New trial aims to improve radiation for large brain tumors
NCT ID NCT07227610
First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 1 time
Summary
This phase 2 trial compares two standard radiation approaches for people with large brain metastases (tumors that spread from other cancers). One method gives two radiation doses a month apart; the other gives three daily doses. The study will track tumor control, side effects, and quality of life in 54 participants to see which approach works better.
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 (staged stereotactic radiosurgery or fractionated stereotactic radiotherapy)
- What this could lead to
- If successful, this trial could identify which radiation schedule better controls large brain tumors while reducing the need for steroids or additional procedures.
- What could go wrong
- This is a small, early-phase study (54 participants) comparing two existing treatments, so it may not show a clear winner. Risks include radiation necrosis and tumor progression.
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 54 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Jan 2032
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: 1. The patient or a legally authorized representative must be able and willing to provide study-specific informed consent prior to study entry. 2. Patient must be willing to comply with all study procedures and available for the duration of the study 3. Male or female, aged ≥ 18 years 4. Karnofsky Performance Status (KPS) ≥ 60 within 7 days prior to registration 5. Radiographic confirmation of brain metastasis measuring ≥2 cm and ≤ 5 cm in maximum diameter 1. Multiple metastases are allowed. Additional metastases will be treated with single fraction SRS as per standard of care. Up to 10 additional smaller metastases are allowed on protocol. All additional smaller metastases must be less than 2 cm. 2. If a patient has more than one large metastasis (measuring between 2 and 5 cm as above), up to two can be treated on study protocol 3. All tumors must be ≥ 5mm from the optic chiasm and optic nerves. 6. Known active or history of invasive non-CNS primary cancer based on documented pathologic diagnosis within the past 3 years 7. Patient is able to medically tolerate SRS 8. Patient is neurologically stable (immediate surgery not necessary or not recommended) 9. A negative urine or serum pregnancy test (in persons of childbearing potential) within 7 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. 10. Women who are sexually active must agree to use medically acceptable forms of contraception during treatment on this study to prevent pregnancy. Exclusion Criteria: 1. Prior cranial radiotherapy, including whole brain radiotherapy (WBRT), or SRS in the area of the large metastasis to be treated on study. 2. Evidence of leptomeningeal disease (LMD) Note: For the purposes of exclusion, LMD is a clinical diagnosis, defined as positive 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 such cases, CSF sampling is not required to formally exclude LMD, but can be performed at the investigator's discretion based on level of clinical suspicion. 3. Inability to undergo MRI with contrast 4. Planned administration of systemic therapy (chemotherapy or immunotherapy) within 3 days prior to, the day of, or 3 days after completion of SRS.
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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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Medical University of South Carolina Hollings Cancer Center
RECRUITINGCharleston, South Carolina, 29425, United States
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Other studies related to the condition(s) this trial covers.
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