Frameless stereotactic radiosurgery for intact 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 randomized trial at the University of Chicago assigns eligible adults with 1–5 measurable brain metastases to frameless stereotactic radiosurgery with or without PTV margins. Treatments are delivered using stereotactic radiosurgery techniques and patients are followed with periodic MRI to monitor intracranial control and progression-free survival. Key eligibility includes ECOG 0–2, life expectancy ≥3 months, and tumor diameters ≤3.0 cm. The trial compares intracranial control, progression-free survival, and toxicity between the margin and no-margin arms.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adult patients (≥ 18 years old) with an ECOG Performance Status 0-2 and a life expectancy of 3 months or more.
* Histologically confirmed systemic malignancy with gadolinium contrast-enhanced MRI scan demonstrating 1-5 intraparenchymal brain metastases.
* Well-circumscribed, measureable intraparenchymal brain lesion(s) with maximum tumor diameter ≤3.0 cm. If multiple lesions are present, the other(s) must not exceed 3.0 cm in maximum diameter. At least one lesion must be ≥1.0 cm in maximum diameter and ≥0.5 cm in a perpendicular diameter to be considered measurable disease.
* Negative urine or serum pregnancy test done ≤ 14 days prior to CT simulation, for women of child-bearing potential only.
* Ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria:

* Diagnosis of germ cell tumor, small cell carcinoma or hematologic malignancy.
* Metastases in the brain stem, midbrain, pons, medulla, or within 7 mm of the optic apparatus (optic nerves, chiasm and optic tracts).
* Diagnosis of leptomeningeal disease.
* Prior cranial radiotherapy within 90 days of trial enrollment or prior SRS at any time to any lesion to be treated on protocol
* Chemotherapy (including oral agents and targeted agents) or immunotherapy given within 14 days of SRS. Hormonal therapy is permitted. For Her2+ breast cancer patients, anti-Her2 therapy cannot be given within 14 days of SRS. Patients who are scheduled to receive trastuzumab emtansine after SRS cannot be enrolled.
* Contraindications to gadolinium contrast-enhanced MRI (eg, non-compatible pacemaker, eGFR\<30, gadolinium allergy).

Where it's running

• University of Chicago
  Chicago, Illinois, United States Recruiting

Study contacts

• Principal investigator: Steven J. Chmura, M.D., Ph.D. — University of Chicago
• Study coordinator: Robyn Hseu
• Email: rhseu@radonc.uchicago.edu
• Phone: 773-834-3198

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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.