruiting
        • Carle Cancer Center
        • Contact:
        • Principal Investigator:
          • Sinisa Stanic
      • Warrenville, Illinois, United States, 60555
        • Recruiting
        • Northwestern Medicine Cancer Center Warrenville
        • Contact:
        • Principal Investigator:
          • Timothy L. Sita
    • Indiana
      • Crown Point, Indiana, United States, 46307
        • Recruiting
        • Northwest Cancer Center - Main Campus
        • Contact:
          • Site Public Contact
          • Phone Number: 219-310-2550
        • Principal Investigator:
          • Sinisa Stanic
      • Crown Point, Indiana, United States, 46307
        • Recruiting
        • UChicago Medicine Northwest Indiana
        • Principal Investigator:
          • Steven J. Chmura
        • Contact:
      • Dyer, Indiana, United States, 46311
        • Recruiting
        • Northwest Oncology LLC
        • Contact:
          • Site Public Contact
          • Phone Number: 219-924-8178
        • Principal Investigator:
          • Sinisa Stanic
      • Goshen, Indiana, United States, 46526
        • Recruiting
        • Goshen Center for Cancer Care
        • Contact:
        • Principal Investigator:
          • James A. Wheeler
      • Hobart, Indiana, United States, 46342
        • Recruiting
        • Northwest Cancer Center - Hobart
        • Contact:
          • Site Public Contact
          • Phone Number: 219-947-1795
        • Principal Investigator:
          • Sinisa Stanic
      • Hobart, Indiana, United States, 46342
        • Recruiting
        • Saint Mary Medical Center
        • Principal Investigator:
          • Sinisa Stanic
        • Contact:
      • Munster, Indiana, United States, 46321
        • Recruiting
        • The Community Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 219-836-3349
        • Principal Investigator:
          • Sinisa Stanic
      • Munster, Indiana, United States, 46321
        • Recruiting
        • Women's Diagnostic Center - Munster
        • Contact:
        • Principal Investigator:
          • Sinisa Stanic
      • Valparaiso, Indiana, United States, 46383
        • Recruiting
        • Northwest Cancer Center - Valparaiso
        • Principal Investigator:
          • Sinisa Stanic
        • Contact:
    • Iowa
      • Ames, Iowa, United States, 50010
        • Recruiting
        • Mary Greeley Medical Center
        • Principal Investigator:
          • Joseph J. Merchant
        • Contact:
          • Site Public Contact
          • Phone Number: 515-956-4132
      • Ames, Iowa, United States, 50010
        • Recruiting
        • McFarland Clinic - Ames
        • Principal Investigator:
          • Joseph J. Merchant
        • Contact:
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa/Holden Comprehensive Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 800-237-1225
        • Principal Investigator:
          • Kailin Yang
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • University of Kansas Cancer Center
        • Contact:
        • Principal Investigator:
          • Danielle Cunningham
      • Olathe, Kansas, United States, 66061
        • Recruiting
        • The University of Kansas Cancer Center - Olathe
        • Principal Investigator:
          • Danielle Cunningham
        • Contact:
      • Overland Park, Kansas, United States, 66210
        • Recruiting
        • University of Kansas Cancer Center-Overland Park
        • Contact:
        • Principal Investigator:
          • Danielle Cunningham
    • Kentucky
      • Elizabethtown, Kentucky, United States, 42701
        • Recruiting
        • Baptist Health Hardin
        • Contact:
          • Site Public Contact
          • Phone Number: 270-706-5470
        • Principal Investigator:
          • William A. Porter
      • Lexington, Kentucky, United States, 40536
        • Recruiting
        • University of Kentucky/Markey Cancer Center
        • Principal Investigator:
          • Mark E. Bernard
        • Contact:
          • Site Public Contact
          • Phone Number: 859-257-3379
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • The James Graham Brown Cancer Center at University of Louisville
        • Contact:
          • Site Public Contact
          • Phone Number: 502-562-3429
        • Principal Investigator:
          • Adrianna H. Masters
      • Louisville, Kentucky, United States, 40245
        • Recruiting
        • UofL Health Medical Center Northeast
        • Contact:
        • Principal Investigator:
          • Adrianna H. Masters
      • Louisville, Kentucky, United States, 40241
        • Recruiting
        • Norton Brownsboro Hospital and Medical Campus
        • Contact:
        • Principal Investigator:
          • Parag R. Sevak
      • Owensboro, Kentucky, United States, 42303
        • Recruiting
        • Owensboro Health Mitchell Memorial Cancer Center
        • Contact:
        • Principal Investigator:
          • Ryan J. Abel
    • Maine
      • Portland, Maine, United States, 04102
        • Recruiting
        • MaineHealth Maine Medical Center - Portland
        • Principal Investigator:
          • Matthew D. Cheney
        • Contact:
      • Sanford, Maine, United States, 04073
        • Recruiting
        • MaineHealth Cancer Care Center of York County
        • Principal Investigator:
          • Matthew D. Cheney
        • Contact:
          • Site Public Contact
          • Phone Number: 207-459-1600
      • Scarborough, Maine, United States, 04074
        • Recruiting
        • MaineHealth Maine Medical Center- Scarborough
        • Principal Investigator:
          • Matthew D. Cheney
        • Contact:
    • Maryland
      • Baltimore, Maryland, United States, 21215
        • Recruiting
        • Sinai Hospital of Baltimore
        • Principal Investigator:
          • David J. Perry
        • Contact:
          • Site Public Contact
          • Phone Number: 410-601-9083
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • University of Maryland/Greenebaum Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 800-888-8823
        • Principal Investigator:
          • Mark V. Mishra
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • Maryland Proton Treatment Center
        • Contact:
        • Principal Investigator:
          • Mark V. Mishra
      • Bel Air, Maryland, United States, 21014
        • Recruiting
        • UM Upper Chesapeake Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 443-643-3010
        • Principal Investigator:
          • Mark V. Mishra
      • Columbia, Maryland, United States, 21044
        • Recruiting
        • Central Maryland Radiation Oncology in Howard County
        • Contact:
          • Site Public Contact
          • Phone Number: 443-546-1300
        • Principal Investigator:
          • Mark V. Mishra
      • Easton, Maryland, United States, 21601
        • Recruiting
        • University of Maryland Shore Medical Center at Easton
        • Contact:
        • Principal Investigator:
          • Mark V. Mishra
      • Glen Burnie, Maryland, United States, 21061
        • Recruiting
        • UM Baltimore Washington Medical Center/Tate Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 410-553-8100
        • Principal Investigator:
          • Mark V. Mishra
      • Largo, Maryland, United States, 20774
        • Recruiting
        • UM Capital Region Medical Center
        • Principal Investigator:
          • Mark V. Mishra
        • Contact:
      • Westminster, Maryland, United States, 21157
        • Recruiting
        • William E Kahlert Regional Cancer Center/Sinai Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 410-871-6400
        • Principal Investigator:
          • David J. Perry
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan Rogel Cancer Center
        • Principal Investigator:
          • Michelle M. Kim
        • Contact:
      • Ann Arbor, Michigan, United States, 48106
        • Recruiting
        • Trinity Health Saint Joseph Mercy Hospital Ann Arbor
        • Contact:
        • Principal Investigator:
          • Samir Narayan
      • Brighton, Michigan, United States, 48114
        • Recruiting
        • Trinity Health IHA Medical Group Hematology Oncology - Brighton
        • Contact:
        • Principal Investigator:
          • Samir Narayan
      • Brownstown, Michigan, United States, 48183
        • Recruiting
        • Henry Ford Cancer Institute-Downriver
        • Contact:
        • Principal Investigator:
          • Eleanor M. Walker
      • Clinton Township, Michigan, United States, 48038
        • Recruiting
        • Henry Ford Macomb Hospital-Clinton Township
        • Contact:
        • Principal Investigator:
          • Eleanor M. Walker
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Hospital
        • Contact:
        • Principal Investigator:
          • Eleanor M. Walker
      • Livonia, Michigan, United States, 48154
        • Recruiting
        • Trinity Health Saint Mary Mercy Livonia Hospital
        • Contact:
        • Principal Investigator:
          • Samir Narayan
      • Saginaw, Michigan, United States, 48601
      • Tawas City, Michigan, United States, 48764
      • West Bloomfield, Michigan, United States, 48322
        • Recruiting
        • Henry Ford West Bloomfield Hospital
        • Contact:
        • Principal Investigator:
          • Eleanor M. Walker
      • Ypsilanti, Michigan, United States, 48197
        • Recruiting
        • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
        • Contact:
        • Principal Investigator:
          • Samir Narayan
    • Minnesota
      • Maple Grove, Minnesota, United States, 55369
        • Recruiting
        • Fairview Clinics and Surgery Center Maple Grove
        • Contact:
        • Principal Investigator:
          • Charles Shideman
      • Minneapolis, Minnesota, United States, 55415
        • Recruiting
        • Hennepin County Medical Center
        • Contact:
        • Principal Investigator:
          • Charles Shideman
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota/Masonic Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 612-624-2620
        • Principal Investigator:
          • Lindsey Sloan
      • Monticello, Minnesota, United States, 55362
        • Recruiting
        • Monticello Cancer Center
        • Contact:
        • Principal Investigator:
          • Charles Shideman
      • Saint Cloud, Minnesota, United States, 56303
        • Recruiting
        • Coborn Cancer Center at Saint Cloud Hospital
        • Contact:
        • Principal Investigator:
          • Donald J. Jurgens
      • Waconia, Minnesota, United States, 55387
        • Recruiting
        • Ridgeview Medical Center
        • Contact:
        • Principal Investigator:
          • Charles Shideman
    • Missouri
      • City of Saint Peters, Missouri, United States, 63376
        • Recruiting
        • Siteman Cancer Center at Saint Peters Hospital
        • Contact:
        • Principal Investigator:
          • Nikhil Rammohan
      • Columbia, Missouri, United States, 65212
        • Recruiting
        • MU Health - University Hospital/Ellis Fischel Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 573-882-7440
        • Principal Investigator:
          • Mohamed Abdelhakiem
      • Creve Coeur, Missouri, United States, 63141
        • Recruiting
        • Siteman Cancer Center at West County Hospital
        • Contact:
        • Principal Investigator:
          • Nikhil Rammohan
      • Farmington, Missouri, United States, 63640
        • Recruiting
        • Parkland Health Center - Farmington
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 314-996-5569
      • Springfield, Missouri, United States, 65804
        • Recruiting
        • Mercy Hospital Springfield
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 417-269-4520
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Contact:
        • Principal Investigator:
          • Nikhil Rammohan
      • St Louis, Missouri, United States, 63129
        • Recruiting
        • Siteman Cancer Center-South County
        • Contact:
        • Principal Investigator:
          • Nikhil Rammohan
      • St Louis, Missouri, United States, 63136
        • Recruiting
        • Siteman Cancer Center at Christian Hospital
        • Contact:
        • Principal Investigator:
          • Nikhil Rammohan
    • Nebraska
      • Bellevue, Nebraska, United States, 68123
        • Recruiting
        • Nebraska Medicine-Bellevue
        • Contact:
        • Principal Investigator:
          • Weining Zhen
      • Omaha, Nebraska, United States, 68198
        • Recruiting
        • University of Nebraska Medical Center
        • Contact:
        • Principal Investigator:
          • Weining Zhen
      • Omaha, Nebraska, United States, 68118
        • Recruiting
        • Nebraska Medicine-Village Pointe
        • Contact:
          • Site Public Contact
          • Phone Number: 402-559-5600
        • Principal Investigator:
          • Weining Zhen
    • Nevada
      • Reno, Nevada, United States, 89502
        • Recruiting
        • Renown Regional Medical Center
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Recruiting
        • Memorial Sloan Kettering Basking Ridge
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
        • Principal Investigator:
          • Luke R. Pike
      • Cherry Hill, New Jersey, United States, 08002
        • Recruiting
        • Jefferson Cherry Hill Hospital
        • Principal Investigator:
          • Wenyin Shi
        • Contact:
      • Livingston, New Jersey, United States, 07039
        • Recruiting
        • Saint Barnabas Medical Center
        • Contact:
        • Principal Investigator:
          • David Huang
      • Middletown, New Jersey, United States, 07748
        • Recruiting
        • Memorial Sloan Kettering Monmouth
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
        • Principal Investigator:
          • Luke R. Pike
      • Montvale, New Jersey, United States, 07645
        • Recruiting
        • Memorial Sloan Kettering Bergen
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
        • Principal Investigator:
          • Luke R. Pike
      • Neptune City, New Jersey, United States, 07753
        • Recruiting
        • Jersey Shore Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 732-776-4240
        • Principal Investigator:
          • Carlos Eduardo Silva Correia
      • New Brunswick, New Jersey, United States, 08903
        • Recruiting
        • Rutgers Cancer Institute of New Jersey
        • Contact:
          • Site Public Contact
          • Phone Number: 732-235-7356
        • Principal Investigator:
