Status:
TERMINATED
A Single Arm Study of Neurocognitive Outcomes in Patients With Brain Metastases Managed With Stereotactic Radiosurgery (SRS)
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
North American Gamma Knife Consortium
Conditions:
Brain Metastases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 thera...
Detailed Description
This will be a prospective, multi-institution, non-randomized trial of neurocognitive outcomes in patients with multiple, newly-diagnosed brain metastases managed primarily with stereotactic radiosurg...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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.
Key Trial Info
Start Date :
December 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 22 2015
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01821443
Start Date
December 1 2012
End Date
October 22 2015
Last Update
January 23 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of California, San Francisco
San Francisco, California, United States, 94143