Frameless stereotactic radiosurgery for intact brain metastases
The Clinical Relevance of Margins in Frameless Stereotactic Radiosurgery for Intact Brain Metastases: a Randomized Trial of 0 vs 2 mm Margins
This trial will test whether omitting planning target volume (PTV) margins during frameless stereotactic radiosurgery changes progression-free survival in adults with 1–5 brain metastases.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 166 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Chicago Academic / other |
| Drugs / interventions | trastuzumab, Chemotherapy, immunotherapy, radiation |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT02747303 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults 18 or older with histologically confirmed systemic cancer, ECOG performance status 0–2, life expectancy ≥3 months, and 1–5 measurable intraparenchymal brain metastases (each ≤3.0 cm) who can undergo MRI and give informed consent.
Not a fit: Patients with germ cell tumors, small cell carcinoma, hematologic malignancies, metastases in the brainstem or within 7 mm of the optic apparatus, more than five lesions, or poor performance status are unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, patients might get smaller treated volumes with similar tumor control, potentially lowering radiation exposure to normal brain and reducing side effects.
How similar studies have performed: Stereotactic radiosurgery is an established treatment for brain metastases, but randomized data specifically testing omission of PTV margins are limited, with only small series suggesting feasibility.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Chicago, Illinois
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.