Metastatic Malignant Neoplasm in the BrainPhase 3NCT05438212
Comparing the Addition of Radiation Either Before or After Surgery for Patients With Brain Metastases
A Phase 3 study testing Brain Surgery, Quality-of-Life Assessment and Questionnaire Administration in people with Metastatic Malignant Neoplasm in the Brain, run by NRG Oncology at 216 sites in 3 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Malignant Neoplasm in the Brain
- What is being tested?
- Brain Surgery, Quality-of-Life Assessment and Questionnaire Administration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 237 participants
- Where
- 216 sitesin 3 countries
- Study dates
- 24 Oct 2022to 16 Mar 2032
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Radiographic confirmation of 1-4 brain metastases, one of which requires resection, as defined by magnetic resonance imaging (MRI) with contrast obtained within 14 days prior to registration
- The maximum diameter of the lesion to be resected on the post-contrast MRI, as measured on any orthogonal plane (axial, sagittal, coronal), must measure >= 2.0 cm and =< 5.0 cm.
- The maximum diameter of any lesions which will not be resected must be =< 4.0 cm in maximum diameter
- Known active or history of invasive non-central nervous system (CNS) primary cancer based on documented pathologic diagnosis within the past 3 years
- All brain metastases must be located >= 5 mm from the optic chiasm and outside the brainstem
- Patient is able to medically tolerate surgery and SRS
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- Lesions chosen for surgical therapy must be deemed appropriate targets for safe, gross total resection by the treating surgeon
- History/physical examination within 14 days prior to registration
- Age >= 18
- Karnofsky performance status (KPS) >= 60 within 14 days prior to registration
- A negative urine or serum pregnancy test (in persons of childbearing potential) within =< 14 days prior to registration. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal
- Participants who are sexually active must agree to use medically acceptable forms of contraception during treatment on this study to prevent pregnancy
- The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information
Who cannot join
- Prior cranial radiotherapy, including whole brain radiotherapy, or SRS to the resection site
- Note: The index lesion to be resected cannot have been previously treated with SRS (i.e. repeat radiosurgery to the same location/lesion is not allowed on this protocol). Previous SRS to other lesions is allowed
- Evidence of leptomeningeal disease (LMD)
- Note: For the purposes of exclusion, LMD is a clinical diagnosis, defined as positive cerebrospinal fluid (CSF) cytology and/or unequivocal radiologic or clinical evidence of leptomeningeal involvement. Patients with leptomeningeal symptoms in the setting of leptomeningeal enhancement by imaging (MRI) would be considered to have LMD even in the absence of positive CSF cytology. In contrast, an asymptomatic or minimally symptomatic patient with mild or nonspecific leptomeningeal enhancement (MRI) would not be considered to have LMD. In that patient, CSF sampling is not required to formally exclude LMD, but can be performed at the investigator's discretion based on level of clinical suspicion
- Any medical conditions which would make this protocol unreasonably hazardous, including, but not limited to: contraindications to general endotracheal anesthesia; intracranial surgery; and stereotactic radiosurgery
- Primary histology of germ cell tumor, small cell carcinoma or lymphoma
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- More than one brain metastasis planned for resection
- Inability to undergo MRI with contrast
- Planned administration of cytotoxic chemotherapy or tyrosine/multi-kinase inhibitors within the 3 days prior to, the day of, or within 3 days after the completion of SRS
- Note: chemotherapy and immunotherapy outside of this window are allowed
Trial locations and contacts
216 sites in 3 countries.
