A Single Arm Study of Neurocognitive Outcomes in Patients With Brain Metastases Managed With Stereotactic Radiosurgery (SRS)

Stopped early · Not applicable

Conditions studied: Brain Metastases

In brief

The purpose of this study is to find out what effects, good and/or bad, stereotactic radiosurgery (Gamma knife) has on brain metastasis(es). Gamma knife radiosurgery is a way of giving radiation therapy to the brain in a very focused way, so that nearby parts of the brain receive very little exposure to radiation. No incisions are involved. Imaging technology is used to pinpoint the location of the tumor. In this study, the investigators are also trying to find out how the tumor and/or treatment affect brain function over time. The investigators will do this by performing a series of neurocognitive assessments, or tests of memory, reasoning, and higher brain function, before treatment and at regular intervals after treatment.

Key facts

Study ID

NCT01821443

Run by

University of California, San Francisco

People needed

10

Starts

2012-12-01

Expected to finish

2015-10-22

Last updated by the study team

2018-01-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Pathologically (histologically or cytologically) proven diagnosis of a non-hematopoietic malignancy other than small cell lung cancer and germ cell malignancy within 5 years of registration. If the original histologic proof of malignancy is greater than 5 years, then pathological confirmation is required (e.g. from extra- or intracranial disease).
• Patients with 1-10 measurable brain metastases on a diagnostic-quality contrast-enhanced magnetic resonance imaging (MRI) scan obtained within 30 days prior to registration.
• Patients with ≤10 cc largest tumor volume, and ≤15 cc total tumor volume.
• History/physical examination within 30 days prior to registration.
• If an open biopsy is performed, the patient must be at least one week post biopsy. This requirement does not apply to patients who undergo stereotactic biopsies.
• Age ≥18 years.
• Karnofsky performance status ≥70 (RTOG recursive partitioning analysis (RPA) Class I \& II).
• Minimum pre-treatment oNCF score ≥70.
• Patients must provide study-specific informed consent prior to study entry.
• Women of child-bearing age must have a negative, quantitative serum pregnancy test ≤14 days prior to study entry, or have a documented reason why such a test is not necessary (e.g. history of tubal ligation).
• Patients must be able to speak and read English fluently (required for the use of online NCF testing).

You may not qualify if…

• Clinical (e.g. multiple cranial nerve deficits in the absence of obvious radiographic disease to explain symptoms) or radiographic evidence of leptomeningeal disease.
• Patients with measurable brain metastasis(es) resulting from small cell lung cancer and/or germ cell malignancy
• No documentation of prior cytotoxic or other therapy for malignancy if such therapy was previously received. Note: This does not apply to patients with synchronous metastases at initial diagnosis.
• Contraindication to MR imaging, such as implanted metal devices or foreign bodies, severe claustrophobia, or contraindications to contrast agent administration.
• Estimated glomerular filtration rate (eGFR) <60 within 6 weeks prior to registration.
• Prior radiation therapy to the brain.
• Severe, active co-morbidity, defined as follows:
• Unstable angina, and/or congestive heart failure requiring hospitalization within the last 6 months.
• Transmural myocardial infarction within the last 6 months.
• Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration.
• Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects.
• Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization, or precluding study therapy at the time of registration.
• Uncontrolled, clinically significant cardiac arrhythmias.
• Radiologic or clinical evidence of hydrocephalus, or history of previously treated hydrocephalus.
• Women of childbearing potential and male participants who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the radiation treatment involved in this study is potentially teratogenic.

Where it is running

• University of California, San Francisco — San Francisco, California, United States

Full record on ClinicalTrials.gov

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