NCT02747303

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
166

participants targeted

Target at P75+ for phase_2

Timeline
27mo left

Started Sep 2023

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress54%
Sep 2023Aug 2028

First Submitted

Initial submission to the registry

April 19, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 21, 2016

Completed
7.4 years until next milestone

Study Start

First participant enrolled

September 5, 2023

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 22, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 22, 2028

Last Updated

December 29, 2025

Status Verified

December 1, 2025

Enrollment Period

5 years

First QC Date

April 19, 2016

Last Update Submit

December 19, 2025

Conditions

Brain Metastases

Keywords

brain metastasesStereotactic Radiosurgery

Outcome Measures

Primary Outcomes (1)

  • Progression free survival (PFS) rates estimated by the Kaplan-Meier method at 6 months

    Progression free survival (PFS) rates will be estimated by the Kaplan-Meier method and the 0-mm and 2-mm groups will be compared via the log-rank statistic with a one-sided test of significance, using follow-up data up to 6 months.

    6 months

Secondary Outcomes (10)

  • Progression free survival (PFS) rates estimated by the Kaplan-Meier method

    2 years

  • Overall survival rates

    2 years

  • Rates of radiation necrosis

    2 years

  • Rates of pseudoprogression

    2 years

  • Local failure rates

    2 years

  • +5 more secondary outcomes

Study Arms (2)

Stereotactic Radiosurgery to 2 mm GTV to PTV margins

ACTIVE COMPARATOR
Procedure: Stereotactic Radiosurgery

Stereotactic Radiosurgery to 0 mm GTV to PTV margins

EXPERIMENTAL
Procedure: Stereotactic Radiosurgery

Interventions

Stereotactic RadiosurgeryPROCEDURE

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

Stereotactic Radiosurgery to 0 mm GTV to PTV marginsStereotactic Radiosurgery to 2 mm GTV to PTV margins

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeuticsStereotaxic TechniquesNeurosurgical ProceduresSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Steven J. Chmura, M.D., Ph.D.

    University of Chicago

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Robyn Hseu

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 19, 2016

First Posted

April 21, 2016

Study Start

September 5, 2023

Primary Completion (Estimated)

August 22, 2028

Study Completion (Estimated)

August 22, 2028

Last Updated

December 29, 2025

Record last verified: 2025-12

Locations

US(1)