          • David Huang
      • Newark, New Jersey, United States, 07112
        • Recruiting
        • Newark Beth Israel Medical Center
        • Contact:
        • Principal Investigator:
          • David Huang
      • Newark, New Jersey, United States, 07101
        • Recruiting
        • Rutgers New Jersey Medical School
        • Contact:
          • Site Public Contact
          • Phone Number: 732-235-7356
        • Principal Investigator:
          • David Huang
      • Paramus, New Jersey, United States, 07652
      • Ridgewood, New Jersey, United States, 07450
      • Sewell, New Jersey, United States, 08080
        • Recruiting
        • Sidney Kimmel Cancer Center Washington Township
        • Principal Investigator:
          • Wenyin Shi
        • Contact:
      • Somerville, New Jersey, United States, 08876
        • Recruiting
        • Robert Wood Johnson University Hospital Somerset
        • Contact:
        • Principal Investigator:
          • David Huang
      • Toms River, New Jersey, United States, 08755
        • Recruiting
        • Community Medical Center
        • Contact:
        • Principal Investigator:
          • David Huang
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Recruiting
        • University of New Mexico Cancer Center
        • Contact:
        • Principal Investigator:
          • Ramesh Gopal
    • New York
      • Brooklyn, New York, United States, 11215
        • Recruiting
        • New York-Presbyterian/Brooklyn Methodist Hospital
        • Contact:
        • Principal Investigator:
          • Hani L. Ashamalla
      • Brooklyn, New York, United States, 11220
        • Recruiting
        • NYU Langone Hospital - Brooklyn
        • Contact:
        • Principal Investigator:
          • Moses M. Tam
      • Commack, New York, United States, 11725
        • Recruiting
        • Memorial Sloan Kettering Commack
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
        • Principal Investigator:
          • Luke R. Pike
      • East White Plains, New York, United States, 10604
        • Recruiting
        • Memorial Sloan Kettering Westchester
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
        • Principal Investigator:
          • Luke R. Pike
      • Flushing, New York, United States, 11355
        • Recruiting
        • The New York Hospital Medical Center of Queens
        • Contact:
        • Principal Investigator:
          • Andrew Brandmaier
      • Lake Success, New York, United States, 11042
        • Recruiting
        • Northwell Health/Center for Advanced Medicine
        • Contact:
          • Site Public Contact
          • Phone Number: 516-734-8896
        • Principal Investigator:
          • A. G. Wernicke
      • Mineola, New York, United States, 11501
        • Recruiting
        • NYU Langone Hospital - Long Island
        • Contact:
        • Principal Investigator:
          • Moses M. Tam
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
        • Principal Investigator:
          • Luke R. Pike
      • New York, New York, United States, 10011
        • Recruiting
        • Mount Sinai Chelsea
        • Contact:
          • Site Public Contact
          • Phone Number: 212-824-7309
          • Email: CCTO@mssm.edu
        • Principal Investigator:
          • Kunal Sindhu
      • New York, New York, United States, 10016
        • Recruiting
        • Laura and Isaac Perlmutter Cancer Center at NYU Langone
        • Contact:
        • Principal Investigator:
          • Moses M. Tam
      • New York, New York, United States, 10029
        • Recruiting
        • Mount Sinai Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 212-824-7309
          • Email: CCTO@mssm.edu
        • Principal Investigator:
          • Kunal Sindhu
      • New York, New York, United States, 10065
        • Recruiting
        • NYP/Weill Cornell Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 212-746-1848
        • Principal Investigator:
          • Kathryn F. Beal
      • New York, New York, United States, 10075
        • Recruiting
        • Lenox Hill Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 516-734-8896
        • Principal Investigator:
          • A. G. Wernicke
      • New York, New York, United States, 10065
        • Recruiting
        • Manhattan Eye Ear and Throat Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 212-434-4460
        • Principal Investigator:
          • A. G. Wernicke
      • New York, New York, United States, 10019
        • Recruiting
        • Mount Sinai West
        • Contact:
          • Site Public Contact
          • Phone Number: 212-824-7309
          • Email: CCTO@mssm.edu
        • Principal Investigator:
          • Kunal Sindhu
      • Rochester, New York, United States, 14642
        • Recruiting
        • University of Rochester
        • Contact:
          • Site Public Contact
