This phase II trial studies how well stereotactic radiosurgery before resection works in treating patients with solid tumors that have spread to the brain. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Performing stereotactic radiosurgery before surgery may sterilize the cancer cells surrounding the brain tumor so they may not spread during surgery.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03398694.
PRIMARY OBJECTIVE:
I. To evaluate 6 month in-brain local control utilizing pre-operative stereotactic radiosurgery followed by surgical resection for brain metastases.
SECONDARY OBJECTIVES:
I. Overall survival.
II. Distant in-brain progression.
III. Rate of leptomeningeal spread.
IV. Rate of radiation necrosis.
EXPLORATORY OBJECTIVE:
I. To explore potential immunohistochemistry markers, mitochondrial histochemistry markers and ribonucleic acid (RNA)-based biomarkers that correlate with in-brain local and distant control and overall survival in patients treated with pre-operative stereotactic radiosurgery (SRS).
OUTLINE:
Patients undergo SRS. Within 1-4 days, patients undergo surgical resection.
After completion of study treatment, patients are followed up at 4 weeks, every 3 months for 2 years, and then every 6 months thereafter.
Lead OrganizationIndiana University/Melvin and Bren Simon Cancer Center
Principal InvestigatorNamita Agrawal