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Radiation Therapy for Brain Metastases

This study is comparing two types of radiation therapy for cancer that has spread to the brain. It's looking at whether fractionated stereotactic radiosurgery (FSRS), which delivers radiation over three treatments, is more effective than usual stereotactic radiosurgery (SRS), which uses a single large dose. Both FSRS and SRS use high-energy X-rays to kill cancer cells. The study aims to see if FSRS can better prevent the cancer from growing back in the treated area. You might be able to join if you have certain types of cancer, like breast, lung, or gastrointestinal cancer, that have spread to your brain. The study will enroll about 269 people.

Study design
This is an interventional study comparing two types of radiation therapy. It plans to enroll 269 participants.
What's involved
Participants will undergo either SRS (one treatment) or FSRS (three treatments). You will also have CT and MRI scans.
Compensation
Not stated in the trial record.
Follow-up
Your progress will be assessed for up to 5 years to see if the cancer returns in the treated area.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06500455

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
NRG Oncology
~269 participants
Updated 2026-08-17 on ClinicalTrials.gov
What's tested:Computed TomographyFractionated Stereotactic Radiation TherapyMagnetic Resonance ImagingStereotactic Radiosurgery

At a glance

Recruiting sites
263 of 270 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time to local failure
Measured over 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

Conditions

Anatomic Stage IV Breast Cancer AJCC v8
Metastatic Breast Carcinoma
Metastatic Digestive System Carcinoma
Metastatic Lung Non-Small Cell Carcinoma
Metastatic Malignant Neoplasm in the Brain
Metastatic Malignant Solid Neoplasm
Metastatic Melanoma
Metastatic Renal Cell Carcinoma
Stage IV Lung Cancer AJCC v8
Stage IV Renal Cell Cancer AJCC v8

Explore related trials

Breast CarcinomaLung Non-Small Cell CarcinomaMalignant Digestive System NeoplasmMelanomaRenal Cell CarcinomaSolid Neoplasm

Where it's being run

270 sites across 43 states
Illinois24
New York24
California21
Pennsylvania17
New Jersey14
Florida13
Ohio13
Michigan12

Study leadership

  • Rupesh R Kotecha · PRINCIPAL_INVESTIGATOR · NRG Oncology

Who to contact

Site Public Contact
[email protected]
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

What this trial measures

  • Time to local failureFrom 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.