          • Phone Number: 585-275-5830
        • Principal Investigator:
          • Michael T. Milano
      • Stony Brook, New York, United States, 11794
        • Recruiting
        • Stony Brook University Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 800-862-2215
        • Principal Investigator:
          • Samuel Ryu
      • Syracuse, New York, United States, 13210
        • Recruiting
        • State University of New York Upstate Medical University
        • Contact:
          • Site Public Contact
          • Phone Number: 315-464-5476
        • Principal Investigator:
          • Michael D. Mix
      • Syracuse, New York, United States, 13215
        • Recruiting
        • SUNY Upstate Medical Center-Community Campus
        • Contact:
          • Site Public Contact
          • Phone Number: 315-464-5476
        • Principal Investigator:
          • Michael D. Mix
      • The Bronx, New York, United States, 10461
        • Recruiting
        • Montefiore Medical Center-Einstein Campus
        • Principal Investigator:
          • Justin Tang
        • Contact:
      • The Bronx, New York, United States, 10467
        • Recruiting
        • Montefiore Medical Center - Moses Campus
        • Principal Investigator:
          • Justin Tang
        • Contact:
      • The Bronx, New York, United States, 10461
        • Recruiting
        • Montefiore Medical Center-Weiler Hospital
        • Principal Investigator:
          • Justin Tang
        • Contact:
      • Uniondale, New York, United States, 11553
        • Recruiting
        • Memorial Sloan Kettering Nassau
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
        • Principal Investigator:
          • Luke R. Pike
    • North Dakota
      • Fargo, North Dakota, United States, 58122
      • Fargo, North Dakota, United States, 58122
    • Ohio
      • Avon, Ohio, United States, 44011
        • Recruiting
        • UH Seidman Cancer Center at UH Avon Health Center
        • Contact:
          • Site Public Contact
          • Phone Number: 800-641-2422
        • Principal Investigator:
          • Haley K. Perlow
      • Beavercreek, Ohio, United States, 45431
        • Active, not recruiting
        • Indu and Raj Soin Medical Center
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • University of Cincinnati Cancer Center-UC Medical Center
        • Principal Investigator:
          • Kyle Wang
        • Contact:
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • Case Western Reserve University
        • Contact:
        • Principal Investigator:
          • Haley K. Perlow
      • Columbus, Ohio, United States, 43214
        • Recruiting
        • Riverside Methodist Hospital
        • Principal Investigator:
          • Virginia M. Diavolitsis
        • Contact:
      • Columbus, Ohio, United States, 43215
        • Recruiting
        • Grant Medical Center
        • Principal Investigator:
          • Virginia M. Diavolitsis
        • Contact:
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Ohio State University Comprehensive Cancer Center
        • Principal Investigator:
          • Raju R. Raval
        • Contact:
      • Delaware, Ohio, United States, 43015
        • Recruiting
        • Delaware Health Center-Grady Cancer Center
        • Principal Investigator:
          • Virginia M. Diavolitsis
        • Contact:
      • Delaware, Ohio, United States, 43015
        • Recruiting
        • Grady Memorial Hospital
        • Principal Investigator:
          • Virginia M. Diavolitsis
        • Contact:
      • Kettering, Ohio, United States, 45429
        • Active, not recruiting
        • Kettering Medical Center
      • Mentor, Ohio, United States, 44060
        • Recruiting
        • UH Seidman Cancer Center at Lake Health Mentor Campus
        • Contact:
        • Principal Investigator:
          • Haley K. Perlow
      • West Chester, Ohio, United States, 45069
        • Recruiting
        • University of Cincinnati Cancer Center-West Chester
        • Principal Investigator:
          • Kyle Wang
        • Contact:
      • Youngstown, Ohio, United States, 44501
        • Active, not recruiting
        • Saint Elizabeth Youngstown Hospital
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • University of Oklahoma Health Sciences Center
        • Contact:
        • Principal Investigator:
          • Jerry J. Jaboin
    • Oregon
      • Clackamas, Oregon, United States, 97015
        • Recruiting
        • Clackamas Radiation Oncology Center
        • Principal Investigator:
          • Dan S. Zuckerman
        • Contact:
      • Gresham, Oregon, United States, 97030
        • Recruiting
        • Legacy Mount Hood Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 503-413-2150
        • Principal Investigator:
          • Andrew Y. Kee
      • Portland, Oregon, United States, 97213
        • Recruiting
        • Providence Portland Medical Center
