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New approach: radiation first, then surgery for brain tumors
NCT ID NCT04545814
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This pilot study tested whether giving gamma knife radiation before surgery for brain metastases is safe and feasible. Eleven adults with 1 to 4 brain tumors took part. The goal was to see how many patients could have surgery after radiation and how many had no visible tumor left on MRI afterward.
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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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11 people
The number who actually took part.
- Started
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Jan 2021
- Finished
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Aug 2024
- 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. Voluntary written consent must be given before performance of any study related procedure that's is not part of standard medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care. 2. Female or Male subject's ≥ 18 years old at the time of informed consent. 3. Radiographically confirmed solid tumor brain metastases. 4. Criteria for surgical resection of at least one metastasis per neurosurgeon discretion. 5. Stereotactic radiosurgery candidate per radiation oncologist discretion. 6. A diagnostic MRI Brain or CT Head demonstrating the presence of 1-4 solid tumor brain metastases and lesion to be resected no more than 5 cm in any direction, performed within 30 days prior to stereotactic radiosurgery. 7. For known and unknown primary, diagnosis-specific graded prognostic assessment (ds-GPA) estimated median survival no less than 6 months. 8. Surgical resection able to be performed within 1-10 days after radiosurgery. 9. Patients currently on cytotoxic chemotherapy or immunotherapy are eligible, not including anti-vascular endothelial growth factor (anti-VEGF) therapy. 10. Female subjects who: 1. Are postmenopausal for at least 1 year before the screening visit, OR 2. Are surgically sterile, OR i. Agree to practice 1 highly effective method and 1 additional effective (barrier) method of contraception, at the same time, from the time of signing the informed consent through 4 months after the last study Intervention (female and male condoms should not be used together), OR ii. Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence \[eg, calendar, ovulation, symptothermal, post-ovulation methods\] withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception.) 11. Male subjects, even if surgically sterilized (ie, status post-vasectomy), who: 1. Agree to practice effective barrier contraception during the entire study treatment period from the time of signing the informed consent through and through 4 months after the last study Intervention (female and male condoms should not be used together), OR 2. Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence \[eg, calendar, ovulation, symptothermal, post-ovulation methods for the female partner\] withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception.) Exclusion Criteria: 1. Patients who received anti-VEGF therapy within 6 weeks prior to enrollment, as there is increased risk of fatal brain hemorrhage with surgical resection. 2. Major medical illnesses or psychiatric impairments, which in the investigator's opinion will prevent administration or completion of the protocol therapy and/or interfere with surveillance. 3. Patients with more than 4 brain metastases on MRI Brain. 4. Lesion to be resected is more than 5 cm in any dimension. 5. Patients with leptomeningeal metastases documented by MRI or cerebrospinal fluid (CSF) evaluation. 6. Previous whole brain radiation therapy. 7. Previous radiation therapy to the lesion to be resected. 8. Planned adjuvant focal therapy including additional radiation therapy to the brain. 9. Not a surgical candidate per neurosurgeon discretion. 10. Not a stereotactic radiosurgery candidate per radiation oncologist discretion. 11. Surgery unable to be performed between 1 - 10 days after radiosurgery. 12. Women who are pregnant or nursing as treatment involves unforeseeable risks to the fetus or child. 13. Patients who have a known or unknown primary and have an estimated median survival of less than 6 months per ds-GPA.
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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.
Contacts and locations
Locations
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Froedtert Hospital & Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can doctors watch brain metastases instead of zapping them?
- Starving brain tumors of blood before surgery
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- A sharper MRI could reveal radiation sensitivity of brain tumors
- Expert tumor board may extend survival in brain metastases