Combining fractionated stereotactic radiosurgery with surgery for brain metastases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effectiveness of administering a preoperative dose of fractionated stereotactic radiosurgery (FSRT) to patients with brain metastases from solid tumors, such as lung, breast, and melanoma. The treatment involves delivering radiation therapy to the tumor before surgical resection, aiming to enhance local disease control and reduce the risk of complications like radionecrosis. By targeting the tumor while it is still intact, the study seeks to maximize the biological impact of the treatment and improve patient outcomes. The approach is designed to minimize the volume of healthy brain tissue exposed to radiation, thereby potentially lowering the risk of adverse effects.

Why it matters

Who can join: the full rules

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;

Where it's running

• "Regina Elena" National Cancer Institute
  Rome, Italy Recruiting

Study contacts

• Principal investigator: Stefano Telera, Doctor — IRCCS National Cancer Institute
• Study coordinator: Stefano Telera, Doctor
• Email: stefano.telera@ifo.it
• Phone: 0652662737

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.