SRS Before Surgery for Brain Metastases to Try Better Surgical Outcomes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers will target the index brain metastasis with stereotactic radiosurgery, then perform surgical resection of that tumor. The study focuses on patients with brain metastases from various cancers who are planned for resection of one lesion that has not previously received focal radiotherapy. Only the treated tumor is removed in the protocol; other lesions may receive standard radiation if clinically indicated. The goal is to see if preoperative SRS lowers risk of cancer cells spreading during surgery and decreases post-surgical complications. Pathologic examination of the resected lesion is required, and prior SRS to non-index lesions is allowed with study oversight.

Why it matters

Who can join: the full rules

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.

Where it's running

• Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
  Basking Ridge, New Jersey, United States Recruiting
• Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
  Middletown, New Jersey, United States Recruiting
• Memorial Sloan Kettering Bergen (Limited Protocol Activities)
  Montvale, New Jersey, United States Recruiting
• Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
  Commack, New York, United States Recruiting
• Memorial Sloan Kettering Westchester (Limited Protocol Activities)
  Harrison, New York, United States Recruiting
• Memorial Sloan Kettering Cancer Center (All Protocol Activities)
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Luke Pike, MD, PhD — Memorial Sloan Kettering Cancer Center
• Study coordinator: Luke Pike, MD, PhD
• Email: pikel@mskcc.org
• Phone: 212-639-8157

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.