Recruiting

Stereotactic Radiosurgery

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT07802353

Conditions

Brain Metastasases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Stereotactic Radiosurgery

Surgical Resection

Study Details

Brief summary:

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.

Conditions

Brain Metastasases

Study ID

NCT07802353

Start date

Aug 28, 2026

Status verified date

Sep, 2026

Completion date

Aug, 2028

Anticipated

Primary completion date

Aug, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.
  • Age ≥ 18
  • 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.

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Stereotactic RadioSurgery

Patients will be seen by an attending radiation oncologist before receiving SRS. Standard of are history and physical will be obtained. An MRI brain with contrast will be performed within seven days of the CT simulation for SRS planning. Surgical resection of the index lesion is to be performed within 10 days of SRS, and no later than 21 days to accommodate operating room availability.

Interventions

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.

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 measure

  • local failure [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Luke Pike, MD, PhD

212-639-8157pikel@mskcc.org

Nelson Moss, MD

212-639-7075

Locations

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Luke Pike, MD

212-639-8157

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Luke Pike, MD

212-639-8157

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Luke Pike, MD

212-639-8157

Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)

Recruiting

Commack, New York, United States, 11725

Contacts

Luke Pike, MD

212-639-8157

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Recruiting

Harrison, New York, United States, 10604

Contacts

Luke Pike, MD

201-775-7604

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

Recruiting

New York, New York, United States, 10065

Contacts

Luke Pike, MD

201-775-7604

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Recruiting

Rockville Centre, New York, United States, 11553

Contacts

Luke Pike, MD

212-639-8157

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Sep 9, 2026

Last verified

Sep, 2026

Keywords

  • Escalated Stereotactic radioSurgery
  • 26-304

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-09-09.