216 sites in 3 countries
United States208 sites
Hawaii Cancer Care - Westridge
‘Aiea, Hawaii, 96701
Pali Momi Medical Center
‘Aiea, Hawaii, 96701
The Queen's Medical Center - West Oahu
‘Ewa Beach, Hawaii, 96706
Kaiser Permanente-Anaheim
Anaheim, California, 92806
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa, 50023
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109
ThedaCare Regional Cancer Center
Appleton, Wisconsin, 54911
Duluth Clinic Ashland
Ashland, Wisconsin, 54806
Northwest Wisconsin Cancer Center
Ashland, Wisconsin, 54806
Grady Health System
Atlanta, Georgia, 30303
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Piedmont Hospital
Atlanta, Georgia, 30309
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342
Sutter Auburn Faith Hospital
Auburn, California, 95602
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn, California, 95603
Advocate Outpatient Center - Aurora
Aurora, Illinois, 60506
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201
Advocate Good Shepherd Hospital
Barrington, Illinois, 60010
Indu and Raj Soin Medical Center
Beavercreek, Ohio, 45431
UM Upper Chesapeake Medical Center
Bel Air, Maryland, 21014
Kaiser Permanente-Bellflower
Bellflower, California, 90706
Billings Clinic Cancer Center
Billings, Montana, 59101
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, 56401
New York-Presbyterian/Brooklyn Methodist Hospital
Brooklyn, New York, 11215
Roswell Park Cancer Institute
Buffalo, New York, 14263
Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin, 53105
Cooper Hospital University Medical Center
Camden, New Jersey, 08103
Centralia Oncology Clinic
Centralia, Illinois, 62801
Medical University of South Carolina
Charleston, South Carolina, 29425
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, 28203
Northwestern University
Chicago, Illinois, 60611
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637
Case Western Reserve University
Cleveland, Ohio, 44106
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa, 50325
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Riverside Methodist Hospital
Columbus, Ohio, 43214
Grant Medical Center
Columbus, Ohio, 43215
Atrium Health Cabarrus/LCI-Concord
Concord, North Carolina, 28025
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida, 33146
AMG Crystal Lake - Oncology
Crystal Lake, Illinois, 60014
Carle at The Riverfront
Danville, Illinois, 61832
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526
Decatur Memorial Hospital
Decatur, Illinois, 62526
Essentia Health - Deer River Clinic
Deer River, Minnesota, 56636
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, 33442
Delaware Health Center-Grady Cancer Center
Delaware, Ohio, 43015
Grady Memorial Hospital
Delaware, Ohio, 43015
Iowa Methodist Medical Center
Des Moines, Iowa, 50309
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa, 50309
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa, 50314
UM Sylvester Comprehensive Cancer Center at Doral
Doral, Florida, 33166
Advocate Good Samaritan Hospital
Downers Grove, Illinois, 60515
Essentia Health Cancer Center
Duluth, Minnesota, 55805
Essentia Health Saint Mary's Medical Center
Duluth, Minnesota, 55805
Miller-Dwan Hospital
Duluth, Minnesota, 55805
Northeast Radiation Oncology Center
Dunmore, Pennsylvania, 18512
Carle Physician Group-Effingham
Effingham, Illinois, 62401
Crossroads Cancer Center
Effingham, Illinois, 62401
Elmhurst Memorial Hospital
Elmhurst, Illinois, 60126
Inova Schar Cancer Institute
Fairfax, Virginia, 22031
Sanford Broadway Medical Center
Fargo, North Dakota, 58122
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122
Parkland Health Center - Farmington
Farmington, Missouri, 63640
Weisberg Cancer Treatment Center
Farmington Hills, Michigan, 48334
The New York Hospital Medical Center of Queens
Flushing, New York, 11355
Gibbs Cancer Center-Gaffney
Gaffney, South Carolina, 29341
CaroMont Regional Medical Center
Gastonia, North Carolina, 28054
Aurora Health Care Germantown Health Center
Germantown, Wisconsin, 53022
UM Baltimore Washington Medical Center/Tate Cancer Center
Glen Burnie, Maryland, 21061
Aurora Cancer Care-Grafton
Grafton, Wisconsin, 53024
Benefis Sletten Cancer Institute
Great Falls, Montana, 59405
Aurora BayCare Medical Center
Green Bay, Wisconsin, 54311
Gibbs Cancer Center-Pelham
Greer, South Carolina, 29651
Essentia Health-Hayward Clinic
Hayward, Wisconsin, 54843
Advocate South Suburban Hospital
Hazel Crest, Illinois, 60429
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
Essentia Health Hibbing Clinic
