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Assessment of Neurocognitive Function in Patients with Multiple Brain Metastases Undergoing Stereotactic Radiosurgery or Stereotactic Body Radiation Therapy
Trial Status: active
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.
Inclusion Criteria
Pathologically proven solid tumor malignancy (except for germ cell tumor)
Male or female, Age >= 18 years
Karnofsky performance status >= 60
1 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
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 Criteria
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
Additional locations may be listed on ClinicalTrials.gov for NCT03184038.
I. Assessment of neurocognitive function at months 4.
SECONDARY OBJECTIVES:
I. Assessment of neurocognitive function at months 4 and 12 as measured by neurocognitive decline on a battery of tests.
II. Assessment of symptom burden, as measured by the M.D. Anderson Symptom Inventory- Brain Tumor Module (MDASI-BT).
III. Assessment of quality adjusted survival and health outcomes using the European Quality of Life Five Dimension Five Level scale questionnaire (EQ-5D-5L).
IV. Assessment of local control, in brain control.
V. Assessment of progression free survival (PFS), and overall survival (OS).
VI. Assessment of side effects and toxicities.
OUTLINE:
Patients undergo SRS on day 1 or SBRT for 3 fractions over days 1-7 and undergo neurocognitive testing at baseline, 4, and 12 months after undergoing SRS or SBRT.
After completion of study, patients are followed up at 2, 4, 6, 8, 10, and 12 months.
Trial PhasePhase II
Trial Typetreatment
Lead OrganizationThomas Jefferson University Hospital
