ACTIVE_NOT_RECRUITING

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

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Conditions

Metastatic Malignant Neoplasm in the Brain

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Randomized Phase III Trial of Pre-Operative Compared to Post-Operative Stereotactic Radiosurgery in Patients With Resectable Brain Metastases

Quick Facts

Study Start:2022-10-24
Study Completion:2027-03-16
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05438212

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * 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.
  3. * The maximum diameter of any lesions which will not be resected must be =\< 4.0 cm in maximum diameter
  4. * Known active or history of invasive non-central nervous system (CNS) primary cancer based on documented pathologic diagnosis within the past 3 years
  5. * All brain metastases must be located \>= 5 mm from the optic chiasm and outside the brainstem
  6. * Patient is able to medically tolerate surgery and SRS
  7. * Lesions chosen for surgical therapy must be deemed appropriate targets for safe, gross total resection by the treating surgeon
  8. * History/physical examination within 14 days prior to registration
  9. * Age \>= 18
  10. * Karnofsky performance status (KPS) \>= 60 within 14 days prior to registration
  11. * 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
  12. * Participants who are sexually active must agree to use medically acceptable forms of contraception during treatment on this study to prevent pregnancy
  13. * 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
  1. * Prior cranial radiotherapy, including whole brain radiotherapy, or SRS to the resection site
  2. * 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
  3. * Evidence of leptomeningeal disease (LMD)
  4. * 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
  5. * 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
  6. * Primary histology of germ cell tumor, small cell carcinoma or lymphoma
  7. * More than one brain metastasis planned for resection
  8. * Inability to undergo MRI with contrast
  9. * 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
  10. * Note: chemotherapy and immunotherapy outside of this window are allowed

Contacts and Locations

Principal Investigator

Stuart H Burri
PRINCIPAL_INVESTIGATOR
NRG Oncology

Study Locations (Sites)

