Assessment of Neurocognitive Function in Patients With Multiple Brain Metastases Undergoing Stereotactic Radiosurgery or Stereotactic Body Radiation Therapy



Status:Recruiting
Conditions:Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/6/2019
Start Date:February 21, 2017
End Date:May 2022
Contact:Wenyin Shi, MD
Email:wenyin.shi@jefferson.edu
Phone:(215) 955-6702

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Neurocognition in Patients With Multiple Brain Metastases Treated With Radiosurgery: A Phase II Study

This phase II trial studies the neurological function in patients with multiple brain
metastases undergoing stereotactic radiosurgery (SRS) or stereotactic body radiation therapy
(SBRT). Assessment of neurocognitive function may help show that SRS preserves neurological
function in patients with multiple brain metastases better than SBRT

PRIMARY OBJECTIVES:

I. Assessment of neurocognitive function at months 4.

SECONDARY OBJECTIVES:

I. Assessment of neurocognitive function at months 2, 6, 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.

Inclusion Criteria:

- Pathologically proven solid tumor malignancy (except for small cell lung cancer
[SCLC], germ cell tumor)

- Karnofsky performance status >= 60

- 1 to 10 brain 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 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
We found this trial at
3
sites
Reading, Pennsylvania 19601
Phone: 484-628-0900
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Philadelphia, Pennsylvania 19107
Phone: 215-955-6702
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Philadelphia, PA
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Philadelphia, Pennsylvania 19114
Principal Investigator: Shari Rudoler, MD
Phone: 215-612-4300
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Philadelphia, PA
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