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RECRUITING Phase 1 / Phase 2 ClinicalTrials.gov

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

Sponsor: Case Comprehensive Cancer Center • ClinicalTrials.gov ID: NCT01891318

Registry updated: 2026-10-09
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Description

This Phase I/II trial studies the ability to stop brain metastases from coming back after treatment with radiosurgery followed by surgical resection. It will also evaluate the side effects of these combined treatments and help determine the best radiosurgery dose. Radiosurgery focuses the x-rays directly to the tumor and cause less damage to the normal tissue in the brain.

Interventions

  • radiosurgery (Radiation)
    Undergo radiosurgery
  • therapeutic conventional surgery (Procedure)
    Undergo surgical resection
  • quality-of-life assessment (Procedure)
    Ancillary studies

Eligibility criteria

Inclusion Criteria: * 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 Criteria: * 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

Conditions

Tumors Metastatic to Brain

Locations

  • University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center — Cleveland, Ohio, United States
  • Cleveland Clinic, Case Comprehensive Cancer Center — Cleveland, Ohio, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record