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Brain metastases trial tests skipping radiation when drugs work
NCT ID NCT06974370
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This study tests whether people with brain metastases from solid tumors can avoid radiation therapy if their brain tumors shrink or stay stable with systemic treatments like immunotherapy, targeted therapy, or chemotherapy. About 45 participants will be monitored with regular brain scans, and radiation is only used if tumors progress. The goal is to see if this approach is feasible and improves quality of life.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- systemic therapy (immunotherapy, targeted therapy, or chemotherapy)
- What this could lead to
- If successful, this could show that many patients with brain metastases can avoid radiation and its side effects, relying on systemic therapy alone for control.
- What could go wrong
- This is a small pilot study (45 people) and early results may not apply to all patients. Some participants may still need radiation if their brain tumors grow despite systemic therapy.
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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 45 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2025
- Expected to finish
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Dec 2030
An estimate. End dates often move.
- 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: Pathologically (histologically or cytologically) proven diagnosis of a solid tumor malignancies within 5 years prior to registration. 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, PET/CT, etc.) is required. These scans are considered standard-of-care (SOC) and will not be ordered for research purposes. Initiation or planning for initiation of systemic therapy to include one or more of the following categories expected to cause an intracranial response: * Brain penetrant targeted therapies (e.g. tyrosine kinase inhibitors, multikinase inhibitors, EGFR inhibitor, ALK inhibitor, BRAF/MEK inhibitor) * Checkpoint inhibitor immunotherapy (e.g. PDL-1 inhibitors, PD1 inhibitors, CTLA-4 inhibitors) * HER2 antibody-drug conjugate (e.g. TDM1, TDX-D) * Anti-Hormone therapies for Breast Cancer * Cytotoxic chemotherapy alone may be started initially, but with plan for immunotherapy or eligible targeted therapy noted above before the re-evaluation MRI head At least 1 brain metastasis that not planned for radiation therapy or surgery. All brain metastases not planned for resection much be ≤3 cm, with no minimum size required. Systemic therapy has started within 4 weeks of MRI brain showing new or progressive disease or plan to start systemic therapy within 4 weeks of MRI brain showing new or progressive disease. Ability to obtain MRI head scans with contrast. All MRI head scans must have slice thickness ≤1.5 mm. Age ≥ 18 years KPS \>60 Ability to understand and the willingness to sign a written informed consent. Exclusion Criteria: No use of the planned new systemic therapy meeting 2.1.2 criteria to address brain metastases within the last 6 months. Prior radiotherapy to the active brain metastases (partial or whole brain irradiation, or prophylactic cranial irradiation \[PCI\]) Patients pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants. Negative urine 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. Serious medical comorbidities that in the opinion of the investigator would prevent participation in this study. Known leptomeningeal disease (LMD) \-
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Vermont Medical Center
RECRUITINGBurlington, Vermont, 05401, United States
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