Hibbing, Minnesota, 55746
Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu, Hawaii, 96813
Queen's Cancer Cenrer - POB I
Honolulu, Hawaii, 96813
Queen's Medical Center
Honolulu, Hawaii, 96813
Straub Clinic and Hospital
Honolulu, Hawaii, 96813
University of Hawaii Cancer Center
Honolulu, Hawaii, 96813
Queen's Cancer Center - Kuakini
Honolulu, Hawaii, 96817
The Cancer Center of Hawaii-Liliha
Honolulu, Hawaii, 96817
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826
Ascension Saint Vincent Indianapolis Hospital
Indianapolis, Indiana, 46260
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, 92612
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
Jersey City Medical Center
Jersey City, New Jersey, 07302
University of Wisconsin Carbone Cancer Center - Johnson Creek
Johnson Creek, Wisconsin, 53038
Castle Medical Center
Kailua, Hawaii, 96734
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin, 53142
Kettering Medical Center
Kettering, Ohio, 45429
UM Capital Region Medical Center
Largo, Maryland, 20774
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, 03756
AMG Libertyville - Oncology
Libertyville, Illinois, 60048
Wilcox Memorial Hospital and Kauai Medical Clinic
Lihue, Hawaii, 96766
Saint Barnabas Medical Center
Livingston, New Jersey, 07039
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027
Norton Brownsboro Hospital and Medical Campus
Louisville, Kentucky, 40241
Covenant Medical Center-Lakeside
Lubbock, Texas, 79410
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Madison, Wisconsin, 53718
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, 53792
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136
Miami Cancer Institute
Miami, Florida, 33176
Aurora Cancer Care-Milwaukee
Milwaukee, Wisconsin, 53209
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, 53215
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Aurora Sinai Medical Center
Milwaukee, Wisconsin, 53233
Memorial Medical Center
Modesto, California, 95355
Northern Westchester Hospital
Mount Kisco, New York, 10549
Edward Hospital/Cancer Center
Naperville, Illinois, 60540
The Children's Hospital at TriStar Centennial
Nashville, Tennessee, 37203
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois, 60451
Mount Sinai Chelsea
New York, New York, 10011
Mount Sinai West
New York, New York, 10019
Mount Sinai Hospital
New York, New York, 10029
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
Manhattan Eye Ear and Throat Hospital
New York, New York, 10065
NYP/Weill Cornell Medical Center
New York, New York, 10065
Lenox Hill Hospital
New York, New York, 10075
Newark Beth Israel Medical Center
Newark, New Jersey, 07112
Cancer Care Center of O'Fallon
O'Fallon, Illinois, 62269
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453-2699
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Kaiser Permanente-Ontario
Ontario, California, 91761
Saint Joseph Hospital - Orange
Orange, California, 92868
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, 92868
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin, 54904
Stanford Cancer Institute Palo Alto
Palo Alto, California, 94304
The Valley Hospital - Luckow Pavilion
Paramus, New Jersey, 07652
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068
Capital Health Medical Center-Hopewell
Pennington, New Jersey, 08534
Mercy Health - Perrysburg Hospital
Perrysburg, Ohio, 43551
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Saint Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013
UPMC-Presbyterian Hospital
Pittsburgh, Pennsylvania, 15213
UPMC-Shadyside Hospital
Pittsburgh, Pennsylvania, 15232
UM Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida, 33324
Aurora Cancer Care-Racine
Racine, Wisconsin, 53406
Renown Regional Medical Center
Reno, Nevada, 89502
Aspirus Cancer Care - James Beck Cancer Center
Rhinelander, Wisconsin, 54501
Henrico Doctor's Hospital
Richmond, Virginia, 23229
CJW Medical Center - Johnston-Willis Campus
Richmond, Virginia, 23235
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, 23298
Valley Health System Ridgewood Campus
Ridgewood, New Jersey, 07450
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, 24033
University of Rochester
Rochester, New York, 14642
Sutter Cancer Centers Radiation Oncology Services-Roseville
Roseville, California, 95661
Sutter Roseville Medical Center
Roseville, California, 95661
Corewell Health William Beaumont University Hospital
Royal Oak, Michigan, 48073
Sutter Medical Center Sacramento
Sacramento, California, 95816
