Surgery or LITT followed by a second focused radiosurgery versus close monitoring for recurrent brain metastases

Laser Interstitial Thermal Therapy (LITT) or Surgery and Adjuvant Reirradiation for Recurrent Brain Metastases (LaSAR BeaM)

This trial tests whether giving a second course of stereotactic radiosurgery after surgery or LITT helps people with recurrent brain metastases keep the tumor from coming back compared with close monitoring.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 155 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: M.D. Anderson Cancer Center (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT07053033 on ClinicalTrials.gov

What this trial studies

This Phase 2 interventional study enrolls adults with recurrent brain metastases that were previously treated with stereotactic radiosurgery and now show radiographic progression. Patients who undergo surgery or laser interstitial thermal therapy (LITT) and have active tumor on pathology may receive a second course of stereotactic radiosurgery (SRS2) after the procedure or undergo close surveillance; a parallel cohort summarizes outcomes for patients receiving SRS2 alone when surgery/LITT is not an option. The primary endpoint is time to local recurrence; secondary endpoints include distant brain metastasis-free survival, intracranial and overall progression-free survival, neurologic death, overall survival, patient-reported neurocognitive and quality-of-life measures, and rates of radionecrosis and other adverse events. The protocol requires MRI imaging, multidisciplinary evaluation, and treatment and follow-up at the enrolling center.

Who should consider this trial

Good fit: Adults (≥18) with measurable recurrent brain metastasis previously treated with SRS, a Karnofsky performance status ≥60, active tumor on surgery/LITT pathology, ability to undergo MRI, and who are considered acceptable candidates for SRS2 are ideal for this study.

Not a fit: Patients with leptomeningeal disease, poor functional status (KPS <60), pediatric patients, lesions too small to measure, or those without active tumor on pathology are unlikely to receive benefit from the interventions tested here.

Why it matters

Potential benefit: If successful, the approach could lengthen the time before brain tumors recur and improve intracranial disease control and quality of life after treatment.

How similar studies have performed: Repeat SRS and LITT have shown encouraging results in retrospective series and small prospective cohorts, but high-quality randomized evidence is limited.

Eligibility criteria

Inclusion Criteria:

* 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.
* 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.

Exclusion Criteria:

* 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.

Where this trial is running

Houston, Texas

• The University of Texas M. D. Anderson Cancer Center — Houston, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Subha Perni, MD — M.D. Anderson Cancer Center
• Study coordinator: Subha Perni, MD

Conditions Brain Metastases