Recruiting
Phase 2

Observational Study

Sponsor:

University of Chicago

Code:

NCT02747303

Conditions

Brain Metastases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Stereotactic Radiosurgery

Study Details

Brief summary:

This is a randomized study to determine if not treating planning target volume (PTV) margins during radiation therapy worsens progression free survival rates in patients with brain metastases.

Conditions

Brain Metastases

Study ID

NCT02747303

Start date

Sep 5, 2023

Status verified date

Dec, 2025

Completion date

Aug 22, 2028

Anticipated

Primary completion date

Aug 22, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

166 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Stereotactic Radiosurgery to 2 mm GTV to PTV margins

experimental: Stereotactic Radiosurgery to 0 mm GTV to PTV margins

Interventions

Stereotactic Radiosurgery

The SRS dose will depend on the maximum diameter of the gross tumor volume (GTV)

Primary outcome measure

  • Progression free survival (PFS) rates estimated by the Kaplan-Meier method at 6 months [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Robyn Hseu

773-834-3198rhseu@radonc.uchicago.edu

Locations

University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Robyn Hseu

rhseu@radonc.uchicago.edu

Principal Investigator:

Steven J. Chmura, M.D., Ph.D.

More Information

Sponsor

University of Chicago

Last update posted

Dec 29, 2025

Last verified

Dec, 2025

Keywords

  • brain metastases
  • Stereotactic Radiosurgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Chicago on 2025-12-29.