Saint Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013
United States
Banner University Medical Center - Tucson
Tucson, Arizona, 85719
United States
University of Arizona Cancer Center-North Campus
Tucson, Arizona, 85719
United States
Kaiser Permanente-Anaheim
Anaheim, California, 92806
United States
Sutter Auburn Faith Hospital
Auburn, California, 95602
United States
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn, California, 95603
United States
Kaiser Permanente-Bellflower
Bellflower, California, 90706
United States
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, 92612
United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027
United States
Memorial Medical Center
Modesto, California, 95355
United States
Kaiser Permanente-Ontario
Ontario, California, 91761
United States
Saint Joseph Hospital - Orange
Orange, California, 92868
United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, 92868
United States
Stanford Cancer Institute Palo Alto
Palo Alto, California, 94304
United States
Sutter Cancer Centers Radiation Oncology Services-Roseville
Roseville, California, 95661
United States
Sutter Roseville Medical Center
Roseville, California, 95661
United States
Sutter Medical Center Sacramento
Sacramento, California, 95816
United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817
United States
California Pacific Medical Center-Pacific Campus
San Francisco, California, 94115
United States
UCSF Medical Center-Parnassus
San Francisco, California, 94143
United States
Sutter Pacific Medical Foundation
Santa Rosa, California, 95403
United States
Sutter Solano Medical Center/Cancer Center
Vallejo, California, 94589
United States
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida, 33146
United States
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, 33442
United States
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136
United States
Miami Cancer Institute
Miami, Florida, 33176
United States
UM Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida, 33324
United States
Moffitt Cancer Center-International Plaza
Tampa, Florida, 33607
United States
Moffitt Cancer Center - McKinley Campus
Tampa, Florida, 33612
United States
Moffitt Cancer Center
Tampa, Florida, 33612
United States
Moffitt Cancer Center at Wesley Chapel
Wesley Chapel, Florida, 33544
United States
Grady Health System
Atlanta, Georgia, 30303
United States
Emory University Hospital Midtown
Atlanta, Georgia, 30308
United States
Piedmont Hospital
Atlanta, Georgia, 30309
United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
United States
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342
United States
Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu, Hawaii, 96813
United States
Queen's Cancer Cenrer - POB I
Honolulu, Hawaii, 96813
United States
Queen's Medical Center
Honolulu, Hawaii, 96813
United States
Straub Clinic and Hospital
Honolulu, Hawaii, 96813
United States
University of Hawaii Cancer Center
Honolulu, Hawaii, 96813
United States
Queen's Cancer Center - Kuakini
Honolulu, Hawaii, 96817
United States
The Cancer Center of Hawaii-Liliha
Honolulu, Hawaii, 96817
United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826
United States
Castle Medical Center
Kailua, Hawaii, 96734
United States
Wilcox Memorial Hospital and Kauai Medical Clinic
Lihue, Hawaii, 96766
United States
Hawaii Cancer Care - Westridge
‘Aiea, Hawaii, 96701
United States
Pali Momi Medical Center
‘Aiea, Hawaii, 96701
United States
The Queen's Medical Center - West Oahu
‘Ewa Beach, Hawaii, 96706
United States
Advocate Outpatient Center - Aurora
Aurora, Illinois, 60506
United States
Advocate Good Shepherd Hospital
Barrington, Illinois, 60010
United States
Centralia Oncology Clinic
Centralia, Illinois, 62801
United States
Northwestern University
Chicago, Illinois, 60611
United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637
United States
AMG Crystal Lake - Oncology
Crystal Lake, Illinois, 60014
United States
Carle at The Riverfront
Danville, Illinois, 61832
United States
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526
United States
Decatur Memorial Hospital
Decatur, Illinois, 62526
United States
Advocate Good Samaritan Hospital
Downers Grove, Illinois, 60515
United States
Carle Physician Group-Effingham
Effingham, Illinois, 62401
United States
Crossroads Cancer Center
Effingham, Illinois, 62401
United States
Elmhurst Memorial Hospital
Elmhurst, Illinois, 60126
United States
Advocate South Suburban Hospital
Hazel Crest, Illinois, 60429
United States
AMG Libertyville - Oncology
Libertyville, Illinois, 60048
United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938
United States
Edward Hospital/Cancer Center
Naperville, Illinois, 60540
United States
UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois, 60451
United States
Cancer Care Center of O'Fallon
O'Fallon, Illinois, 62269
United States
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453-2699
United States
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068
United States
Southern Illinois University School of Medicine
Springfield, Illinois, 62702
