This study will be a non-randomized phase II trial for patients with one to six brain metastases, at least one of which is appropriate for surgical resection. Upon registration, patients will be assigned to receive neo-adjuvant stereotactic radiosurgery (NASRS).
Recently, a novel treatment strategy for large brain metastases was described whereby lesions appropriate for resection were treated with a single fraction of SRS pre-operatively. In a retrospective analysis, of 51 lesions with a median tumor size of 3 cm, 1-year LC was 86%. This neoadjuvant approach resulted in lower rates of leptomeningeal failure (3 vs. 17%) and symptomatic radiation toxicity (1.5 vs. 14.6 %) compared to a comparative cohort of lesions treated with post-operative cavity boost SRS (POCBS). Based on promising results, we believe that a prospective trial to establish the value of neoadjuvant SRS (NaSRS) for the treatment of BM appropriate for resection is warranted. This study will be a non-randomized phase II trial for patients with one to six brain metastases, at least one of which is appropriate for surgical resection. Upon registration, patients will be assigned to receive neo-adjuvant stereotactic radiosurgery (NASRS).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Stereotactic Radiosurgery before surgical resection of brain mets.
University Health Network
Toronto, Ontario, Canada
Charité Universitätsmedizin Berlin, Campus Virchow Klinikum
Berlin, Germany
Radiation toxicity
The rate at 1 year of symptomatic (≥grade 2) radiation toxicity
Time frame: 1 year
local control
1-year local control (PR+CR) of the index lesion resulting from NaSRS
Time frame: 1 year
leptomeningeal disease
1-year rates of leptomeningeal disease
Time frame: 1 year
Survival
Median survival
Time frame: 5 years
progression-free survival
Time frame: 2 years
overall survival
Time frame: 2 years
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