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

Study Purpose

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.#46;77%) and in reducing the risk of radionecrosis for metastatic brain lesions of size.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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;

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06992973
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Regina Elena Cancer Institute
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Stefano Telera, Doctor
Principal Investigator Affiliation IRCCS National Cancer Institute
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Italy
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Brain Metastases
Additional Details

The treatment of potentially resectable brain metastases in association with preoperative fractionated stereotactic radiotherapy (FSRT) involves the administration of radiation therapy to an intact lesion, with the advantage of presenting fewer uncertainties in terms of target definition and does not require the addition of additional irradiation margins. Furthermore, the reduction of the dose to healthy brain tissue may lead to a lower risk of inducing subsequent radionecrosis. In fact, the volume of healthy brain tissue irradiated is a recognized predictive factor for the induction of radionecrosis. The overall reduction of treatment times (FSRT + Surgery) with higher compliance by patients and improved logistics. Furthermore, potential advantages consist in the fact that a neoadjuvant radiosurgical treatment can potentially prevent cells scattered during surgery from causing neoplastic leptomeningitis, as these would have already received ablative irradiation. That radiation treatment on a target with an intact vascular supply is potentially more effective because the irradiation bed after surgery is more hypoxic. It has been observed that over 20% of patients undergoing surgical resection of a metastasis do not undergo the planned radiosurgery due to complications, disease progression or other reasons for delay. The treatment therefore offers the possibility of delivering a higher biological dose with a greater probability of local control and a lower risk of meningeal spread and symptomatic radionecrosis.

Arms & Interventions

Arms

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

Interventions

Radiation: - Treatment based on stereotactic radiosurgery

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

"Regina Elena" National Cancer Institute, Rome, Italy

Status

Recruiting

Address

"Regina Elena" National Cancer Institute

Rome, , 00144

Site Contact

Stefano Telera, Doctor

[email protected]

+39 06 52662911

Stay Informed & Connected