NCT07053033

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 155 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Brain Metastases

Interventions

Type	Name	Description
PROCEDURE	Surgery	Participants will initially undergo craniotomy and surgical resection of lesions or LITT
PROCEDURE	LITT	Participants will undergo 4-core stereotactic biopsy and LITT by experienced neurosurgeons with specific expertise.

Timeline

• Start date: 2026-01-01
• Primary completion: 2026-12-30
• Completion: 2028-12-30
• First posted: 2025-07-08
• Last updated: 2026-03-09

Locations

1 site across 1 country: United States