NCT07802353 · Memorial Sloan Kettering Cancer Center
A Study of Stereotactic Radiosurgery (SRS) in People With Brain Cancer Having Tumor Resection Surgery
What this study is about
The researchers are doing this study to see if treating people's brain tumors with stereotactic radiosurgery (SRS) before tumor resection surgery will prevent cancer cells from spreading to other areas of the brain, including the fluid and lining around the brain, during surgery, and lead to better surgical outcomes and fewer complications after surgery (post-surgery complications).
View original scientific description
The researchers are doing this study to see if treating people's brain tumors with stereotactic radiosurgery (SRS) before tumor resection surgery will prevent cancer cells from spreading to other areas of the brain, including the fluid and lining around the brain, during surgery, and lead to better surgical outcomes and fewer complications after surgery (post-surgery complications). Only one brain tumor (the index tumor) will be treated with the study radiosurgery and then removed by surgery. If there are other brain tumors, they will not be removed by surgery in this study, although they may be treated separately with standard radiation if the doctor decides it is needed.
Interventions
RADIATION
Stereotactic Radiosurgery
Stereotactic Radiosurgery (SRS) to the index lesion will be delivered with standard of care technique at doses of 18Gy or 21Gy, for tumors \>3cm and ≤3cm, respectively, in a single fraction.
PROCEDURE
Surgical Resection
Patients will undergo standard-of-care surgical resection of the index lesion within 10 days of SRS, and no later than 21 days to accommodate operating room availability.
Primary outcome measures
local failure, pachymeningeal disease, classical leptomeningeal disease, symptomatic radiation necrosis, or death from any cause.
Time frame: 1 year
to a composite adverse endpoint that includes This endpoint will be measured from date of receipt of SRS. These events are combined because they represent the totality of clinically meaningful central nervous system failure after resection and adjuvant radiation, are competing and partly related processes, and individually occur too infrequently to power a single-arm study.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Histologically or cytologically confirmed breast cancer, non-small cell lung cancer, melanoma, or gastrointestinal cancer. In malignancies for which tissue confirmation is not standard diagnostic practice (for example, hepatocellular carcinoma diagnosed by characteristic imaging), radiographic diagnosis consistent with standard of care is acceptable. In all cases, the intracranial lesion planned for resection undergoes pathologic examination as part of protocol-directed surgery.
- At least one intact brain metastasis is planned for surgical resection that has not previously received stereotactic radiosurgery or other focal radiotherapy, measuring 6 cm or less in diameter.
- No evidence of leptomeningeal disease based on clinical symptoms, MRI imaging of the brain or spinal cord, and/or lumbar puncture cytologic analysis.
- No prior SRS to the index BM planned for surgical resection. Prior SRS to non- index lesions is permitted, with approval from the principal investigator. The interval since prior cranial radiotherapy will be recorded. All clinically significant toxicities from prior radiotherapy must have resolved to grade 1 or lower (CTCAE); patients with unresolved symptomatic (grade 2 or higher) radiation necrosis, treatment-related enhancing treatment effect, or clinically significant cerebral edema attributable to prior cranial radiation are not eligible.
- No prior therapeutic craniotomy or craniectomy with biopsy.
- Karnofsky Performance Status (KPS) of ≥ 70 and anticipated survival of \>1 year
- Ability to undergo contrast-enhanced MRI brain
Exclusion criteria
- Pregnant and/or breastfeeding
- Prior whole brain radiotherapy.
- Neurologic instability despite medical management, such that either the treating team or study investigators feel that urgent craniotomy without awaiting SRS is indicated.
- Judgment by the principal investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements.
Where
- Basking Ridge, New Jersey
- Middletown, New Jersey
- Montvale, New Jersey
- Commack, New York
- East White Plains, New York
- New York, New York
- Rockville Centre, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 3, 2026 · Source of record for eligibility and locations