Laser Interstitial Thermal Therapy (LITT) or Surgery and Adjuvant Reirradiation for Recurrent Brain Metastases (LaSAR BeaM)
Launched by M.D. ANDERSON CANCER CENTER · Jun 30, 2025
Trial Information
Current as of July 22, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying new ways to treat brain metastases, which are cancer spots that have spread to the brain, when they come back after initial treatment with a focused type of radiation called stereotactic radiosurgery (SRS). The trial is comparing two treatment options: a less invasive procedure using a laser to heat and destroy tumor tissue (called Laser Interstitial Thermal Therapy or LITT) versus traditional surgery, both followed by a second round of targeted radiation. The goal is to find out which approach works better and is safer for patients whose brain tumors have returned.
Adults aged 18 and older who have previously been treated with SRS and now have signs that their brain tumor may be growing again might be eligible. To join, patients need to be well enough to participate and have a tumor that can be measured on an MRI scan. Patients must not have certain types of cancer, like blood cancers, or other health or social issues that would make it hard to follow the study plan. Women who could become pregnant will have a pregnancy test before treatment to ensure safety. Participants can expect to undergo either the laser treatment or surgery, followed by another course of radiation, along with regular imaging tests and check-ups to monitor their progress. This study is not yet open for enrollment but aims to help improve care for people facing recurrent brain metastases.
Gender
ALL
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.
About M.D. Anderson Cancer Center
The University of Texas MD Anderson Cancer Center is a leading institution dedicated to cancer care, research, education, and prevention. As one of the world’s most respected cancer centers, MD Anderson focuses on innovative treatment approaches and groundbreaking clinical trials aimed at improving patient outcomes. With a multidisciplinary team of experts and state-of-the-art facilities, the center is committed to advancing cancer research and providing comprehensive, personalized care to patients. MD Anderson's clinical trials play a pivotal role in translating scientific discoveries into effective therapies, positioning the center at the forefront of cancer treatment and research.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Houston, Texas, United States
Patients applied
Trial Officials
Subha Perni, MD
Principal Investigator
M.D. Anderson Cancer Center
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported