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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Postmenopausal (no menses in greater than or equal to 12 consecutive months).

History of hysterectomy or bilateral salpingo-oophorectomy.

Trial design

Design model

Single group

Treatments tested in this trial

  • Surgery

    Procedure/Surgery

    Participants will initially undergo craniotomy and surgical resection of lesions or LITT

  • LITT

    Procedure/Surgery

    Participants will undergo 4-core stereotactic biopsy and LITT by experienced neurosurgeons with specific expertise.

Treatment groups

155 Participants
are divided into 3 treatment groups
Group A: Eligible for surgery or LITT-SurveillanceExperimental treatment 2 interventions
Group B: Eligible for surgery or LITT-SRS2Experimental treatment 2 interventions
Group C: Ineligible for surgery or LITT-SRS2Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Safety and Adverse Events (AEs)

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Time frame
Through study completion; an average of 1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

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