Brain cancer trial halted early: can Memory-Sparing radiation help when tumors return?
NCT ID NCT04588246
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase III trial compared two radiation strategies for cancer that had spread to the brain and returned in new spots after initial radiosurgery. One group received focused radiation only to the new tumors, while the other received whole brain radiation that avoided the memory center, plus a drug to protect thinking. The study was stopped early after enrolling only 19 people, so it cannot provide clear answers.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- radiation therapy (whole brain radiotherapy with hippocampal avoidance and memantine, or stereotactic radiosurgery)
- What this could lead to
- If successful, this could show that adding whole brain radiotherapy with memory-sparing techniques helps control brain metastases that come back after initial radiosurgery.
- What could go wrong
- The trial was terminated early with only 19 participants, so results are very limited and no firm conclusions can be drawn. The approach also carries risks of cognitive side effects from radiation.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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19 people
The number who actually took part.
- Started
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Aug 2021
- Finished
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Aug 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients must have developed their distant brain relapse(s) at least 8 weeks after last SRS and within 21 days prior to randomization * Distant brain relapse lesions to be treated must measure =\< 3.0 cm in maximal extent and total volume of distant brain relapses to be treated must measure \< 30 mL on the contrast-enhanced diagnostic MRI brain scan obtained within 21 days prior to randomization * "last SRS" refers to the most recent SRS procedure that the patient received prior to enrollment on this study * Distant brain relapse lesions must be diagnosed on MRI, which will include the following elements: * REQUIRED MRI ELEMENTS * Post gadolinium contrast-enhanced T1-weighted three-dimensional (3D) spoiled gradient (SPGR). Acceptable 3D SPGR sequences include magnetization-prepared 3D gradient recalled echo (GRE) rapid gradient echo (MP-RAGE), turbo field echo (TFE) MRI, BRAVO (brain volume imaging) or 3D fast FE (field echo). The T1-weighted 3D scan should use the smallest possible axial slice thickness, not to exceed 1.5 mm * Pre-contrast T1 weighted imaging (3D imaging sequence strongly encouraged) * A minimum of one axial T2 fluid attenuated inversion recovery (FLAIR) (preferred) or T2 sequence is required. This can be acquired as a 2D or 3D image. If 2D, the images should be obtained in the axial plane * ADDITIONAL RECOMMENDATIONS * Recommendation is that an axial T2 FLAIR (preferred) sequence be performed instead of a T2 sequence * Recommendation is that that pre-contrast 3D T1 be performed with the same parameters as the post-contrast 3D T1 * Recommendation is that imaging be performed on a 3 Tesla (3T) MRI * Recommendation is that the study participants be scanned on the same MRI instrument at each time point * Recommendation is that if additional sequences are obtained, these should meet the criteria outlined in Kaufmann et al., 2020 * If additional sequences are obtained, total imaging time should not exceed 60 minutes * Brain metastasis velocity (BMV) since last SRS must be \>= 4 brain metastases/year * The patient or a legally authorized representative must provide study-specific informed consent prior to study entry * Pathologically (histologically or cytologically) proven diagnosis of small cell cancer, non-small cell lung cancer, melanoma, breast cancer, renal cell carcinoma, or gastrointestinal cancer within 10 years prior to randomization. If the original histologic proof of malignancy is greater than 10 years, then pathological (i.e., more recent) confirmation is required (e.g., from a systemic metastasis or brain metastasis) * Other histologies are not permitted * History and physical examination within 28 days prior to randomization * Age \>= 18 * Karnofsky performance status of \>= 70 within 28 days prior to randomization * Calculated creatinine clearance (CrCl) \>= 30 ml/min (within 28 days prior to randomization) * Blood urea nitrogen (BUN) within 1.5 times the institutional upper limit of normal (ULN) (e.g., if the ULN is 20 mg/dL, then BUN up to 30 mg/dL is permitted) (within 28 days prior to randomization) * Negative urine or serum pregnancy test (in women of childbearing potential) within 14 days prior to randomization Exclusion Criteria: * BMV \>= 4 brain metastases/year at time of any SRS prior to enrollment. * Patients are permitted to have undergone multiple SRS treatments to different brain metastases so long as prior BMV has been less than 4 brain metastases/year * Prior WBRT or prophylactic cranial irradiation * Local relapse of metastasis previously treated with upfront SRS (i.e., relapse outside previously SRS-treated metastases is allowed) * Brain metastases from primary germ cell tumor or lymphoma * Definitive leptomeningeal metastasis * Planned cytotoxic chemotherapy on the same day as SRS or HA-WBRT; concurrent immunotherapy is permitted * Radiographic evidence of enlargement or other architectural distortion of the lateral ventricles, including placement of external ventricular drain or ventriculoperitoneal shunt * Known history of demyelinating disease such as multiple sclerosis * Inability to swallow pills * Contraindication to MR imaging such as non-MR conditional implanted metal devices or unknown metallic foreign bodies, or contraindication to gadolinium contrast administration during MR imaging, such as anaphylactic allergy that cannot be adequately addressed with pre-contrast medications or acute kidney injury * Contraindications to memantine, including: * Allergy, including prior allergic reaction to memantine * Intractable seizures on adequate anticonvulsive therapy-more than 1 seizure per month for the past 2 months * Current use of N-methyl-D-asparatate (NMDA) agonist * Current alcohol or drug abuse, which can exacerbate lethargy/dizziness with memantine * Severe, active co-morbidity defined as follows: * Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months * Transmural myocardial infarction within the last 6 months * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of randomization * Chronic obstructive pulmonary disease exacerbation or other acute respiratory illness precluding study therapy at the time of randomization * Severe hepatic disease defined as a diagnosis of Child-Pugh class B or C hepatic disease * Renal tubular acidosis or metabolic acidosis * Human immunodeficiency virus (HIV) positive with CD4 count \< 200 cells/microliter. Note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count \>= 200 cells/microliter within 30 days prior to randomization. Note also that HIV testing is not required for eligibility for this protocol * Pregnant or lactating women, or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the medication and radiation involved in this study has unknown effects on the unborn fetus
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Banner University Medical Center - Tucson
Tucson, Arizona, 85719, United States
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CHUM - Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2X 3E4, Canada
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California Pacific Medical Center-Pacific Campus
San Francisco, California, 94115, United States
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Carle Cancer Center
Urbana, Illinois, 61801, United States
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Carle Physician Group-Effingham
Effingham, Illinois, 62401, United States
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Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938, United States
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Carle at The Riverfront
Danville, Illinois, 61832, United States
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Central Maryland Radiation Oncology in Howard County
Columbia, Maryland, 21044, United States
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Chelsea Hospital
Chelsea, Michigan, 48118, United States
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Christiana Care Health System-Christiana Hospital
Newark, Delaware, 19718, United States
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Christiana Care Health System-Concord Health Center
Chadds Ford, Pennsylvania, 19317, United States
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City of Hope Antelope Valley
Lancaster, California, 93534, United States
