Efficacy of the Association of Fractionated SRS and Subsequent Surgery in Patients With Brain Metastases
Recruiting now · Not applicable
Conditions studied: Brain Metastases
In brief
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.
Key facts
- Study ID
- NCT06992973
- Run by
- Regina Elena Cancer Institute
- People needed
- 98
- Starts
- 2024-09-26
- Expected to finish
- 2029-09-26
- Last updated by the study team
- 2025-05-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- contraindications to radiotherapy treatment;
- pregnancy;
- inability to follow the procedures, to fill out the questionnaires;
Where it is running
- "Regina Elena" National Cancer Institute — Rome, Italy (enrolling)
Full record on ClinicalTrials.gov
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