Efficacy of the Association of Fractionated SRS and Subsequent Surgery in Patients With Brain Metastases

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRegina Elena Cancer Institute

About this trial

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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

contraindications to radiotherapy treatment;

pregnancy;

inability to follow the procedures, to fill out the questionnaires;

Trial design

Treatments tested in this trial

  • Treatment based on stereotactic radiosurgery

Treatment groups

98 Participants
are divided into 1 treatment group

Sponsors and collaborators