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

NCT06992973 | Recruiting

• 1 other identifier: RS155/IRE/24
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Brain Metastases

Outcome Measures

Primary Outcomes (1)

• Local disease control

  To evaluate the efficacy of treatment based on Fractionated Stereotactic Radiosurgery followed (within 48-72 h) by Surgery for symptomatic brain lesions (susceptible to surgical treatment) associated or not with a maximum of 3 additional smaller brain metastatic lesions (susceptible to radiosurgical treatment). Local control of the disease after 24 months from treatment by carrying out all the evaluations and analyses that are part of the clinical management of this type of patient and required by the planned radio-surgical treatment.

  24 months

Study Arms (1)

Patients with brain metastases

EXPERIMENTAL

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

Radiation: Treatment based on stereotactic radiosurgery

Interventions

Treatment based on stereotactic radiosurgery RADIATION

Treatment based on stereotactic radiosurgery fractionated within 48-72, followed by surgery for symptomatic brain lesions, amenable to surgical treatment, associated or not with a maximum of 3 additional smaller metastatic brain lesions. The dose will be 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.

Patients with brain metastases

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• contraindications to radiotherapy treatment;
• pregnancy;
• inability to follow the procedures, to fill out the questionnaires;

Sponsors & Collaborators

• Regina Elena Cancer Institute: lead

Study Sites (1)

"Regina Elena" National Cancer Institute

Rome, 00144, Italy

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Stefano Telera, Doctor

  IRCCS National Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefano Telera, Doctor

CONTACT

0652662737; stefano.telera@ifo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: May 28, 2025
• Study Start: September 26, 2024
• Primary Completion (Estimated): September 26, 2029
• Study Completion (Estimated): September 26, 2029
• Last Updated: May 28, 2025

Record last verified: 2025-05

Locations

IT (1)