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817
Coborn Cancer Center at Saint Cloud Hospital
Saint Cloud, Minnesota, 56303
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri, 63670
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112
California Pacific Medical Center-Pacific Campus
San Francisco, California, 94115
UCSF Medical Center-Parnassus
San Francisco, California, 94143
Essentia Health Sandstone
Sandstone, Minnesota, 55072
Sutter Pacific Medical Foundation
Santa Rosa, California, 95403
Swedish Medical Center-Cherry Hill
Seattle, Washington, 98122-5711
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin, 53081
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, 57104
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134
Spartanburg Medical Center
Spartanburg, South Carolina, 29303
Essentia Health-Spooner Clinic
Spooner, Wisconsin, 54801
Southern Illinois University School of Medicine
Springfield, Illinois, 62702
Springfield Clinic
Springfield, Illinois, 62702
Springfield Memorial Hospital
Springfield, Illinois, 62781
Mercy Hospital Springfield
Springfield, Missouri, 65804
Missouri Baptist Medical Center
St Louis, Missouri, 63131
Aspirus Cancer Care - Stevens Point
Stevens Point, Wisconsin, 54481
Stony Brook University Medical Center
Stony Brook, New York, 11794
Missouri Baptist Sullivan Hospital
Sullivan, Missouri, 63080
Aurora Medical Center in Summit
Summit, Wisconsin, 53066
BJC Outpatient Center at Sunset Hills
Sunset Hills, Missouri, 63127
Essentia Health Saint Mary's Hospital - Superior
Superior, Wisconsin, 54880
State University of New York Upstate Medical University
Syracuse, New York, 13210
Moffitt Cancer Center-International Plaza
Tampa, Florida, 33607
Moffitt Cancer Center - McKinley Campus
Tampa, Florida, 33612
Moffitt Cancer Center
Tampa, Florida, 33612
Montefiore Medical Center-Einstein Campus
The Bronx, New York, 10461
Montefiore Medical Center-Weiler Hospital
The Bronx, New York, 10461
Montefiore Medical Center - Moses Campus
The Bronx, New York, 10467
Community Medical Center
Toms River, New Jersey, 08755
Corewell Health Beaumont Troy Hospital
Troy, Michigan, 48085
Banner University Medical Center - Tucson
Tucson, Arizona, 85719
University of Arizona Cancer Center-North Campus
Tucson, Arizona, 85719
SMC Center for Hematology Oncology Union
Union, South Carolina, 29379
Carle Cancer Center
Urbana, Illinois, 61801
Sutter Solano Medical Center/Cancer Center
Vallejo, California, 94589
Essentia Health Virginia Clinic
Virginia, Minnesota, 55792
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, 60555
UI Health Care Mission Cancer and Blood - Waukee Clinic
Waukee, Iowa, 50263
UW Cancer Center at ProHealth Care
Waukesha, Wisconsin, 53188
Aspirus Regional Cancer Center
Wausau, Wisconsin, 54401
Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin, 53226
Moffitt Cancer Center at Wesley Chapel
Wesley Chapel, Florida, 33544
Aurora West Allis Medical Center
West Allis, Wisconsin, 53227
Good Samaritan University Hospital
West Islip, New York, 11795
Valley Health System-Hematology/Oncology
Westwood, New Jersey, 07675
Novant Health Cancer Institute Radiation Oncology - Wilmington
Wilmington, North Carolina, 28401
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
Aspirus Cancer Care - Wisconsin Rapids
Wisconsin Rapids, Wisconsin, 54494
Japan5 sites
Gunma University Hospital
Gunma, Maebashi, 371-8511
Kyoto University Hospital
Kyoto, 606-8507
Hokkaido University Hospital
Sapporo, Hokkaido, 060-8648
Nagoya University Hospital
Showa-Ku Nagoya, 466-0065
National Cancer Center Hospital
Tokyo, 104 0045
Canada3 sites
CHUM - Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2X 3E4
The Research Institute of the McGill University Health Centre (MUHC)
Montreal, Quebec, H3H 2R9
CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)
Québec, Quebec, G1R 2J6
About this study
Official title: A Randomized Phase III Trial of Pre-Operative Compared to Post-Operative Stereotactic Radiosurgery in Patients With Resectable Brain Metastases
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.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine if the time to composite adverse endpoint (CAE) (defined as: 1) local tumor progression within the surgical bed; and/or 2) adverse radiation effect [ARE], the imaging correlate of post-stereotactic radiosurgery [SRS] radiation necrosis; and/or 3) nodular meningeal disease [nMD]) is improved in patients treated with pre-resection SRS to the intact lesion versus those treated with post-resection SRS.
