Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT02747303

Frameless Stereotactic Radiosurgery for Intact Brain Metastases

Led by University of Chicago · Updated on 2025-12-29

166

Participants Needed

1

Research Sites

259 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Frameless Stereotactic Radiosurgery for Intact Brain Metastases

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults 18 years or older with an ECOG Performance Status of 0 to 2 and life expectancy of at least 3 months
  • Histologically confirmed systemic cancer with 1 to 5 brain metastases visible on contrast-enhanced MRI
  • Brain lesions must be well-defined and measurable, with maximum tumor diameter of 3.0 cm or less
  • At least one lesion measuring 1.0 cm or larger and 0.5 cm or larger in the perpendicular diameter
  • Negative pregnancy test within 14 days before CT simulation for women who can become pregnant
  • Ability to understand and willing to sign informed consent
Not Eligible

You will not qualify if you...

  • Diagnosis of germ cell tumor, small cell carcinoma, or blood cancers
  • Brain metastases located in the brain stem, midbrain, pons, medulla, or within 7 mm of optic nerves or pathways
  • Leptomeningeal disease diagnosis
  • Cranial radiotherapy within 90 days before enrollment or prior stereotactic radiosurgery to treated lesions
  • Chemotherapy or immunotherapy within 14 days before stereotactic radiosurgery; hormonal therapy allowed
  • For Her2-positive breast cancer, no anti-Her2 therapy within 14 days before stereotactic radiosurgery; no trastuzumab emtansine planned after radiosurgery
  • Contraindications to gadolinium MRI such as incompatible pacemaker, severe kidney impairment, or gadolinium allergy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Chicago

Chicago, Illinois, United States, 60637

Actively Recruiting

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Research Team

R

Robyn Hseu

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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