United States
Springfield Clinic
Springfield, Illinois, 62702
United States
Springfield Memorial Hospital
Springfield, Illinois, 62781
United States
Carle Cancer Center
Urbana, Illinois, 61801
United States
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, 60555
United States
Ascension Saint Vincent Indianapolis Hospital
Indianapolis, Indiana, 46260
United States
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa, 50023
United States
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa, 50325
United States
Iowa Methodist Medical Center
Des Moines, Iowa, 50309
United States
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa, 50309
United States
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa, 50314
United States
UI Health Care Mission Cancer and Blood - Waukee Clinic
Waukee, Iowa, 50263
United States
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201
United States
UM Upper Chesapeake Medical Center
Bel Air, Maryland, 21014
United States
UM Baltimore Washington Medical Center/Tate Cancer Center
Glen Burnie, Maryland, 21061
United States
UM Capital Region Medical Center
Largo, Maryland, 20774
United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201
United States
Weisberg Cancer Treatment Center
Farmington Hills, Michigan, 48334
United States
Corewell Health William Beaumont University Hospital
Royal Oak, Michigan, 48073
United States
Corewell Health Beaumont Troy Hospital
Troy, Michigan, 48085
United States
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, 56401
United States
Essentia Health - Deer River Clinic
Deer River, Minnesota, 56636
United States
Essentia Health Cancer Center
Duluth, Minnesota, 55805
United States
Essentia Health Saint Mary's Medical Center
Duluth, Minnesota, 55805
United States
Miller-Dwan Hospital
Duluth, Minnesota, 55805
United States
Essentia Health Hibbing Clinic
Hibbing, Minnesota, 55746
United States
Coborn Cancer Center at Saint Cloud Hospital
Saint Cloud, Minnesota, 56303
United States
Essentia Health Sandstone
Sandstone, Minnesota, 55072
United States
Essentia Health Virginia Clinic
Virginia, Minnesota, 55792
United States
Parkland Health Center - Farmington
Farmington, Missouri, 63640
United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
United States
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri, 63670
United States
Mercy Hospital Springfield
Springfield, Missouri, 65804
United States
Missouri Baptist Medical Center
St Louis, Missouri, 63131
United States
Missouri Baptist Sullivan Hospital
Sullivan, Missouri, 63080
United States
BJC Outpatient Center at Sunset Hills
Sunset Hills, Missouri, 63127
United States
Billings Clinic Cancer Center
Billings, Montana, 59101
United States
Benefis Sletten Cancer Institute
Great Falls, Montana, 59405
United States
Renown Regional Medical Center
Reno, Nevada, 89502
United States
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, 03756
United States
Cooper Hospital University Medical Center
Camden, New Jersey, 08103
United States
Jersey City Medical Center
Jersey City, New Jersey, 07302
United States
Saint Barnabas Medical Center
Livingston, New Jersey, 07039
United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
United States
Newark Beth Israel Medical Center
Newark, New Jersey, 07112
United States
The Valley Hospital - Luckow Pavilion
Paramus, New Jersey, 07652
United States
Capital Health Medical Center-Hopewell
Pennington, New Jersey, 08534
United States
Valley Health System Ridgewood Campus
Ridgewood, New Jersey, 07450
United States
Community Medical Center
Toms River, New Jersey, 08755
United States
Valley Health System-Hematology/Oncology
Westwood, New Jersey, 07675
United States
New York-Presbyterian/Brooklyn Methodist Hospital
Brooklyn, New York, 11215
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263
United States
The New York Hospital Medical Center of Queens
Flushing, New York, 11355
United States
Northern Westchester Hospital
Mount Kisco, New York, 10549
United States
Mount Sinai Chelsea
New York, New York, 10011
United States
Mount Sinai West
New York, New York, 10019
United States
Mount Sinai Hospital
New York, New York, 10029
United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
United States
Manhattan Eye Ear and Throat Hospital
New York, New York, 10065
United States
NYP/Weill Cornell Medical Center
New York, New York, 10065
United States
Lenox Hill Hospital
New York, New York, 10075
United States
University of Rochester
Rochester, New York, 14642
United States
Stony Brook University Medical Center
Stony Brook, New York, 11794
United States
State University of New York Upstate Medical University
Syracuse, New York, 13210
United States
Montefiore Medical Center-Einstein Campus
The Bronx, New York, 10461
United States
Montefiore Medical Center-Weiler Hospital
The Bronx, New York, 10461
United States
Montefiore Medical Center - Moses Campus
The Bronx, New York, 10467
United States
Good Samaritan University Hospital
West Islip, New York, 11795
United States
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, 28203
United States
