Neoadjuvant Radiosurgery for Resectable Brain Metastases

This study is looking at a new way to treat brain metastases (cancers that have spread to the brain) by using radiosurgery (a type of radiation therapy that precisely targets tumors) before surgical removal. The main goal is to see how safe this combined treatment is and to find the best dose of radiosurgery. Researchers also want to know how well this approach prevents brain metastases from growing back. You might be able to join if you are 18 or older, have a specific type of cancer (not small cell lung cancer, lymphoma, or germ cell tumors), and have 1-4 brain metastases that can be treated with both radiosurgery and surgery. The study is currently unclear on its recruitment status.

Study design
This is a Phase I/II study with a planned enrollment of 36 participants. It starts with a Phase I to find the safest dose of radiosurgery, followed by a Phase II to see how well it works.
What's involved
Participants will undergo radiosurgery and surgical resection. They will also have quality-of-life assessments.
Compensation
Not stated in the trial record.
Follow-up
The study will follow participants for up to 3 years to see if the brain metastases return.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT01891318

Neoadjuvant Radiosurgery for Resectable Brain Metastases: Phase I/II Study

Recruiting
PHASE1Ages 18+InterventionalTreatment
Case Comprehensive Cancer Center
~36 participants
Updated 2026-08-06 on ClinicalTrials.gov
What's tested:radiosurgerytherapeutic conventional surgeryquality-of-life assessment

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum tolerated dose (MTD)
Measured over Day 0
+1 more outcome measured
Tumors Metastatic to Brain
2 sites across 1 states
Ohio2
  • Erin Murphy, MD · PRINCIPAL_INVESTIGATOR · Case Comprehensive Cancer Center

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Eligibility criteria

Inclusion

Have a prior histologic diagnosis of cancer other than small cell lung cancer, lymphoma, and germ cell histologies
Magnetic resonance imaging (MRI) evidence of 1-4 brain metastases, with at least one lesion \> 20 mm and ≤ 50 mm in maximal diameter and determined to be appropriate for SRS and gross total resection; all other brain metastases are appropriate for SRS
Patient can have prior SRS to lesions other than the one planned for neoadjuvant SRS and resection
Patient must have a Karnofsky performance score of ≥ 70

Exclusion

Patient deemed medically unfit to undergo surgical resection of brain metastasis
Prior whole brain radiotherapy
Patient with contraindication for imaging with MRI
Inability to participate in study activities due to physical or mental limitations
Inability or unwillingness to return for all the required follow-up visits
At the time of planning, unable to deliver 10 Gray (Gy) or less to optic nerve/chiasm
Tumor located in the brainstem
Imaging or cytologic evidence of leptomeningeal disease
  • Maximum tolerated dose (MTD)Day 0

    MTD of radiosurgery determined by dose-limiting toxicities graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0 (Phase I)

  • Proportion of participants without local failure (Phase II)Up to 3 years

    Local control of brain metastases, as measured by proportion of participants without local failure (Local failure is tumor progression of the metastasis treated on the study) (Phase II) The Kaplan-Meier method will be used.