Tiny margin, big difference? new trial tests radiation precision for brain tumors
NCT ID NCT06857006
First seen Jun 27, 2026 · Last updated Jul 31, 2026 · Updated 2 times
Summary
This study tests whether using a 0mm or 2mm margin around brain metastases during radiosurgery leads to better tumor control with fewer side effects. Radiosurgery delivers a high dose of radiation to kill tumors. The trial will enroll 180 adults with brain metastases up to 4 cm in size. By comparing the two margin sizes, researchers hope to find the best balance between killing cancer and protecting healthy brain tissue.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Radiosurgery (focused radiation to kill tumors)
- What this could lead to
- If successful, this could show that a smaller radiation margin (0mm) works just as well as a larger one (2mm) for controlling brain metastases, potentially reducing side effects.
- What could go wrong
- This is a phase 2 trial with 180 participants, so results are still preliminary. The optimal margin may depend on tumor size or location, and individual outcomes may vary.
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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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 180 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2025
- Expected to finish
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Aug 2028
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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19 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: 1. Stated willingness to comply with all study procedures and availability for the duration of the study 2. Male or female, aged 19 and older 3. Brain metastases diagnosis not requiring retreatment to the same tumor 4. For females of reproductive potential should undergo pregnancy testing as per UAB Radiation Oncology standard policies 5. Ability of subject or Legally Authorized Representative (LAR)) to understand and the willingness to sign a written informed consent document. Exclusion Criteria: 1. Current use of cytotoxic chemotherapy within 3 days of treatment. There are no restrictions on the use of immunotherapy during treatment. TKIs known to be radiation sensitizers such as BRAF should be held at least 24 hours prior to treatment. 2. Inability to have MRI imaging 3. Pregnancy 4. Treatment with another investigational drug 14 days of enrollment 5. Radiosurgery planned for post-operative adjuvant cavity only. Patients with any gross residual after surgery are eligible. Patients with at least one intact metastasis may enroll but adjuvant cavity will not be evaluable. 6. At the time of Radiation Oncology consultation more than twenty targets are identified. Note that it is common that a few additional metastases may be identified during the treatment planning or peer review processes. More than twenty targets may be included if this number is found after the initial clinical review of the treatment planning MRI. 7. Tumor maximal diameter \> 4 cm. 8. Prior SBRT or SRS to a lesion planned for retreatment. Note that patients with prior whole brain radiation alone are eligible. 9. Patients with diffuse leptomeningeal tumor are not eligible. Patients with a focal dural or pachymeningeal tumor are eligible if other intra-axial tumors are planned to be treated. Similar to postoperative cavities, the pachymeningeal tumor deposit will be treated but not evaluable for the assessment of local control or toxicity. INCLUSION OF VULNERABLE PARTICIPANTS Vulnerable populations as defined by the NIH including children, prisoners, and adult subjects who lack capacity to consent to research participation are not eligible.
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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 Alabama at Birmingham (UAB) Hazelrig-Salter Radiation Oncology Center
RECRUITINGBirmingham, Alabama, 35249, United States
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Other studies related to the condition(s) this trial covers.
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