Details
Description
Inclusion Criteria
Exclusion Criteria
Details
Title Neoadjuvant Radiosurgery for resectable brain metastases: Phase I/II Study
IRB CASE7312
CC 13-143
Hospital Main Campus, Main Campus
Phase Phase 1, Phase 2
Disease Brain, Brain
Description
Primary- 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)
- To determine the local control of brain metastases treated with neoadjuvant radiosurgery followed by surgical resection. (Phase II)
- To determine the rate of distant brain failure when brain metastases are managed with neoadjuvant radiosurgery followed by surgical resection
- To estimate the rate of salvage surgery, WBRT, or SRS for patients treated with neoadjuvant radiosurgery followed by surgical resection
- To estimate neurocognitive outcomes for patients treated with neoadjuvant radiosurgery followed by surgical resection
- To determine the rate of radiation necrosis / steroid dependency
- To estimate quality of life for patients treated with neoadjuvant radiosurgery followed by surgical resection
- To determine the radiobiologic impact of neoadjuvant radiosurgery for resected brain metastases.
Inclusion Criteria
- Patient must be at least 18 years of age and have a prior histologic diagnosis of cancer other than small cell lung cancer, lymphoma, and germ cell histologies
- 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 Gy or less to optic nerve/chiasm
- Tumor located in the brainstem
- Imaging or cytologic evidence of leptomeningeal disease