Neoadjuvant Radiosurgery for Resectable Brain Metastases: Phase I/II Study
Case Comprehensive Cancer Center
Summary
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.
Description
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 stereot…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- Radiationradiosurgery
Undergo radiosurgery
- Proceduretherapeutic conventional surgery
Undergo surgical resection
- Procedurequality-of-life assessment
Ancillary studies
Locations (2)
- University Hospitals Cleveland Medical Center, Case Comprehensive Cancer CenterCleveland, Ohio
- Cleveland Clinic, Case Comprehensive Cancer CenterCleveland, Ohio