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

M.D. Anderson Cancer Center2 个研究点分布在 1 个国家目标入组 155 人开始时间: 2026年1月1日最近更新: 2026年3月9日

干预措施

试验速览

阶段: 2 期
状态: 招募中
发起方: M.D. Anderson Cancer Center
入组人数: 155
试验地点: 2
主要终点: Safety and Adverse Events (AEs)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

standard paradigm for management of patients who present with concern for recurrence of brain metastases following initial stereotactic radiosurgery (SRS).

详细描述

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.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•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 ≥
•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.

排除标准

•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.