        • Principal Investigator:
          • Dan S. Zuckerman
        • Contact:
      • Portland, Oregon, United States, 97225
        • Recruiting
        • Providence Saint Vincent Medical Center
        • Principal Investigator:
          • Dan S. Zuckerman
        • Contact:
      • Portland, Oregon, United States, 97210
        • Recruiting
        • Legacy Good Samaritan Hospital and Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 800-220-4937
          • Email: cancer@lhs.org
        • Principal Investigator:
          • Andrew Y. Kee
      • Tualatin, Oregon, United States, 97062
        • Recruiting
        • Legacy Meridian Park Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 503-413-1742
        • Principal Investigator:
          • Andrew Y. Kee
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18104
        • Recruiting
        • Saint Luke's Cancer Center - Allentown
        • Contact:
          • Site Public Contact
          • Phone Number: 610-776-4714
        • Principal Investigator:
          • David L. Andolino
      • Bethlehem, Pennsylvania, United States, 18015
        • Recruiting
        • Saint Luke's University Hospital-Bethlehem Campus
        • Contact:
          • Site Public Contact
          • Phone Number: 484-503-4151
        • Principal Investigator:
          • David L. Andolino
      • Chambersburg, Pennsylvania, United States, 17201
        • Recruiting
        • Chambersburg Hospital
        • Principal Investigator:
          • Amit B. Shah
        • Contact:
      • Dunmore, Pennsylvania, United States, 18512
        • Recruiting
        • Northeast Radiation Oncology Center
        • Contact:
          • Site Public Contact
          • Phone Number: 888-808-6762
        • Principal Investigator:
          • Wenyin Shi
      • Easton, Pennsylvania, United States, 18045
        • Recruiting
        • Saint Luke's Hospital-Anderson Campus
        • Contact:
        • Principal Investigator:
          • David L. Andolino
      • Hershey, Pennsylvania, United States, 17033-0850
        • Recruiting
        • Penn State Milton S Hershey Medical Center
        • Principal Investigator:
          • Sean S. Mahase
        • Contact:
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Thomas Jefferson University Hospital
        • Principal Investigator:
          • Wenyin Shi
        • Contact:
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • University of Pennsylvania/Abramson Cancer Center
        • Principal Investigator:
          • Emily Lebow
        • Contact:
      • Philadelphia, Pennsylvania, United States, 19114
        • Recruiting
        • Jefferson Torresdale Hospital
        • Principal Investigator:
          • Wenyin Shi
        • Contact:
      • Philadelphia, Pennsylvania, United States, 19103
        • Recruiting
        • NRG Oncology
        • Principal Investigator:
          • Rupesh R. Kotecha
        • Contact:
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • UPMC-Presbyterian Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 412-647-2811
        • Principal Investigator:
          • Andrew H. Zureick
      • Pittsburgh, Pennsylvania, United States, 15232
        • Recruiting
        • UPMC-Shadyside Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 412-621-2334
        • Principal Investigator:
          • Andrew H. Zureick
      • Quakertown, Pennsylvania, United States, 18951
        • Recruiting
        • Saint Luke's Hospital - Upper Bucks Campus
        • Contact:
          • Site Public Contact
          • Phone Number: 610-776-4714
        • Principal Investigator:
          • David L. Andolino
      • Stroudsburg, Pennsylvania, United States, 18360
        • Recruiting
        • Saint Luke's Hospital - Monroe Campus
        • Contact:
        • Principal Investigator:
          • David L. Andolino
      • West Reading, Pennsylvania, United States, 19611
        • Recruiting
        • Reading Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 610-988-9323
        • Principal Investigator:
          • Michael L. Haas
      • York, Pennsylvania, United States, 17403
        • Recruiting
        • WellSpan Health-York Cancer Center
        • Principal Investigator:
          • Amit B. Shah
        • Contact:
          • Site Public Contact
          • Phone Number: 877-441-7957
      • York, Pennsylvania, United States, 17403
        • Recruiting
        • WellSpan Health-York Hospital
        • Principal Investigator:
          • Amit B. Shah
        • Contact:
          • Site Public Contact
          • Phone Number: 877-441-7957
    • South Carolina
      • Greenville, South Carolina, United States, 29601
        • Recruiting
        • Saint Francis Hospital
        • Principal Investigator:
          • Jennifer Vogel
        • Contact:
      • Greenville, South Carolina, United States, 29607
        • Recruiting
