Efficacy of the Association of Fractionated SRS and Subsequent Surgery in Patients With Brain Metastases
Launched by REGINA ELENA CANCER INSTITUTE · May 19, 2025
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at a new way to treat patients with brain metastases, which are cancerous tumors that have spread to the brain from other parts of the body, like the lungs or breasts. The study is testing a combination of targeted radiation therapy given before surgery and the usual radiation therapy after surgery. The goal is to see if this approach can help control the cancer better and reduce side effects compared to traditional methods. Early results suggest that this new method may improve treatment outcomes for patients.
To be eligible for this trial, participants need to be at least 18 years old and have a single brain tumor that is at least 2 cm in size and can be surgically removed. They should not have urgent neurological issues and must be able to understand and sign a consent form. During the study, participants will receive the new treatment and will be monitored closely for their health. This trial is currently recruiting and welcomes all genders, aiming to improve the care and outcomes for patients facing brain metastases.
Gender
ALL
Eligibility criteria
- 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;
About Regina Elena Cancer Institute
The Regina Elena Cancer Institute is a leading research and treatment center dedicated to advancing oncology through innovative clinical trials and comprehensive patient care. Located in Rome, Italy, the institute is committed to enhancing cancer treatment methodologies and improving patient outcomes by fostering a collaborative environment among clinicians, researchers, and patients. With a focus on cutting-edge therapies and personalized medicine, the Regina Elena Cancer Institute plays a pivotal role in the global fight against cancer, contributing to significant breakthroughs in cancer research and treatment protocols.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Rome, , Italy
Patients applied
Trial Officials
Stefano Telera, Doctor
Principal Investigator
IRCCS National Cancer Institute
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported