Frameless Stereotactic Radiosurgery for Intact Brain Metastases

Brain Metastases Clinical Trial

Official title:

The Clinical Relevance of Margins in Frameless Stereotactic Radiosurgery for Intact Brain Metastases: a Randomized Trial of 0 vs 2 mm Margins

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02747303
• Other study ID #: IRB15-1476
• Status: Recruiting
• Phase: Phase 2
• Start date: June 10, 2016
• Est. completion date: May 10, 2026

Study information

• Verified date: April 2023
• Source: University of Chicago
• Contact: Robyn Hseu
• Phone: 773-834-3198
• Email: rhseu[@]radonc.uchicago.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 166
• Est. completion date: May 10, 2026
• Est. primary completion date: May 10, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Brain Metastases
• Brain Neoplasms
• Neoplasm Metastasis

Intervention

Procedure:
• Stereotactic Radiosurgery
The SRS dose will depend on the maximum diameter of the gross tumor volume (GTV)

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival (PFS) rates estimated by the Kaplan-Meier method at 6 months		6 months
Secondary	Progression free survival (PFS) rates estimated by the Kaplan-Meier method		2 years
Secondary	Overall survival rates		6 years
Secondary	Rates of radiation necrosis		2 years
Secondary	Rates of pseudoprogression		2 years
Secondary	Local failure rates		2 years
Secondary	Rate of acute central nervous system (CNS) Common Terminology Criteria for Adverse Events (CTCAE) v4.0 grade 2 and higher toxicities		90 days
Secondary	Rate of late central nervous system (CNS) Common Terminology Criteria for Adverse Events (CTCAE) v4.0 grade 2 and higher toxicities		6 years
Secondary	Rates of distant intracranial failure		2 years
Secondary	Rates of salvage therapy		2 years
Secondary	Association between dose and risk of radionecrosis or pseudoprogression		2 years