Brain MetastasesPhase 2NCT07053033
Laser Interstitial Thermal Therapy (LITT) or Surgery and Adjuvant Reirradiation for Recurrent Brain Metastases (LaSAR BeaM)
A Phase 2 study testing Surgery and LITT in people with Brain Metastases, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
standard paradigm for management of patients who present with concern for recurrence of brain metastases following initial stereotactic radiosurgery (SRS). 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?
- Surgery and LITT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2026to 30 Dec 2028
- Phase
- Phase 2
- 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
- Ability to understand and the willingness to sign a written informed consent document.
- Willingness to comply with all study procedures and availability for the duration of the study.
- Age ≥18 years. Because no dosing or adverse event data are currently available on the use of SRS2, children are excluded from this study.
- Karnofsky performance status ≥ 60.
- Radiographic concern for progression of a solid tumor brain metastasis that has received prior stereotactic radiosurgery ≥ 3 months prior to study enrollment.
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension as ≥5 mm with MRI scan.
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- Have active tumor on pathology from surgery/LITT for this lesion.
- Able to safely undergo MRI imaging.
- Acceptable candidate for SRS2 per treating physician and multidisciplinary conference consensus.
- Have no radiographic evidence of leptomeningeal disease on radiology report or neuro-radiologist review.
- Patients with a prior or concurrent malignancy whose natural history or treatment does not interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
Who cannot join
- Patients with brain metastases from hematologic malignancies due to significant differences in radiosensitivity and treatment paradigms.
- Patients with psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant women are excluded from this study because radiation has the potential for teratogenic or abortifacient effects. All female patients between the onset of menses and 55 years will receive a pregnancy test prior to SRS2 unless the patient presents with an applicable exclusionary factor which may be one of the following:
- Postmenopausal (no menses in greater than or equal to 12 consecutive months).
- History of hysterectomy or bilateral salpingo-oophorectomy.
- Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).
- History of bilateral tubal ligation or another surgical sterilization procedure.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, 77030
Subha Perni, MD, 713-563-2543, sperni@mdanderson.org
Subha Perni, MD
About this study
standard paradigm for management of patients who present with concern for recurrence of brain metastases following initial stereotactic radiosurgery (SRS).
Read the detailed description
Primary Objective:
To determine whether SRS2 following surgery/LITT for patients with recurrent previously irradiated brain metastases improves time to local recurrence compared to close surveillance following surgery/LITT.
To summarize time to local recurrence for patients with recurrent previously irradiated brain metastases receiving SRS2 due to being ineligible for surgery/LITT.
Secondary Objectives:
To test if the effect of SRS2 versus surveillance after LITT or surgery in patients with recurrent previously irradiated brain metastases is associated with the type of surgical intervention.
To determine whether SRS2 versus close surveillance following surgery/LITT for recurrent previously irradiated brain metastases improves distant brain metastasis-free survival, intracranial progression-free survival, overall progression-free survival, neurologic death rates, and/or overall survival.
To summarize distant brain metastasis-free survival, intracranial progression-free survival, overall progression-free survival, neurologic death rates, and/or overall survival for patients receiving SRS2 alone for recurrent, previously irradiated brain metastases.
To summarize patient-reported outcomes including neurocognitive symptoms, functional independence, and quality of life for patients who receive SRS2 for recurrent, previously irradiated brain metastases.
To summarize radionecrosis and adverse event rates for patients who receive SRS2 following surgery/LITT for recurrent previously irradiated brain metastases.
- Conditions
- Brain Metastases
- Being tested
- Surgery, LITT
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryProcedure or surgery
Participants will initially undergo craniotomy and surgical resection of lesions or LITT
LITTProcedure or surgery
Participants will undergo 4-core stereotactic biopsy and LITT by experienced neurosurgeons with specific expertise.
| Study group | Role | What they receive |
|---|---|---|
| Eligible for surgery or LITT-Surveillance | Experimental | Patients will be randomized in a 1:1 manner to close surveillance versus SRS2. Receives: Procedure: Surgery; Procedure: LITT |
| Eligible for surgery or LITT-SRS2 | Experimental | Patients will be randomized in a 1:1 manner to close surveillance versus SRS2. Receives: Procedure: Surgery; Procedure: LITT |
| Ineligible for surgery or LITT-SRS2 | Experimental | Patients will be randomized in a 1:1 manner to close surveillance versus SRS2. Receives: Procedure: Surgery; Procedure: LITT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Adverse Events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured: Through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start1 Jan 2026
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2028 (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.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 155 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Subha Perni, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07053033
- Sponsor's protocol ID
- 2025-0377
- Other IDs
- NCI-2025-04737
- Status last verified
- Sep 2026
- First submitted
- 30 Jun 2025
- Last updated
- 18 Sep 2026
- 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 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laser Interstitial Thermal Therapy (LITT) or Surgery and Adjuvant Reirradiation for Recurrent Brain Metastases (LaSAR BeaM)
- ClinicalTrials.gov ID
- NCT07053033
- Acronym / sponsor ID
- 2025-0377
- Conditions
- Brain Metastases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 155 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 8 Jul 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.
