Frameless Stereotactic Radiosurgery for Intact Brain Metastases

Phase 2

Suspended

• Conditions: Brain Metastases
• Interventions: Procedure: Stereotactic Radiosurgery

• Registration Number: NCT02747303
• Lead Sponsor: University of Chicago

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-04-19
• Study First Submitted QC: 2016-04-19
• Study First Posted: 2016-04-21
• Study Start: 2023-09-05
• Primary Completion: 2024-08-22
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-17
• Last Update Posted: 2024-12-20
• Study Completion: 2025-08-22

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 166

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.

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stereotactic Radiosurgery to 2 mm GTV to PTV margins	Stereotactic Radiosurgery	-
Stereotactic Radiosurgery to 0 mm GTV to PTV margins	Stereotactic Radiosurgery	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Progression free survival (PFS) rates estimated by the Kaplan-Meier method	2 years	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.
Overall survival rates	2 years	Time from Stereotactic Radiosurgery (SRS) completion to death.
Rates of radiation necrosis	2 years	To evaluate the superiority of frameless LINAC-based SRS using 0 mm margins compared to 2 mm margins in reducing rates of radiation necrosis.
Rates of pseudoprogression	2 years	To evaluate the superiority of frameless LINAC-based SRS using 0 mm margins compared to 2 mm margins in reducing rates of radiation pseudoprogression.
Local failure rates	2 years	Local failure and OS rates at 6 months, 1 year and 2 years will be estimated by the Kaplan-Meier method, comparing arms via the log-rank statistic.
Rate of acute central nervous system (CNS) Common Terminology Criteria for Adverse Events (CTCAE) v4.0 grade 2 and higher toxicities	90 days	Any acute CTCAE v4.0 CNS Grade 2+ and Grade 3+ toxicities, within 90 days of SRS completion (toxicity must be specified).
Rate of late central nervous system (CNS) Common Terminology Criteria for Adverse Events (CTCAE) v4.0 grade 2 and higher toxicities	2 years	To compare rates of late (greater than 90 days from SRS) CTCAE v4.0 CNS Grade 2+ and Grade 3+ toxicities.
Rates of distant intracranial failure	2 years	The appearance of new non-target lesions ≥5 mm following completion of radiotherapy will be considered distant intracranial failure. If a non-target lesion \<5 mm is found on a later scan to have increased to ≥ 5 mm, distant intracranial failure will be declared at the date of the earliest scan showing the new lesion.
Rates of salvage therapy	2 years	Time to initiation of any combination of salvage Stereotactic Radiosurgery (SRS), Whole Brain Radiation Therapy WBRT, or neurosurgical resection for intracranial failure.
Association between dose and risk of radionecrosis or pseudoprogression	2 years	To determine association between V10Gy and V12Gy all tissue, whole brain and normal brain parameters and risk of radionecrosis or pseudoprogression.

Trial Locations

Locations (1)

University of Chicago; 🇺🇸 Chicago, Illinois, United States