Atrium Health Cabarrus/LCI-Concord
Concord, North Carolina, 28025
United States
CaroMont Regional Medical Center
Gastonia, North Carolina, 28054
United States
Novant Health Cancer Institute Radiation Oncology - Wilmington
Wilmington, North Carolina, 28401
United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
United States
Sanford Broadway Medical Center
Fargo, North Dakota, 58122
United States
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122
United States
Indu and Raj Soin Medical Center
Beavercreek, Ohio, 45431
United States
Case Western Reserve University
Cleveland, Ohio, 44106
United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
United States
Riverside Methodist Hospital
Columbus, Ohio, 43214
United States
Grant Medical Center
Columbus, Ohio, 43215
United States
Delaware Health Center-Grady Cancer Center
Delaware, Ohio, 43015
United States
Grady Memorial Hospital
Delaware, Ohio, 43015
United States
Kettering Medical Center
Kettering, Ohio, 45429
United States
Mercy Health - Perrysburg Hospital
Perrysburg, Ohio, 43551
United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
United States
Northeast Radiation Oncology Center
Dunmore, Pennsylvania, 18512
United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
United States
UPMC-Presbyterian Hospital
Pittsburgh, Pennsylvania, 15213
United States
UPMC-Shadyside Hospital
Pittsburgh, Pennsylvania, 15232
United States
Medical University of South Carolina
Charleston, South Carolina, 29425
United States
Gibbs Cancer Center-Gaffney
Gaffney, South Carolina, 29341
United States
Gibbs Cancer Center-Pelham
Greer, South Carolina, 29651
United States
Spartanburg Medical Center
Spartanburg, South Carolina, 29303
United States
SMC Center for Hematology Oncology Union
Union, South Carolina, 29379
United States
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, 57104
United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134
United States
The Children's Hospital at TriStar Centennial
Nashville, Tennessee, 37203
United States
Covenant Medical Center-Lakeside
Lubbock, Texas, 79410
United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112
United States
Inova Schar Cancer Institute
Fairfax, Virginia, 22031
United States
Henrico Doctor's Hospital
Richmond, Virginia, 23229
United States
CJW Medical Center - Johnston-Willis Campus
Richmond, Virginia, 23235
United States
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, 23298
United States
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, 24033
United States
ThedaCare Regional Cancer Center
Appleton, Wisconsin, 54911
United States
Duluth Clinic Ashland
Ashland, Wisconsin, 54806
United States
Northwest Wisconsin Cancer Center
Ashland, Wisconsin, 54806
United States
Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin, 53105
United States
Aurora Health Care Germantown Health Center
Germantown, Wisconsin, 53022
United States
Aurora Cancer Care-Grafton
Grafton, Wisconsin, 53024
United States
Aurora BayCare Medical Center
Green Bay, Wisconsin, 54311
United States
Essentia Health-Hayward Clinic
Hayward, Wisconsin, 54843
United States
University of Wisconsin Carbone Cancer Center - Johnson Creek
Johnson Creek, Wisconsin, 53038
United States
Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin, 53142
United States
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Madison, Wisconsin, 53718
United States
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, 53792
United States
Aurora Cancer Care-Milwaukee
Milwaukee, Wisconsin, 53209
United States
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, 53215
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States
Aurora Sinai Medical Center
Milwaukee, Wisconsin, 53233
United States
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin, 54904
United States
Aurora Cancer Care-Racine
Racine, Wisconsin, 53406
United States
Aspirus Cancer Care - James Beck Cancer Center
Rhinelander, Wisconsin, 54501
United States
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin, 53081
United States
Essentia Health-Spooner Clinic
Spooner, Wisconsin, 54801
United States
Aspirus Cancer Care - Stevens Point
Stevens Point, Wisconsin, 54481
United States
Aurora Medical Center in Summit
Summit, Wisconsin, 53066
United States
Essentia Health Saint Mary's Hospital - Superior
Superior, Wisconsin, 54880
United States
UW Cancer Center at ProHealth Care
Waukesha, Wisconsin, 53188
United States
Aspirus Regional Cancer Center
Wausau, Wisconsin, 54401
United States
Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin, 53226
United States
Aurora West Allis Medical Center
West Allis, Wisconsin, 53227
United States
Aspirus Cancer Care - Wisconsin Rapids
Wisconsin Rapids, Wisconsin, 54494
United States

Collaborators and Investigators

Sponsor: NRG Oncology

  • Stuart H Burri, PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2022-10-24
Study Completion Date2027-03-16

Study Record Updates

Study Start Date2022-10-24
Study Completion Date2027-03-16

Terms related to this study

Additional Relevant MeSH Terms

  • Metastatic Malignant Neoplasm in the Brain