Clinical trial · Interventional
Laser Interstitial Thermal Therapy (LITT) or Surgery and Adjuvant Reirradiation for Recurrent Brain Metastases (LaSAR BeaM)
NCT07053033CI-TRIAL-00104989recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 19, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260919-000001
Summary
Brief summary (as posted)
standard paradigm for management of patients who present with concern for recurrence of brain metastases following initial stereotactic radiosurgery (SRS).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Metastases | Brain Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LITT | Procedure | — | UNRESOLVED |
| Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Eligible for surgery or LITT-Surveillance
- description
- Patients will be randomized in a 1:1 manner to close surveillance versus SRS2.
- interventionNames
- Procedure: Surgery
- Procedure: LITT
- type
- EXPERIMENTAL
- label
- Eligible for surgery or LITT-SRS2
- description
- Patients will be randomized in a 1:1 manner to close surveillance versus SRS2.
- interventionNames
- Procedure: Surgery
- Procedure: LITT
- type
- EXPERIMENTAL
- label
- Ineligible for surgery or LITT-SRS2
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.