New study tests if delaying radiation improves brain tumor control
NCT ID NCT06649058
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial is testing whether giving systemic therapy first, followed by focused radiation (stereotactic radiosurgery), can better control brain metastases. About 316 adults with brain metastases that are low-risk will receive standard cancer drugs, then some will get radiation to all or only growing tumors. The goal is to see if this sequence improves disease control and safety.
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 (standard cancer drugs) and stereotactic radiosurgery (focused radiation)
- What this could lead to
- If successful, this could show that adding focused radiation after initial drug therapy improves control of brain metastases and delays disease progression.
- What could go wrong
- This is a mid-stage trial with 316 participants, so results are not yet proven. The benefit may be small or limited to certain patients, and radiation carries risks like brain swelling or damage.
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 316 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2025
- Expected to finish
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Sep 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: 1. Age ≥ 18 years. 2. Evaluation by a brain metastasis multidisciplinary team (BM-MDT) consisting of a medical oncologist (can be the patient's primary medical oncologist), a radiation oncologist who regularly performs SRS, and a neurosurgeon. This evaluation can take place in clinic or during a multidisciplinary conference. 3. Life expectancy \> 6 months as estimated by BM-MDT. 4. BM-MDT agreement that the planned systemic therapy regimen may provide intracranial benefit (SD, PR, or CR in the CNS). 5. BM-MDT agreement that the patient's BM does not require immediate local therapy (surgery and/or radiation therapy); i.e. it is judged to be safe to omit local therapy as initial BM management. 6. The patient's BM are amenable to SRS as initial local therapy as determined by BM-MDT. 7. Subjects must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol-related procedures that are not part of normal subject care. 8. Histologically confirmed metastatic cancer with at least one measurable metastasis in the brain (≥ 5 mm). 9. At least one measurable intracranial target lesion which was not previously treated with SRS. Regrowth in a cavity of previously excised lesion will not qualify as a measurable lesion. Growth or change in a lesion previously irradiated will not qualify as a measurable lesion. 10. Prior SRS and prior excision of BM is permitted if other measurable non irradiated lesions as described in #9 remain. 11. The resection cavity of excised BM must have received appropriate radiation therapy (pre or post operative SRS, brachytherapy) or have been observed for \>6 months after resection without evidence of local cavity recurrence. 12. Subjects must be free of neurologic signs and symptoms related to metastatic brain lesions either without systemic corticosteroids or requiring ≤ 2 mg dexamethasone daily for symptom resolution. 13. ECOG performance status ≤ 1. 14. Documented agreement by the patient's primary medical oncologist with the appropriateness of planned SST regimen. 15. This study will allow non-English speaking subjects to be enrolled. Verbal Translation Preparative Sheet (VTPS) will be used if a translated consent form is not available in the subject's language. The consent form will be translated into the language of the subject after 2 or more occurrences. This will apply to any MD Anderson patient. Exclusion Criteria: 1. History of known leptomeningeal involvement (radiographic or cytological). 2. Small cell lung cancer, lymphoma, or leukemia histology. 3. Non-small cell lung cancer histology with targetable oncogenic driver mutation with planned initiation of highly CNS active targeted therapy (eg osimertinib, brigatinib, alectinib, or lorlatinib). 4. Subjects previously treated with WBRT. 5. Any intact BM size \> 3 cm. After surgical excision and appropriate radiation therapy to the cavity, patients may enroll if additional eligible lesions are present. 6. Prior disease progression on one or more of the agents comprising SST. 7. Exposure to one or more agents comprising SST within the last 30 days. 8. Prior unacceptable toxicity during treatment with one or more agents comprising SST. 9. Subjects with a major medical, neurologic or psychiatric condition who are judged as unable to fully comply with study therapy or assessments should not be enrolled. 10. History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years. Note: The time requirement does not apply to participants who underwent successful treatment of superficial bladder cancer, in situ cervical cancer, ductal carcinoma in situ, or other in-situ cancers. Subjects with a completely treated prior malignancy and no evidence of disease for ≥ 2 years are eligible. 11. Skin Cancer Exclusion: Please note that localized cutaneous basal cell carcinoma and squamous cell carcinoma is not an exclusion criterion regardless of treatment status. Biopsy proven metastatic disease from these histologies is an exclusion criterion if this constitutes a second cancer. 12. Patient weight \>450 pounds. 13. Patient had prior SRS to any intracranial lesion \<15mm from a metastasis on the screening MRI. Prior MRIs and DICOMs will be used to make this determination. 14. Patient unable to receive a brain MRI (implanted metal devices or foreign bodies) or MRI contrast. 15. Any BM with a significant hemorrhagic component (defined as MRI T1 intrinsic hyperintensity comprising ≥ 25% of maximal lesion diameter).
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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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The University of Texas MD Anderson Cancer Center
RECRUITINGHouston, Texas, 77030, United States
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Other studies related to the condition(s) this trial covers.
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