Neurocognition in Patients With Multiple Brain Metastases Treated With Radiosurgery
Neurocognition in Patients With Multiple Brain Metastases Treated With Radiosurgery: A Phase II Study
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
90 participants
Feb 21, 2017
INTERVENTIONAL
Conditions
Summary
This phase II trial studies the neurological function in patients with multiple brain metastases undergoing stereotactic radiosurgery (SRS) or stereotactic body radiation therapy (SBRT). Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Assessment of neurocognitive function may help show that SRS preserves neurological function in patients with multiple brain metastases better than SBRT.
Eligibility
Inclusion Criteria9
- Pathologically proven solid tumor malignancy (except for small cell lung cancer \[SCLC\], germ cell tumor)
- Karnofsky performance status >= 60
- to 10 brain metastases (mets) (no more than two lesions and/or cavities >= 3 cm in maximum diameter)
- Maximum diameter of brain metastasis or resection cavity is 6 cm
- Serum creatinine =< 3 mg/dL and creatinine clearance >= 30 ml/min
- Patients must have the psychological ability and general health that permits completion of the study requirements and required follow up; patients must be willing to complete neurocognitive assessments at pre-specified time points outlined in the protocol
- Women of childbearing potential must have a negative beta-human chorionic gonadotropin (HCG) pregnancy test documented within 21 days prior to registration
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for 4 months after last dose
- Patient able to provide his/her own written informed consent and speak English
Exclusion Criteria6
- Patient with diagnosis of glioma, or other World Health Organization (WHO) grade II - IV primary brain tumor
- Prior brain surgery =< 14 days prior to enrollment
- Planned chemotherapy during radiosurgery
- Leptomeningeal metastases
- Intractable seizures while on adequate anticonvulsant therapy-more than 1 seizure per week for the past 2 months
- Pregnant women
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Interventions
Undergo assessment of neurocognitive function
Undergo SRS
Undergo SBRT
Ancillary studies
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT03184038