SECONDARY OBJECTIVES:
- To assess the trajectory of symptom burden in patients treated with pre-resection SRS to the intact lesion versus those treated to the post-resection surgical cavity as measured by MD Anderson Symptom Inventory for brain tumor (MDASI-BT).
II. To determine whether there is improved overall survival (OS) in patients with resected brain metastases who undergo pre-resection SRS compared to patients who receive post-resection SRS.
III. To compare rates of ARE, the imaging correlate of radiation necrosis, in patients who receive pre-resection SRS to patients who receive post-resection SRS.
IV. To determine whether there is increased time to whole brain radiotherapy (WBRT) in patients who receive pre-resection SRS compared to patients who receive post-resection SRS.
- To assess the trajectory of neuro-cognitive function in patients treated with pre-resection SRS to the intact lesion versus those treated to the post-resection surgical cavity as measured by the Montreal Cognitive Assessment (MoCA).
VI. To compare rates of nodular meningeal disease in patients who receive pre-resection SRS to patients who receive post-resection SRS.
VII. To compare rates of local recurrence in the resection cavity for patients who receive pre-resection SRS to patients who receive post-resection SRS.
VIII. To compare rates of local recurrence of intact, non-index metastases treated with SRS.
IX. To compare rates of distant brain failure in patients who receive pre-resection SRS to patients who receive post-resection SRS.
- To assess toxicity in the two treatment arms.
EXPLORATORY OBJECTIVE:
- To explore if the type of surgical resection (piece-meal versus [vs.] en-bloc) may be associated with the rate of nodular meningeal disease.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo surgery per standard of care. Within 10-30 days after surgery, patients undergo stereotactic radiosurgery for 1 fraction.
ARM II: Within 7 days before surgery, patients undergo stereotactic radiosurgery for 1 fraction. Patients undergo surgery per standard of care.
After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for additional 2 years.
- Being tested
- Brain Surgery, Quality-of-Life Assessment, Questionnaire Administration, Stereotactic Radiosurgery
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain SurgeryProcedure or surgery
Undergo surgery per standard of care
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
Stereotactic RadiosurgeryRadiation
Also called SRS, Stereotactic External Beam Irradiation, stereotactic external-beam radiation therapy, Stereotactic Radiation Therapy
Undergo stereotactic radiosurgery
| Study group | Role | What they receive |
|---|---|---|
| Arm I (surgery, stereotactic radiosurgery) | Active comparator | Patients undergo surgery per standard of care. Within 10-30 days after surgery, patients undergo stereotactic radiosurgery for 1 fraction. Receives: Procedure: Brain Surgery; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Radiation: Stereotactic Radiosurgery |
| Arm II (stereotactic radiosurgery, surgery) | Experimental | Within 7 days before surgery, patients undergo stereotactic radiosurgery for 1 fraction. Patients undergo surgery per standard of care. Receives: Procedure: Brain Surgery; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Radiation: Stereotactic Radiosurgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to composite adverse endpoint (CAE)
Analysis for this endpoint will consist of testing the cause-specific hazard ratio in a Cox proportional hazards model.
Measured: Time from surgery (with the post-operative MRI as the 'baseline' for purposes of disease assessment) to local tumor progression (within the surgical bed), nodular meningeal disease, or radiation necrosis, whichever occurs first, assessed up to 4 years
Secondary outcomes (8)
Overall survival (OS)
Analysis for this endpoint will consist of estimation of the OS distribution of each treatment arm via the Kaplan-Meier method and a stratified log-rank test.
Measured: Time from randomization to death due to any cause, assessed up to 4 years
Rate of local tumor progression
The time origin for these imaging-based endpoints will be time of surgery (with the post-operative magnetic resonance imaging [MRI] as the 'baseline' for purposes of disease assessment). These analyses will involve estimating the cumulative incidence function of local progression, radiation necrosis, nodular meningeal disease, and distant brain failures in the presence of competing event of deaths. The Gray's test will be used to evaluate the difference in the distribution of local progression between treatment arms.
