RECRUITINGPhase 1 / Phase 2INTERVENTIONAL
Neoadjuvant Radiosurgery for Resectable Brain Metastases: Phase I/II Study
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
RADIATION
radiosurgery
Undergo radiosurgery
PROCEDURE
therapeutic conventional surgery
Undergo surgical resection
PROCEDURE
quality-of-life assessment
Ancillary studies
Locations (2)
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Cleveland Clinic, Case Comprehensive Cancer Center
Cleveland, Ohio, United States