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

RecruitingNAAges 18 Years - anyAllRegina Elena Cancer Institute
NCT06992973 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * patients with single metastatic brain lesions with a diameter of ≥ 3 cm symptomatic / asymptomatic or with symptomatic brain lesions ≥ 2 cm \< 3 cm that are surgically resectable, without or in the presence of max 3 small synchronous lesions amenable to radiosurgery treatment; * no urgent surgical indication for neurological symptoms or worsening intracranial hypertension; * age ≥ 18 years; * performance status according to the Eastern Cooperative Oncology Group (ECOG) scales ≤ 2; * Karnfosky Performance Status ≥ 60; * life expectancy greater than 3 months; * patients assessed as suitable for surgery (ASA score ≤ 3) and in the absence of contraindications to undergoing brain MRI examination without and with contrast medium; * ability to understand and willingness to sign a written informed consent document. Exclusion Criteria: * contraindications to radiotherapy treatment; * pregnancy; * inability to follow the procedures, to fill out the questionnaires;
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What it tests

  • Treatment based on stereotactic radiosurgery
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Where

1 site
"Regina Elena" National Cancer Institute
Rome, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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