standard paradigm for management of patients who present with concern for recurrence of brain metastases following initial stereotactic radiosurgery (SRS).
Detailed description
Primary Objective:
To determine whether SRS2 following surgery/LITT for patients with recurrent previously irradiated brain metastases improves time to local recurrence compared to close surveillance following surgery/LITT.
To summarize time to local recurrence for patients with recurrent previously irradiated brain metastases receiving SRS2 due to being ineligible for surgery/LITT.
Secondary Objectives:
To test if the effect of SRS2 versus surveillance after LITT or surgery in patients with recurrent previously irradiated brain metastases is associated with the type of surgical intervention.
To determine whether SRS2 versus close surveillance following surgery/LITT for recurrent previously irradiated brain metastases improves distant brain metastasis-free survival, intracranial progression-free survival, overall progression-free survival, neurologic death rates, and/or overall survival.
To summarize distant brain metastasis-free survival, intracranial progression-free survival, overall progression-free survival, neurologic death rates, and/or overall survival for patients receiving SRS2 alone for recurrent, previously irradiated brain metastases.
To summarize patient-reported outcomes including neurocognitive symptoms, functional independence, and quality of life for patients who receive SRS2 for recurrent, previously irradiated brain metastases.
To summarize radionecrosis and adverse event rates for patients who receive SRS2 following surgery/LITT for recurrent previously irradiated brain metastases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Eligible for surgery or LITT-Surveillance | Experimental | Procedure: Surgery, Procedure: LITTPatients will be randomized in a 1:1 manner to close surveillance versus SRS2. |
| Eligible for surgery or LITT-SRS2 | Experimental | Procedure: Surgery, Procedure: LITTPatients will be randomized in a 1:1 manner to close surveillance versus SRS2. |
| Ineligible for surgery or LITT-SRS2 | Experimental | Procedure: Surgery, Procedure: LITTPatients will be randomized in a 1:1 manner to close surveillance versus SRS2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Ability to understand and the willingness to sign a written informed consent document.
- Willingness to comply with all study procedures and availability for the duration of the study.
- Age ≥18 years. Because no dosing or adverse event data are currently available on the use of SRS2, children are excluded from this study.
- Karnofsky performance status ≥ 60.
- Radiographic concern for progression of a solid tumor brain metastasis that has received prior stereotactic radiosurgery ≥ 3 months prior to study enrollment.
Key exclusion criteria (7 listed)
- Patients with brain metastases from hematologic malignancies due to significant differences in radiosensitivity and treatment paradigms.
- Patients with psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant women are excluded from this study because radiation has the potential for teratogenic or abortifacient effects. All female patients between the onset of menses and 55 years will receive a pregnancy test prior to SRS2 unless the patient presents with an applicable exclusionary factor which may be one of the following:
- Postmenopausal (no menses in greater than or equal to 12 consecutive months).
- History of hysterectomy or bilateral salpingo-oophorectomy.
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 |
|---|---|---|
| SurgeryParticipants will initially undergo craniotomy and surgical resection of lesions or LITT | Procedure or surgery | Eligible for surgery or LITT-SRS2, Eligible for surgery or LITT-Surveillance, Ineligible for surgery or LITT-SRS2 |
| LITTParticipants will undergo 4-core stereotactic biopsy and LITT by experienced neurosurgeons with specific expertise. | Procedure or surgery | Eligible for surgery or LITT-SRS2, Eligible for surgery or LITT-Surveillance, Ineligible for surgery or LITT-SRS2 |
Primary outcome
Safety and Adverse Events (AEs)
Time frame: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
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 18 Sep 2026.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Subha Perni, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Surgery and LITT in people with Brain Metastases, run by M.D. Anderson Cancer Center at 1 site in United States.
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 11 inclusion and 7 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 18 Sep 2026. 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 United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Subha Perni, MD (713-563-2543, sperni@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Adverse Events (AEs) (time frame: Through study completion; an average of 1 year). 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 18 Sep 2026.