Actively Recruiting
Efficacy of the Association of Fractionated SRS and Subsequent Surgery in Patients With Brain Metastases
Led by Regina Elena Cancer Institute · Updated on 2025-05-28
98
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy of the Association of Fractionated SRS and Subsequent Surgery in Patients With Brain Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with a single brain metastasis at least 3 cm in diameter, symptomatic or asymptomatic, or symptomatic lesions between 2 and 3 cm that can be surgically removed, with up to 3 additional small lesions treatable by radiosurgery
- No urgent need for surgery due to neurological symptoms or worsening brain pressure
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
- Karnofsky Performance Status of 60 or higher
- Life expectancy greater than 3 months
- Suitable for surgery with ASA score of 3 or less
- No contraindications for brain MRI with and without contrast
- Able to understand and willing to sign informed consent
You will not qualify if you...
- Contraindications to radiotherapy treatment
- Pregnancy
- Unable to follow study procedures or complete questionnaires
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
"Regina Elena" National Cancer Institute
Rome, Italy, 00144
Actively Recruiting
Research Team
S
Stefano Telera, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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