        • Saint Francis Cancer Center
        • Principal Investigator:
          • Jennifer Vogel
        • Contact:
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
      • Sioux Falls, South Dakota, United States, 57117-5134
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University/Ingram Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 800-811-8480
        • Principal Investigator:
          • Anthony J. Cmelak
      • Nashville, Tennessee, United States, 37204
        • Recruiting
        • Vanderbilt Breast Center at One Hundred Oaks
        • Contact:
          • Site Public Contact
          • Phone Number: 800-811-8480
        • Principal Investigator:
          • Anthony J. Cmelak
    • Texas
      • Conroe, Texas, United States, 77384
        • Recruiting
        • MD Anderson in The Woodlands
        • Contact:
        • Principal Investigator:
          • Martin C. Tom
      • Houston, Texas, United States, 77030
        • Recruiting
        • M D Anderson Cancer Center
        • Contact:
        • Principal Investigator:
          • Martin C. Tom
      • Houston, Texas, United States, 77030
        • Recruiting
        • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
        • Principal Investigator:
          • Zaid A. Siddiqui
        • Contact:
          • Site Public Contact
          • Phone Number: 713-798-1354
          • Email: burton@bcm.edu
      • Houston, Texas, United States, 77079
        • Recruiting
        • MD Anderson West Houston
        • Contact:
        • Principal Investigator:
          • Martin C. Tom
      • Houston, Texas, United States, 77030
        • Recruiting
        • Memorial Hermann Texas Medical Center
        • Principal Investigator:
          • Mark Amsbaugh
        • Contact:
          • Site Public Contact
          • Phone Number: 713-792-3245
      • League City, Texas, United States, 77573
        • Recruiting
        • MD Anderson League City
        • Contact:
        • Principal Investigator:
          • Martin C. Tom
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • University of Texas Health Science Center at San Antonio
        • Contact:
        • Principal Investigator:
          • Eva M. Galvan
      • Sugar Land, Texas, United States, 77478
        • Recruiting
        • MD Anderson in Sugar Land
        • Contact:
        • Principal Investigator:
          • Martin C. Tom
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Recruiting
        • Huntsman Cancer Institute/University of Utah
        • Principal Investigator:
          • Donald M. Cannon
        • Contact:
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Recruiting
        • University of Vermont Medical Center
        • Principal Investigator:
          • Nataniel H. Lester-Coll
        • Contact:
          • Site Public Contact
          • Phone Number: 802-656-4101
          • Email: rpo@uvm.edu
      • Burlington, Vermont, United States, 05405
        • Recruiting
        • University of Vermont and State Agricultural College
        • Principal Investigator:
          • Nataniel H. Lester-Coll
        • Contact:
          • Site Public Contact
          • Phone Number: 802-656-8990
          • Email: rpo@uvm.edu
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Recruiting
        • VCU Massey Comprehensive Cancer Center
        • Principal Investigator:
          • Timothy J. Harris
        • Contact:
    • Washington
      • Renton, Washington, United States, 98055
        • Recruiting
        • Valley Medical Center
        • Principal Investigator:
          • John A. Ellerton
        • Contact:
      • Vancouver, Washington, United States, 98686
        • Recruiting
        • Legacy Salmon Creek Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 503-413-2150
        • Principal Investigator:
          • Andrew Y. Kee
      • Vancouver, Washington, United States, 98684
        • Recruiting
        • Legacy Cancer Institute Medical Oncology and Day Treatment
        • Contact:
        • Principal Investigator:
          • Andrew Y. Kee
    • Wisconsin
      • Antigo, Wisconsin, United States, 54409
        • Recruiting
        • Langlade Hospital and Cancer Center
        • Contact:
        • Principal Investigator:
          • Andrew J. Huang
      • Appleton, Wisconsin, United States, 54911
        • Recruiting
        • ThedaCare Regional Cancer Center
        • Contact:
        • Principal Investigator:
          • Joseph A. Bovi
      • La Crosse, Wisconsin, United States, 54601
        • Recruiting
        • Gundersen Lutheran Medical Center
        • Contact:
        • Principal Investigator:
          • Collin D. Driscoll
      • Madison, Wisconsin, United States, 53792
        • Recruiting
        • University of Wisconsin Carbone Cancer Center - University Hospital
        • Contact:
        • Principal Investigator:
          • Brett A. Morris
