Clinical trial NCT02747303: 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
Overall status: SUSPENDED
Phase: PHASE2
Conditions: Brain Metastases
Keywords: brain metastases
Stereotactic Radiosurgery
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2016-04-21
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Progression free survival (PFS) rates estimated by the Kaplan-Meier method at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Progression free survival (PFS) rates estimated by the Kaplan-Meier method
timeFrame: 2 years
measure: Overall survival rates
timeFrame: 2 years
measure: Rates of radiation necrosis
timeFrame: 2 years
measure: Rates of pseudoprogression
timeFrame: 2 years
measure: Local failure rates
timeFrame: 2 years
measure: Rate of acute central nervous system (CNS) Common Terminology Criteria for Adverse Events (CTCAE) v4.0 grade 2 and higher toxicities
timeFrame: 90 days
measure: Rate of late central nervous system (CNS) Common Terminology Criteria for Adverse Events (CTCAE) v4.0 grade 2 and higher toxicities
timeFrame: 2 years
measure: Rates of distant intracranial failure
timeFrame: 2 years
measure: Rates of salvage therapy
timeFrame: 2 years
measure: Association between dose and risk of radionecrosis or pseudoprogression
timeFrame: 2 years
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Steven J. Chmura, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: