Clinical trial NCT03184038: Neurocognition in Patients With Multiple Brain Metastases Treated With Radiosurgery
Official title: Neurocognition in Patients With Multiple Brain Metastases Treated With Radiosurgery: A Phase II Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Metastatic Malignant Neoplasm in the Brain
Metastatic Malignant Solid Neoplasm
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2017-06-12
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: PRIMARY OBJECTIVES:

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.

Eligibility criteria: 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 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 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

Primary outcomes:
measure: Neurocognitive function as measured by neurocognitive decline on a battery of tests
timeFrame: At 4 months
Secondary outcomes:
measure: Change in neurocognitive function as measured by neurocognitive decline on a battery of tests conducted by the primary investigator or a trained member of the clinical team
timeFrame: Baseline to up to 12 months
measure: Change in symptom burden as measured by the MD Anderson Symptom Inventory- Brain Tumor Module (MDASI-BT)
timeFrame: Baseline to up to 12 months
measure: Quality adjusted survival and health outcomes as measured by the European Quality of Life Five Dimension Five Level scale questionnaire (EQ-5D-5L)
timeFrame: Up to 12 months
measure: Local control as measured by magnetic resonance imaging
timeFrame: Up to 12 months
measure: Progression free survival (PFS)
timeFrame: Up to 12 months
measure: Overall survival (OS)
timeFrame: Up to 12 months
measure: Incidence of adverse events graded according to the Common Terminology Criteria for Adverse Events version 5.0
timeFrame: Up to 30 days after SRS
Other outcomes:
Locations:
city: Sewell
country: United States
facility: Jefferson Health New Jersey
state: New Jersey
city: Philadelphia
country: United States
facility: Sidney Kimmel Cancer Center at Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Sidney Kimmel Cancer Center at Thomas Jefferson University
name: Wenyin Shi, MD
role: PRINCIPAL_INVESTIGATOR
References: