This phase I/II trial studies the side effects and best dose radiosurgery before surgery and to see how well it works in treating patients with cancer that has spread to the brain (brain metastases) and can be removed by surgery. Radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT01891318.
Locations matching your search criteria
United States
Ohio
Cleveland
Case Comprehensive Cancer CenterStatus: Active
Contact: Erin Sennett Murphy
Phone: 216-445-4895
PRIMARY OBJECTIVES:
I. To determine the safety (risk of acute and long-term toxicities) of neoadjuvant radiosurgery at escalating doses followed by surgical resection of brain metastases. (Phase I)
II. To determine the local control of brain metastases treated with neoadjuvant radiosurgery followed by surgical resection. (Phase II)
SECONDARY OBJECTIVES:
I. To determine the rate of distant brain failure when brain metastases are managed with neoadjuvant radiosurgery followed by surgical resection.
II. To estimate the rate of salvage surgery, whole brain radiation therapy (WBRT), or stereotactic radiosurgery (SRS) for patients treated with neoadjuvant radiosurgery followed by surgical resection.
III. To determine the rate of radiation necrosis/steroid dependency.
IV. To determine the radiobiologic impact of neoadjuvant radiosurgery for resected brain metastases.
OUTLINE: This is a phase I, dose-escalation study of radiosurgery followed by a phase II study.
Patients undergo radiosurgery on day 0. Within 2 weeks, patients undergo surgical resection.
After completion of study treatment, patients are followed up at 1-2 weeks, 2 months, every 3 months until year 2, and every 6 months until year 3.
Lead OrganizationCase Comprehensive Cancer Center
Principal InvestigatorErin Sennett Murphy
