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NCT Number: NCT07802353

A Study of Stereotactic Radiosurgery (SRS) in People With Brain Cancer Having Tumor Resection Surgery

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.

Recruiting

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Stereotactic Radiosurgery

Radiation

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

Procedure

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 outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Luke Pike, MD, PhD

CONTACT

[email protected]

212-639-8157

Nelson Moss, MD

CONTACT

212-639-7075

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

PReoperative Dose Escalated Stereotactic radioSurgery for Resectable Brain Metastases (PRESS)

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 3, 2026
Registry last updated
Sep 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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