Pilot test of an active surveillance approach for brain metastases during CNS-penetrant systemic therapy

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 observational pilot will monitor patients with brain metastases who are starting a new systemic therapy that can affect the CNS. The study focuses on safety of actively surveilling local therapy decisions rather than immediate intervention. Participants must have measurable or non-measurable brain metastases, no symptoms from active brain metastases, and no prior local brain treatment for the current lesions. Eligibility requires planning to begin a new systemic therapy with potential CNS activity, as judged by treating physicians. No interventions are specified within the study itself; the approach centers on surveillance and local therapy decision-making.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients must have histologically or cytologically confirmed metastatic non-hematologic malignancy.
* Patients must have at least one new or progressive brain metastasis that has not received prior local therapy (surgery or radiation therapy).
* Patients must have no active brain metastasis \>3cm in size.
* Leptomeningeal disease is permitted
* Patients with only non-measurable disease as defined by the RANO-BM criteria are permitted so long as the clinical determination of new or progressive disease has been made by the treating team.
* Patients must have no symptoms attributable to active brain metastases.
* At the time of enrollment, patients must be eligible for AND planning to begin a new line of systemic therapy with potential for CNS-efficacy. Determination of potential for CNS-efficacy will be determined based on the clinical judgement of the treating physicians. Patients must have had no prior exposure to the specific systemic therapy in question at the time of enrollment, though exposure to other medications from a similar class are acceptable at the discretion of the treating team.
* Patient must be planning to defer radiation therapy to trial medical therapy regardless of enrollment on trial.
* Must be age ≥ 18 years.
* Patients must be willing to complete MoCA and FACT-BR assessments (refer to section 4.4.1).
* Performance status: KPS performance status ≥50%.
* Life expectancy of ≥3 months.
* Ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria:

* Patients who have only progressive growth of brain lesions that have previously been treated with surgery or radiation therapy.
* Patients with active symptomatic brain metastases.
* Patients requiring corticosteroids, anticonvulsants, or other palliative medications related to brain metastases.
* Patients with conditions that exclude them from undergoing magnetic resonance imaging.

Where it's running

• Chao Family Comprehensive Cancer Center, University of California, Irvine
  Orange, California, United States Recruiting

Study contacts

• Principal investigator: Aaron Simon, MD — Chao Family Comprehensive Cancer Center
• Study coordinator: Chao Family Comprehensive Cancer Center University of California, Irvine
• Email: ucstudy@uci.edu
• Phone: 1-877-827-8839

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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.