About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
radiosurgery
RadiationUndergo radiosurgery
therapeutic conventional surgery
Procedure/SurgeryUndergo surgical resection
quality-of-life assessment
Procedure/SurgeryAncillary studies
Treatment groups
Trial outcomes
Primary outcomes
Maximum tolerated dose (MTD)
MTD of radiosurgery determined by dose-limiting toxicities graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0 (Phase I)
Proportion of participants without local failure (Phase II)
Local control of brain metastases, as measured by proportion of participants without local failure (Local failure is tumor progression of the metastasis treated on the study) (Phase II) The Kaplan-Meier method will be used.
Secondary outcomes
Proportion of participants with distant brain failure
Rate of distant brain failure, defined as progression of brain metastases outside of the brain metastasis treated on study. The Kaplan-Meier method will be used.
Rate of radiation necrosis/steroid dependency
Rate of radiation necrosis/steroid dependency
Rate of salvage treatment
Number of patients that have any salvage treatment, including surgery, stereotactic radiosurgery (SRS), or whole brain radiation therapy (WBRT)
Sponsors and contacts
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