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

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.

Conditions

Tumors Metastatic to Brain

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Tumors Metastatic to Brain
Intervention / Treatment

-

Contacts and Locations

Cleveland

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center, Cleveland, Ohio, United States, 44106

Cleveland

Cleveland Clinic, Case Comprehensive Cancer Center, Cleveland, Ohio, United States, 44195

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Case Comprehensive Cancer Center,

Erin Murphy, MD, PRINCIPAL_INVESTIGATOR, Case Comprehensive Cancer Center

Study Record Dates

2024-12-01