Surgery or LITT followed by a second focused radiosurgery versus close monitoring for recurrent brain metastases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional study enrolls adults with recurrent brain metastases that were previously treated with stereotactic radiosurgery and now show radiographic progression. Patients who undergo surgery or laser interstitial thermal therapy (LITT) and have active tumor on pathology may receive a second course of stereotactic radiosurgery (SRS2) after the procedure or undergo close surveillance; a parallel cohort summarizes outcomes for patients receiving SRS2 alone when surgery/LITT is not an option. The primary endpoint is time to local recurrence; secondary endpoints include distant brain metastasis-free survival, intracranial and overall progression-free survival, neurologic death, overall survival, patient-reported neurocognitive and quality-of-life measures, and rates of radionecrosis and other adverse events. The protocol requires MRI imaging, multidisciplinary evaluation, and treatment and follow-up at the enrolling center.

Why it matters

Who can join: the full rules

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.

Where it's running

• The University of Texas M. D. Anderson Cancer Center
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Subha Perni, MD — M.D. Anderson Cancer Center
• Study coordinator: Subha Perni, MD
• Email: sperni@mdanderson.org
• Phone: 713-563-2543

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.