Brain MetastasesNCT06992973
Efficacy of the Association of Fractionated SRS and Subsequent Surgery in Patients With Brain Metastases
A study testing Treatment based on stereotactic radiosurgery in people with Brain Metastases, run by Regina Elena Cancer Institute at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Metastases
- What is being tested?
- Treatment based on stereotactic radiosurgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteItaly
- Study dates
- 26 Sep 2024to 26 Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- contraindications to radiotherapy treatment;
- pregnancy;
- inability to follow the procedures, to fill out the questionnaires;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
"Regina Elena" National Cancer Institute
Rome, 00144
Stefano Telera, Doctor, +39 06 52662911, stefano.telera@ifo.it
About this study
Official title: Prospective Clinical Study on the Efficacy of the Association of Fractionated SRS and Subsequent Surgery in Patients With Brain Metastases
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.
Read the detailed description
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.
- Conditions
- Brain Metastases
- Being tested
- Treatment based on stereotactic radiosurgery
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment based on stereotactic radiosurgeryRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Radiation: Treatment based on stereotactic radiosurgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study start26 Sep 2024
- Primary completion26 Sep 2029 (estimated)
- Study completion26 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain MetastasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regina Elena Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefano Telera, Doctor, Principal investigator, IRCCS National Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06992973
- Sponsor's protocol ID
- RS155/IRE/24
- Status last verified
- May 2025
- First submitted
- 17 Mar 2025
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Study on the Efficacy of the Association of Fractionated SRS and Subsequent Surgery in Patients With Brain Metastases
- ClinicalTrials.gov ID
- NCT06992973
- Acronym / sponsor ID
- RS155/IRE/24
- Conditions
- Brain Metastases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Regina Elena Cancer InstituteUniversity, hospital or other
- Study start
- 26 Sep 2024 (actual)
- Primary completion
- 26 Sep 2029 (estimated)
- Study completion
- 26 Sep 2029 (estimated)
- First posted
- 28 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with brain metastases | Experimental | Radiation: Treatment based on stereotactic radiosurgeryPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (3 listed)
- contraindications to radiotherapy treatment;
- pregnancy;
- inability to follow the procedures, to fill out the questionnaires;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment based on stereotactic radiosurgeryTreatment 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. | Radiation | Patients with brain metastases |
Primary outcome
Local disease control
Time frame: 24 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stefano Telera, Doctor principal investigator
IRCCS National Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment based on stereotactic radiosurgery in people with Brain Metastases, run by Regina Elena Cancer Institute at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stefano Telera, Doctor (0652662737 ext. +39, stefano.telera@ifo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local disease control (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025; AzTrials last refreshed its copy on 8 Nov 2026.