RecruitingNot ApplicableNCT06992973

Efficacy of the Association of Fractionated SRS and Subsequent Surgery in Patients With Brain Metastases

Prospective Clinical Study on the Efficacy of the Association of Fractionated SRS and Subsequent Surgery in Patients With Brain Metastases

Sponsor

Regina Elena Cancer Institute

Enrollment

98 participants

Start Date

Sep 26, 2024

Study Type

INTERVENTIONAL

Conditions

Brain Metastases

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether performing stereotactic radiosurgery (a very precise type of radiation) on a brain metastasis before surgical removal — rather than after — reduces the risk of cancer cells spreading in the brain during or after the operation. **You may be eligible if...** - You are 18 or older with a single brain metastasis of 3 cm or larger, or a symptomatic metastasis of 2–3 cm - You may have up to 3 additional small metastases treatable with radiosurgery - You are healthy enough for brain surgery (ASA score 3 or below) - You have a life expectancy of more than 3 months **You may NOT be eligible if...** - You need emergency surgery for severe brain swelling or neurological symptoms - You have a contraindication to radiation therapy or brain MRI - You are pregnant - You are unable to follow the study procedures or complete required questionnaires Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONTreatment 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.