Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT03184038

Neurocognition in Patients With Multiple Brain Metastases Treated With Radiosurgery

Led by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University · Updated on 2025-05-15

90

Participants Needed

2

Research Sites

501 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Neurocognition in Patients With Multiple Brain Metastases Treated With Radiosurgery

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Pathologically proven solid tumor malignancy (except for small cell lung cancer and germ cell tumor)
  • Karnofsky performance status of 60 or higher
  • Presence of 1 to 10 brain metastases with no more than two lesions or cavities measuring 3 cm or larger
  • Maximum diameter of brain metastasis or resection cavity no more than 6 cm
  • Serum creatinine less than or equal to 3 mg/dL and creatinine clearance at least 30 ml/min
  • Psychological ability and general health adequate to complete study requirements and follow-up
  • Willingness to complete neurocognitive assessments as scheduled
  • Women of childbearing potential must have a negative pregnancy test within 21 days before enrollment
  • Women of childbearing potential and men must agree to use effective contraception before and for 4 months after last treatment
  • Ability to provide written informed consent and speak English
Not Eligible

You will not qualify if you...

  • Diagnosis of glioma or other World Health Organization grade II through IV primary brain tumor
  • Brain surgery within 14 days before enrollment
  • Planned chemotherapy during radiosurgery
  • Presence of leptomeningeal metastases
  • More than one seizure per week during the past 2 months despite adequate anticonvulsant therapy
  • Pregnant women

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

Jefferson Health New Jersey

Sewell, New Jersey, United States, 08080

Not Yet Recruiting

2

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, United States, 19107

Actively Recruiting

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Research Team

W

Wenyin Shi, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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