The purpose of this study is to study if giving radiation to a brain tumor (a procedure called radiosurgery) before neurosurgery (surgery to remove the tumor) will help to keep brain tissue healthy, while possibly eliminating the need to return for radiation once a patient has healed from neurosurgery. This study will also seek the best radiation dose on a brain tumor based on how well the radiation therapy works and asses the side-effects.
Radiosurgery is a non-surgical radiation therapy that can deliver targeted radiation to small brain tumors. Radiosurgery is considered to be part of standard of care. Typically for standard of care, radiosurgery is given after a patient has healed from neurosurgery, in an attempt to destroy any cancer cells that may be left after surgery. Patients who agree to participate in this research study will receive radiosurgery before their neurosurgery. The timing of radiosurgery (pre-operatively) and the dosing to determine the safest dose is considered experimental. By giving radiation the typical way, after surgery, a larger area of the brain must be covered, which means healthy brain tissue also receives radiation, whereas radiation before surgery will specifically target the tumor.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Dose escalation of neoadjuvant stereotactic radiosurgery
Surgical resection of newly diagnosed brain metastases
Cedars-Sinai Medical Center
Los Angeles, California, United States
Maximum tolerated dose (MTD)
To determine the maximum tolerated dose of radiosurgery given prior to neurosurgery in subjects with brain metastases of up to 4 cm.
Time frame: 1 month after neurosurgery
Adverse events
To describe the adverse events associated with radiosurgery when administered prior to neurosurgical resection of brain metastases.
Time frame: 1 month after neurosurgery
Describe preliminary rates of image-complete resection
Time frame: 3 years
Describe preliminary rates of local tumor control
Time frame: 3 years
Describe preliminary rates of intracranial control
Time frame: 3 years
Describe preliminary rates of progression-free survival
Time frame: 3 years
Describe preliminary rates of leptomeningeal spread
Time frame: 3 years
Describe preliminary rates of rate of salvage treatment
Salvage treatment is any additional local treatment (surgery or radiation) in the setting of recurrent or progressive disease after the current treatment.
Time frame: 3 years
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