Study Comparing Neoadjuvant Versus Adjuvant Stereotactic Radiotherapy of Brain Metastases

This is a phase III, prospective, multicenter, randomized, two-group, controlled, open-label interventional study designed to evaluate the efficacy in terms of local progression-free survival of neoadjuvant stereotactic radiotherapy for brain metastases compared with adjuvant stereotactic radiotherapy.

The study population is composed of adult patients with 1 to 12 newly diagnosed brain metastases who require surgical treatment for the removal of at least one lesion.

The two therapeutic strategies studied in the trial are as follows:

• SRS NEO group (experimental group): stereotactic radiotherapy administered as neoadjuvant therapy (4 days ± 1 day before surgery to remove the brain metastasis).
• POST OP SRS group (control group): stereotactic radiotherapy performed adjuvantly (4 to 6 weeks after surgery to remove the brain metastasis).

Inclusion criteria

• Patients aged 18 years and older;
• Patients with 1 to 12 brain metastases on preoperative MRI, at least one of which (contrast enhancement of at least 1 cm) is accessible for the most complete possible resection (target lesion);
• Patients with a Karnofsky performance score of ≥ 70;
• Patients able to perform neurocognitive tests without assistance;
• Patients who understand the study and agree to attend all visits;
• Patients who have signed a written informed consent form;
• Affiliation with a social security system.

Exclusion criteria

• Patient who has already been treated with surgery, radiosurgery, and/or radiotherapy for the target brain metastasis;
• Medical contraindication to MRI;
• Patient with an estimated life expectancy of ≤ 3 months;
• Patients participating in another clinical trial, or who are in the exclusion period of another clinical trial;
• Patients unable to complete a self-administered questionnaire;
• Patients from a vulnerable population.