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Frameless Stereotactic Radiosurgery for Intact Brain Metastases

Primary Purpose

Brain Metastases

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Stereotactic Radiosurgery

About this trial

This is an interventional treatment trial for Brain Metastases focused on measuring brain metastases, Stereotactic Radiosurgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

University of ChicagoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Stereotactic Radiosurgery to 2 mm GTV to PTV margins

Stereotactic Radiosurgery to 0 mm GTV to PTV margins

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Overall survival rates

Rates of radiation necrosis

Rates of pseudoprogression

Local failure rates

Rate of acute central nervous system (CNS) Common Terminology Criteria for Adverse Events (CTCAE) v4.0 grade 2 and higher toxicities

Rate of late central nervous system (CNS) Common Terminology Criteria for Adverse Events (CTCAE) v4.0 grade 2 and higher toxicities

Rates of distant intracranial failure

Rates of salvage therapy

Association between dose and risk of radionecrosis or pseudoprogression

Full Information

NCT ID

NCT02747303

First Posted

April 19, 2016

Last Updated

April 26, 2023

Sponsor

University of Chicago

1. Study Identification

Unique Protocol Identification Number

NCT02747303

Brief Title

Frameless Stereotactic Radiosurgery for Intact Brain Metastases

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 10, 2016 (Actual)

Primary Completion Date

May 10, 2026 (Anticipated)

Study Completion Date

May 10, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Chicago

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Brain Metastases

Keywords

brain metastases, Stereotactic Radiosurgery

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

166 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Stereotactic Radiosurgery to 2 mm GTV to PTV margins

Arm Type

Active Comparator

Arm Title

Stereotactic Radiosurgery to 0 mm GTV to PTV margins

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

Stereotactic Radiosurgery

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

6 months

Secondary Outcome Measure Information:

Title

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

Time Frame

2 years

Title

Overall survival rates

Time Frame

6 years

Title

Rates of radiation necrosis

Time Frame

2 years

Title

Rates of pseudoprogression

Time Frame

2 years

Title

Local failure rates

Time Frame

2 years

Title

Rate of acute central nervous system (CNS) Common Terminology Criteria for Adverse Events (CTCAE) v4.0 grade 2 and higher toxicities

Time Frame

90 days

Title

Rate of late central nervous system (CNS) Common Terminology Criteria for Adverse Events (CTCAE) v4.0 grade 2 and higher toxicities

Time Frame

6 years

Title

Rates of distant intracranial failure

Time Frame

2 years

Title

Rates of salvage therapy

Time Frame

2 years

Title

Association between dose and risk of radionecrosis or pseudoprogression

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Robyn Hseu

Phone

773-834-3198

rhseu@radonc.uchicago.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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

Organizational Affiliation

University of Chicago

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Chicago

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60637

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Robyn Hseu

rhseu@radonc.uchicago.edu

First Name & Middle Initial & Last Name & Degree

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

12. IPD Sharing Statement

Learn more about this trial

Frameless Stereotactic Radiosurgery for Intact Brain Metastases

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