Status:
RECRUITING
Efficacy of the Association of Fractionated SRS and Subsequent Surgery in Patients With Brain Metastases
Lead Sponsor:
Regina Elena Cancer Institute
Conditions:
Brain Metastases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 patien...
Detailed Description
The treatment of potentially resectable brain metastases in association with preoperative fractionated stereotactic radiotherapy (FSRT) involves the administration of radiation therapy to an intact le...
Eligibility Criteria
Inclusion
- 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
- contraindications to radiotherapy treatment;
- pregnancy;
- inability to follow the procedures, to fill out the questionnaires;
Key Trial Info
Start Date :
September 26 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 26 2029
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT06992973
Start Date
September 26 2024
End Date
September 26 2029
Last Update
May 28 2025
Active Locations (1)
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1
"Regina Elena" National Cancer Institute
Rome, Italy, 00144