      • Madison, Wisconsin, United States, 53718
        • Recruiting
        • University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
        • Contact:
        • Principal Investigator:
          • Brett A. Morris
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin
        • Contact:
          • Site Public Contact
          • Phone Number: 414-805-3666
        • Principal Investigator:
          • Michael W. Straza
      • Rhinelander, Wisconsin, United States, 54501
        • Recruiting
        • Aspirus Cancer Care - James Beck Cancer Center
        • Principal Investigator:
          • Andrew J. Huang
        • Contact:
      • Stevens Point, Wisconsin, United States, 54481
        • Recruiting
        • Aspirus Cancer Care - Stevens Point
        • Principal Investigator:
          • Andrew J. Huang
        • Contact:
      • Wausau, Wisconsin, United States, 54401
        • Recruiting
        • Aspirus Regional Cancer Center
        • Principal Investigator:
          • Andrew J. Huang
        • Contact:
          • Site Public Contact
          • Phone Number: 877-405-6866
      • Wisconsin Rapids, Wisconsin, United States, 54494
        • Recruiting
        • Aspirus Cancer Care - Wisconsin Rapids
        • Principal Investigator:
          • Andrew J. Huang
        • Contact:
          • Site Public Contact
          • Phone Number: 715-422-7718

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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
    • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Undergo MRI
Other Names:
  • MRI
  • Magnetic Resonance
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MR
  • MR Imaging
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging
  • Magnetic Resonance Imaging (MRI)
  • sMRI
  • Magnetic resonance imaging (procedure)
  • MRIs
  • Structural MRI
Undergo CT
Other Names:
  • CT
  • CAT
  • CAT Scan
  • Computed Axial Tomography
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT Scan
  • tomography
  • Computerized axial tomography (procedure)
  • Computerized Tomography (CT) scan
Undergo SRS
Other Names:
  • Stereotactic External Beam Irradiation
  • stereotactic external-beam radiation therapy
  • Stereotactic Radiotherapy
  • stereotaxic radiation therapy
  • stereotaxic radiosurgery
  • Stereotactic Radiation Therapy
  • SRS
Experimental: ARM II (FSRS)
Patients undergo FSRS over 30-90 minutes for 3 fractions on study. Additionally, patients undergo CT and MRI on study.
Undergo MRI
Other Names:
  • MRI
  • Magnetic Resonance
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MR
  • MR Imaging
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging
  • Magnetic Resonance Imaging (MRI)
  • sMRI
  • Magnetic resonance imaging (procedure)
  • MRIs
  • Structural MRI
Undergo CT
Other Names:
  • CT
  • CAT
  • CAT Scan
  • Computed Axial Tomography
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT Scan
  • tomography
  • Computerized axial tomography (procedure)
  • Computerized Tomography (CT) scan
Undergo FSRS
Other Names:
  • Fractionated Stereotactic Radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intracranial progression-free survival (IPFS)
Time Frame: 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
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.
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
Overall survival
Time Frame: From the date of randomization until death from any cause, assessed up to 5 years
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.
From the date of randomization until death from any cause, assessed up to 5 years
Time to radiation necrosis (TTRN)
Time Frame: From randomization until radiation necrosis, assessed up to 5 years
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).
From randomization until radiation necrosis, assessed up to 5 years
Time to whole brain radiation therapy (WBRT)
Time Frame: Up to 5 years
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.
Up to 5 years
Incidence of adverse events (AEs)
Time Frame: Up to 2 years from start of radiation treatment
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.
Up to 2 years from start of radiation treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to local failure
Time Frame: Up to 5 years
Estimates of the primary outcome treatment effect and the corresponding 95% confidence interval will be provided by sex, race, and ethnicity.
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Rupesh R Kotecha, NRG Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2024

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

June 30, 2028

Study Registration Dates

First Submitted

July 8, 2024

First Submitted That Met QC Criteria

July 8, 2024

First Posted (Actual)

July 15, 2024

Study Record Updates

Last Update Posted (Actual)

May 4, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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