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City of Hope Comprehensive Cancer Center
Duarte, California, 91010, United States
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City of Hope Corona
Corona, California, 92882, United States
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City of Hope South Bay
Torrance, California, 90503, United States
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City of Hope South Pasadena
South Pasadena, California, 91030, United States
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City of Hope Upland
Upland, California, 91786, United States
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City of Hope at Irvine Lennar
Irvine, California, 92618, United States
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Covenant Medical Center-Lakeside
Lubbock, Texas, 79410, United States
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Delaware Clinical and Laboratory Physicians PA
Newark, Delaware, 19713, United States
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Drexel Town Square Health Center
Oak Creek, Wisconsin, 53154, United States
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Froedtert Menomonee Falls Hospital
Menomonee Falls, Wisconsin, 53051, United States
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Froedtert West Bend Hospital/Kraemer Cancer Center
West Bend, Wisconsin, 53095, United States
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Geisinger Cancer Services-Pottsville
Pottsville, Pennsylvania, 17901, United States
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Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
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Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania, 17837, United States
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Helen F Graham Cancer Center
Newark, Delaware, 19713, United States
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Lankenau Medical Center
Wynnewood, Pennsylvania, 19096, United States
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Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980, United States
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MedStar Franklin Square Medical Center/Weinberg Cancer Institute
Baltimore, Maryland, 21237, United States
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Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
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Medical Oncology Hematology Consultants PA
Newark, Delaware, 19713, United States
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Medical University of South Carolina
Charleston, South Carolina, 29425, United States
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Memorial Hospital West
Pembroke Pines, Florida, 33028, United States
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Northwell Health/Center for Advanced Medicine
Lake Success, New York, 11042, United States
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Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, 60134, United States
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Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois, 60115, United States
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Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, 60555, United States
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Northwestern University
Chicago, Illinois, 60611, United States
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Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
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Pamela Youde Nethersole Eastern Hospital
Chai Wan, Hong Kong
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Prisma Health Cancer Institute - Faris
Greenville, South Carolina, 29605, United States
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Riddle Memorial Hospital
Media, Pennsylvania, 19063, United States
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Rush University Medical Center
Chicago, Illinois, 60612, United States
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Sanford Bismarck Medical Center
Bismarck, North Dakota, 58501, United States
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Sanford Broadway Medical Center
Fargo, North Dakota, 58122, United States
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Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122, United States
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Siteman Cancer Center at Christian Hospital
St Louis, Missouri, 63136, United States
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Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, 63376, United States
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Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, 63141, United States
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Siteman Cancer Center-South County
St Louis, Missouri, 63129, United States
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State University of New York Upstate Medical University
Syracuse, New York, 13210, United States
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Sutter Cancer Centers Radiation Oncology Services-Roseville
Roseville, California, 95661, United States
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Sutter Medical Center Sacramento
Sacramento, California, 95816, United States
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Sutter Roseville Medical Center
Roseville, California, 95661, United States
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The Carle Foundation Hospital
Urbana, Illinois, 61801, United States
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Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, 48114, United States
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Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan, 48118, United States
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Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan, 48197, United States
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Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, 48106, United States
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Tufts Medical Center
Boston, Massachusetts, 02111, United States
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UM Baltimore Washington Medical Center/Tate Cancer Center
Glen Burnie, Maryland, 21061, United States
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UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida, 33146, United States
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UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, 33442, United States
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UM Upper Chesapeake Medical Center
Bel Air, Maryland, 21014, United States
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UPMC Cancer Centers - Arnold Palmer Pavilion
Greensburg, Pennsylvania, 15601, United States
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UPMC Memorial
York, Pennsylvania, 17408, United States
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UPMC-Shadyside Hospital
Pittsburgh, Pennsylvania, 15232, United States
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University of Arizona Cancer Center-North Campus
Tucson, Arizona, 85719, United States
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University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637, United States
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University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201, United States
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University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136, United States
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University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
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University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
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University of Rochester
Rochester, New York, 14642, United States
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University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, 53792, United States
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Upstate Cancer Center at Verona
Verona, New York, 13478, United States
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Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298, United States
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Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
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Washington University School of Medicine
St Louis, Missouri, 63110, United States
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West Virginia University Healthcare
Morgantown, West Virginia, 26506, United States
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