This study will investigate the safety, tolerability, and effectiveness of changing the order of receiving radiation therapy for treating brain cancer. The investigators hope that changing the sequence of radiation therapy will lower the risk of cancer spreading throughout your spinal fluid, which covers your brain and spinal cord.
This study will attempt to determine the maximum tolerated dose of pre-operative stereotactic radiosurgery (SRS) in the treatment of brain metastases. Patients will be placed in one of two dose groups based on index tumor size, and dose will be adjusted according to presence or absence of dose limiting toxicity (DLT). Group A: Index Tumor \> 2 cm and up to 4 cm in maximum diameter Group B: Index Tumor \> 4 cm and up to 6 cm in maximum diameter Dose escalation or de-escalation will be conducted via a modified 3+3 method at the following levels. Group A will start at dose level II. Group B will start at dose level I. Dose Level I: 12 Gy Dose Level II: 15 Gy
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
20
Group A will start at dose level II: 15 Gy Group B will start at dose level I: 12 Gy
Group B will start at Dose Level I: 12 Gy
Hazelrig-Salter Radiation Oncology Center/University of Alabama at Birmingham
Birmingham, Alabama, United States
maximum tolerated dose (MTD) of preoperative stereotactic radiosurgery (SRS) for brain metastasis
The maximum tolerated dose (MTD) is defined as the highest dose of stereotactic radiosurgery delivered pre-operative at which no more than 2 out of 6 patients experience a dose limiting toxicity (DLT).
Time frame: one year
Acute Toxicity with preoperative stereotactic radiosurgery (SRS)
Any possible, probable, or definite treatment-related AE or SAE (assessed by CTCAE 4.0) occurring within six months or less from the date of stereotactic radiosurgery was received.
Time frame: 6 months
Late Toxicity with preoperative stereotactic radiosurgery (SRS)
Any possible, probable, or definite treatment-related AE or SAE (assessed by CTCAE 4.0) occurring more than six months from the date of stereotactic radiosurgery was received.
Time frame: 1 year
Rates of Local Control
This will be assessed by MRI Imaging obtained post-operatively at follow-up visits.
Time frame: 2 years
Rates of Leptomeningeal Dissemination
Leptomeningeal Dissemination (LMD) defined as diffuse carcinomatosis and/or distant focal pachymeningeal (dural) tumor and assessed by MRI Imaging for the study period.
Time frame: 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.