Clinical trial NCT02514915: Pre-operative Stereotactic Radiosurgery Followed by Resection for Brain Metastases
Official title: Phase II Study Determining the Efficacy of Pre-operative Stereotactic Radiosurgery Followed by Resection for Brain Metastases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malignant Neoplasm Brain
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2015-08-04
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary goal of this research study is to determine the efficacy of giving pre-operative radiosurgery to patients pending resection of a brain metastasis.

Detailed description: Patients who have a brain metastasis surgically resected have very high local rates of disease relapse, and so the standard of care is to give either whole brain irradiation or stereotactic radiosurgery to the resection cavity in order to prevent disease recurrence. Stereotactic radiosurgery generally offers a more favorable side effect profile than whole brain irradiation, but targeting a surgical resection bed can be a challenge, as post surgical changes make it more difficult to distinguish residual tumor from scar, and much of the dose ends up being focused on the center of the resection cavity, where there are no substantial tumor cells.

Eligibility criteria: Inclusion Criteria:

* Life expectancy of at least 12 weeks
* Karnofsky performance status of at least 50
* No contraindications to MRI scanning with intravenous contrast.
* MRI scan consistent with brain metastasis as per radiology report.
* Target lesion must measure at least 15 mm in at least one dimension, and no more than 4 cm in any dimension.
* Patients must have an extra-cranial primary tumor diagnosis.
* Patients will have no more than 4 distinct lesions within the brain. At least 1 lesion has been recommended for surgical removal based on size, symptomology, or regional mass effect on the brain.
* Additional lesions will each be treated with stereotactic radiosurgery.
* Patients with a documented symptomatic lesion size smaller than 3cm requiring clinical surgical resection
* Must be aware of the neoplastic nature of his/her disease and willingly provide written, informed consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks and discomforts

Exclusion Criteria:

* Primary tumor histology of lymphoma, leukemia, multiple myeloma or germ cell tumor. Moribund status or status epilepticus.
* Supratentorial mass effect with greater than 5 mm of midline shift or hydrocephalus. Infratentorial mass effect with fourth ventricle effacement or hydrocephalus.
* More than four additional diagnosed brain metastases.
* Contraindication to general anesthesia.
* Adjacent tumor location to optic apparatus or brainstem, precluding achievement of meaningful dose with SRS.
* Primary brain tumor.
* Contraindication to MRI scans or intravenous contrast.
* Pregnant and breast-feeding females.

Primary outcomes:
measure: Local Control Rate (LCR) at 6 months
timeFrame: At 6 months
measure: Local Control Rate (LCR) at 12 months
timeFrame: At 12 months
measure: Local Control Rate (LCR) at 24 months
timeFrame: At 24 months
Secondary outcomes:
measure: 6-month Overall Survival (OS)
timeFrame: At 6 months
measure: 12-month Overall Survival (OS)
timeFrame: At 12 months
measure: 24-month Overall Survival (OS)
timeFrame: At 24 months
measure: Distant Intracranial Failure
timeFrame: Up to 3 years
measure: Health Related Quality of Life (HRQL) - FACT - BR (FACT - BRAIN)
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Shadyside Radiation Oncology Department
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Christopher A Wilke, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: