Recruiting

Radiosurgery

Sponsor:

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Code:

NCT03184038

Conditions

Metastatic Malignant Neoplasm in the Brain

Metastatic Malignant Solid Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cognitive Assessment

Stereotactic Radiosurgery

Stereotactic Body Radiation Therapy

Quality-of-Life Assessment

Study Details

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.

Conditions

Metastatic Malignant Neoplasm in the Brain

Metastatic Malignant Solid Neoplasm

Study ID

NCT03184038

Start date

Feb 21, 2017

Status verified date

May, 2026

Completion date

Sep 30, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

90 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

Cognitive Assessment

Undergo assessment of neurocognitive function

Stereotactic Radiosurgery

Undergo SRS

Stereotactic Body Radiation Therapy

Undergo SBRT

Quality-of-Life Assessment

Ancillary studies

Primary outcome measure

  • Neurocognitive function as measured by neurocognitive decline on a battery of tests [ Time Frame: At 4 months ]

Central Contacts and Locations

Central contacts

Wenyin Shi, MD

(215) 955-6702wenyin.shi@jefferson.edu

Locations

Sidney Kimmel Cancer Center at Thomas Jefferson University

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Wenyin Shi, MD

(215) 955-6702

More Information

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Last update posted

May 22, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University on 2026-05-22.