Prospective Clinical Study on the Efficacy of the Association of Fractionated SRS and Subsequent Surgery in Patients With Brain Metastases

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
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 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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
Regina Elena National Cancer Institute
RECRUITING
Rome
Contact Information
Primary
Stefano Telera, Doctor
stefano.telera@ifo.it
0652662737
Time Frame
Start Date: 2024-09-26
Estimated Completion Date: 2029-09-26
Participants
Target number of participants: 98
Treatments
Experimental: Patients with brain metastases
Patients with single metastatic brain lesions with a diameter ≥ 3 cm symptomatic or asymptomatic or with symptomatic brain lesions ≥ 2 cm \< 3 cm that are surgically resectable, without or in the presence of a maximum of 3 small synchronous lesions amenable to radiosurgery treatment, will undergo radiation treatment of 27 Gy in three fractions (9 Gy per fraction) on alternate days; If other lesions are present, up to a maximum of 3 lesions and a total volume of 35 cc, these will be treated with radical stereotactic radiosurgery according to guidelines
Related Therapeutic Areas
Sponsors
Leads: Regina Elena Cancer Institute

This content was sourced from clinicaltrials.gov