Neurocognition in Patients With Multiple Brain Metastases Treated With Radiosurgery

NCT ID: NCT03184038

Last Updated: 2025-05-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-21
• Study Completion Date: 2026-09-30

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.

Conditions

Metastatic Malignant Neoplasm in the Brain; Metastatic Malignant Solid Neoplasm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Supportive care (SRS/SBRT, neurocognitive testing)

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.

Group Type: EXPERIMENTAL

Cognitive Assessment

Intervention Type: PROCEDURE

Undergo assessment of neurocognitive function

Stereotactic Radiosurgery

Intervention Type: RADIATION

Undergo SRS

Stereotactic Body Radiation Therapy

Intervention Type: RADIATION

Undergo SBRT

Quality-of-Life Assessment

Intervention Type: OTHER

Ancillary studies

Interventions

Cognitive Assessment

Undergo assessment of neurocognitive function

Intervention Type: PROCEDURE

Stereotactic Radiosurgery

Undergo SRS

Intervention Type: RADIATION

Stereotactic Body Radiation Therapy

Undergo SBRT

Intervention Type: RADIATION

Quality-of-Life Assessment

Ancillary studies

Intervention Type: OTHER

Other Intervention Names

Stereotactic External Beam Irradiation; stereotactic external-beam radiation therapy; stereotactic radiation therapy; Stereotactic Radiotherapy; stereotaxic radiation therapy; stereotaxic radiosurgery; SBRT; SABR; Stereotactic Ablative Body Radiation Therapy; Quality of Life Assessment

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sidney Kimmel Cancer Center at Thomas Jefferson University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wenyin Shi, MD

Role: PRINCIPAL_INVESTIGATOR

Sidney Kimmel Cancer Center at Thomas Jefferson University

Locations

Jefferson Health New Jersey

Sewell, New Jersey, United States

Site Status: NOT_YET_RECRUITING

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Wenyin Shi, MD

Role: CONTACT

wenyin.shi@jefferson.edu

(215) 955-6702

Facility Contacts

Karishma Kurowski, MPH

Role: primary

karishma.kurowski@jefferson.edu

856-341-5199

Wenyin Shi, MD

Role: primary

215-955-6702

Related Links

https://www.jeffersonhealth.org/clinical-specialties/cancer

Sidney Kimmel Cancer Center

http://hospitals.jefferson.edu/

Thomas Jefferson University Hospital

Other Identifiers

JT 9331

Identifier Type: OTHER

Identifier Source: secondary_id

16D.651

Identifier Type: -

Identifier Source: org_study_id