Measured: Up to 4 years
Rate of radiation necrosis
The time origin for these imaging-based endpoints will be time of surgery (with the post-operative MRI as the 'baseline' for purposes of disease assessment). These analyses will involve estimating the cumulative incidence function of local progression, radiation necrosis, nodular meningeal disease, and distant brain failures in the presence of competing event of deaths. The Gray's test will be used to evaluate the difference in the distribution of radiation necrosis between treatment arms.
Measured: Up to 4 years
Rate of nodular meningeal disease
The time origin for these imaging-based endpoints will be time of surgery (with the post-operative MRI as the 'baseline' for purposes of disease assessment). These analyses will involve estimating the cumulative incidence function of local progression, radiation necrosis, nodular meningeal disease, and distant brain failures in the presence of competing event of deaths. The Gray's test will be used to evaluate the difference in the distribution of nodular meningeal disease between treatment arms.
Measured: Up to 4 years
Rate of distant brain failures
The time origin for these imaging-based endpoints will be time of surgery (with the post-operative MRI as the 'baseline' for purposes of disease assessment). These analyses will involve estimating the cumulative incidence function of local progression, radiation necrosis, nodular meningeal disease, and distant brain failures in the presence of competing event of deaths. The Gray's test will be used to evaluate the difference in the distribution of distant brain failures between treatment arms.
Measured: Up to 4 years
Frequency of adverse events (AEs)
AEs will be graded according to Common Terminology Criteria for Adverse Events version 5.0. Comprehensive summaries of all AEs by treatment arm will be generated and examined. Counts and frequencies of worst (highest score) AE per patient 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 treatment arms. Any frequencies to be tested will be evaluated using the chi-square or exact test as appropriate, with two-sided significance level 0.05.
Measured: Up to 4 years
Change in MD Anderson Symptom Inventory - Brain Tumor (MDASI-BT)
Will implement mixed effects models for repeated measures to evaluate the MDASI-BT scores longitudinally.
Measured: Baseline up to 2 years after surgery
Change in cognitive function
Measured by Montreal Cognitive Assessment (MoCA). Will implement mixed effects models for repeated measures to evaluate the MoCA scores longitudinally.
Measured: Baseline up to 2 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start24 Oct 2022
- Primary completion16 Mar 2027 (estimated)
- Study completion16 Mar 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Metastatic Malignant Neoplasm in the BrainStudies of the same condition, open and under way.
- More trials run by NRG OncologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 237 participants (actual)
Sponsor and investigators
- Lead sponsor
- NRG Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Stuart H Burri, Principal investigator, NRG Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05438212
- Sponsor's protocol ID
- NRG-BN012
- Other IDs
- NCI-2022-04804, NRG-BN012, NRG-BN012, U10CA180868
- Status last verified
- Sep 2026
- First submitted
- 24 Jun 2022
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page
Publications
Prabhu RS, Akinyelu T, Vaslow ZK, Matsui JK, Haghighi N, Dan T, Mishra MV, Murphy ES, Boyles S, Perlow HK, Palmer JD, Udovicich C, Patel TR, Wardak Z, Woodworth GF, Ksendzovsky A, Yang K, Chao ST, Asher AL, Burri SH. Single-Fraction Versus Fractionated Preoperative Radiosurgery for Resected Brain Metastases: A PROPS-BM International Multicenter Cohort Study. Int J Radiat Oncol Biol Phys. 2024 Mar 1;118(3):650-661. doi: 10.1016/j.ijrobp.2023.09.012. Epub 2023 Sep 16.
PubMed 37717787Prabhu RS, Akinyelu T, Vaslow ZK, Matsui JK, Haghighi N, Dan T, Mishra MV, Murphy ES, Boyles S, Perlow HK, Palmer JD, Udovicich C, Patel TR, Wardak Z, Woodworth GF, Ksendzovsky A, Yang K, Chao ST, Asher AL, Burri SH. Risk Factors for Progression and Toxic Effects After Preoperative Stereotactic Radiosurgery for Patients With Resected Brain Metastases. JAMA Oncol. 2023 Aug 1;9(8):1066-1073. doi: 10.1001/jamaoncol.2023.1629.
PubMed 37289451