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Efficacy of the Association of Fractionated SRS and Subsequent Surgery in Patients With Brain Metastases
Sponsor: Regina Elena Cancer Institute
Summary
In this study, the possibility of performing a preoperative neoadjuvant radiotherapy dose of 27 Gy fractionated in 3 sessions is explored, to maximize the biological effect of the treatment, in patients affected by solid tumors, in particular lung, breast and melanoma, in which brain metastases have arisen, the incidence of which is constantly increasing in relation to the improvements in oncological therapies and the consequent increase in patient survival. It was demonstrated that postoperative stereotactic radiosurgery with this fractionation was effective in improving local disease control at 1 year compared to single-dose stereotactic radiosurgery (91% vs 77%) and in reducing the risk of radionecrosis for metastatic brain lesions of size.
Official title: Prospective Clinical Study on the Efficacy of the Association of Fractionated SRS and Subsequent Surgery in Patients With Brain Metastases
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
98
Start Date
2024-09-26
Completion Date
2029-09-26
Last Updated
2025-05-28
Healthy Volunteers
No
Conditions
Interventions
Treatment based on stereotactic radiosurgery
Treatment based on stereotactic radiosurgery fractionated within 48-72, followed by surgery for symptomatic brain lesions, amenable to surgical treatment, associated or not with a maximum of 3 additional smaller metastatic brain lesions. The dose will be 27 Gy in three fractions (9 Gy per fraction) on alternate days. If other lesions are present, up to a maximum of 3 lesions and a total volume of 35 cc, these will be treated with radical stereotactic radiosurgery according to guidelines.
Locations (1)
"Regina Elena" National Cancer Institute
Rome, Italy